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Low power vs standard power transpupillary thermotherapy in patients with age-related macular degeneration and subfoveal choroidal neovascularization ineligible for photodynamic therapy.

AIM: To assess the effect of standard power vs low power transpupillary thermotherapy (TTT) in patients with active subfoveal choroidal neovascularization secondary to age-related macular degeneration ineligible for photodynamic therapy (PDT) by original treatment of age-related macular degeneration with photodynamic therapy (TAP) study group recommendations. METHODS: Retrospective review of 79 patients with active predominantly occult subfoveal choroidal neovascularization or predominantly classic subfoveal choroidal neovascularization but Snellen visual acuity <20/200. All patients were treated with TTT administered via a Mainster wide field fundus contact lens with a retinal power/diameter coefficient of 248 mW/mm in the standard power (n=27) and 181 mW/mm in the low power group (n=52). The primary outcome was stabilization (<1 Snellen line change) or improvement (two or more Snellen lines) in visual acuity. Clinical and fluorescein angiographic resolution of overlying exudation was documented. RESULTS: At 24 month follow-up, 17 patients (63%) in the standard power and 36 patients (69%) in the low power group achieved stable or improved vision. Improved vision (mean three lines) was observed in 22% of the standard power and 23% of the low power group. Overlying exudation was reduced clinically with minimal or no leakage on fluorescein angiogram in 85% of standard power and 90% of low power group. Subgroup analysis in the low power group demonstrated a visual benefit in patients with subfoveal lesions, which had any classic component. CONCLUSIONS: Low power TTT is as effective as standard power in stabilizing or improving vision and reducing overlying exudation in patients with active subfoveal choroidal neovascularization ineligible for PDT.

Aged↗

Standardized RT-PCR analysis of fusion gene transcripts from chromosome aberrations in acute leukemia for detection of minimal residual disease. Report of the BIOMED-1 Concerted Action: investigation of minimal residual disease in acute leukemia.

Prospective studies on the detection of minimal residual disease (MRD) in acute leukemia patients have shown that large-scale MRD studies are feasible and that clinically relevant MRD-based risk group classification can be achieved and can now be used for designing new treatment protocols. However, multicenter international treatment protocols with MRD-based stratification of treatment need careful standardization and quality control of the MRD techniques. This was the aim of the European BIOMED-1 Concerted Action 'Investigation of minimal residual disease in acute leukemia: international standardization and clinical evaluation' with participants of 14 laboratories in eight European countries (ES, NL, PT, IT, DE, FR, SE and AT). Standardization and quality control was performed for the three main types of MRD techniques, ie flow cytometric immunophenotyping, PCR analysis of antigen receptor genes, and RT-PCR analysis of well-defined chromosomal aberrations. This study focussed on the latter MRD technique. A total of nine well-defined chromosome aberrations with fusion gene transcripts were selected: t(1;19) with E2A-PBX1, t(4;11) with MLL-AF4, t(8;21) with AML1-ETO, t(9;22) with BCR-ABL p190 and BCR-ABL p210, t(12;21) with TEL-AML1, t(15;17) with PML-RARA, inv (16) with CBFB-MYH11, and microdeletion 1p32 with SIL-TAL1. PCR primers were designed according to predefined criteria for single PCR (external primers A <--> B) and nested PCR (internal primers C <--> D) as well as for 'shifted' PCR with a primer upstream (E5' primer) or downstream (E3' primer) of the external A <--> B primers. The 'shifted' E primers were designed for performing an independent PCR together with one of the internal primers for confirmation (or exclusion) of positive results. Various local RT and PCR protocols were compared and subsequently a common protocol was designed, tested and adapted, resulting in a standardized RT-PCR protocol. After initial testing (with adaptations whenever necessary) and approval by two or three laboratories, the primers were tested by all participating laboratories, using 17 cell lines and patient samples as positive controls. This testing included comparison with local protocols and primers as well as sensitivity testing via dilution experiments. The collaborative efforts resulted in standardized primer sets with a minimal target sensitivity of 10-2 for virtually all single PCR analyses, whereas the nested PCR analyses generally reached the minimal target sensitivity of 10-4. The standardized RT-PCR protocol and primer sets can now be used for molecular classification of acute leukemia at diagnosis and for MRD detection during follow-up to evaluate treatment effectiveness.

Acute Disease↗

Gas chromatographic determination of volatile anaesthetic agents in blood. Part 1. Preparation of standard gas mixtures of volatile anaesthetic agents.

A method for preparing standard gas mixtures of the volatile anaesthetics halothane, enflurane and isoflurane is described. Static mixtures of gases of known concentration can be prepared manometrically by measuring the required pressure of anaesthetic gas into a bulb and diluting to atmospheric pressure with air. Standard gas mixtures in the concentration range 0-4% V/V can be prepared with an accuracy of +/- 0.01% V/V, and the relative standard error of measurements of a single standard concentration is less than 0.8%. Significant adsorptive losses in the gas sampling valve were observed for gas standards prepared in the absence of any diluent gas. These losses were not detected for measurements of standards made up to atmospheric pressure in air. A comparison with calibration procedures currently in practice is presented.

Anesthetics↗

Effervescent and standard formulations of ranitidine--a comparison of their pharmacokinetics and pharmacology.

BACKGROUND: An effervescent formulation of ranitidine may be absorbed faster and achieve a faster onset of action than conventional tablet form. The aim of this study was to compare the effects of effervescent formulations of ranitidine with equivalent dose standard tablets, in terms of intragastric pH and plasma pharmacokinetics in the initial 6 h following dosing. METHODS: Fifteen fasting healthy males, aged 18-31 (mean 29) years, were each randomly given, at weekly intervals, 150 mg standard and effervescent ranitidine and 300 mg standard and effervescent ranitidine. Ambulatory gastric pH was performed and plasma drug levels measured at regular intervals. RESULTS: Plasma ranitidine levels increased more rapidly with both effervescent formulations compared with standard tablets as indicated by mean area under curve (AUC) at 1 h (P < 0.001). However, the pH profiles produced by all four treatments were similar with a steep rise in pH at 40-60 min to give a sustained level of pH 7 for the following 5 h. The effervescent formulations produced a transient rise in pH immediately following dosing, and for 300 mg this rise was significantly different at 10-20 min compared with the standard tablet (median pH 4.75 vs. 2.3, P < 0.05). CONCLUSIONS: Plasma drug levels increase more rapidly following effervescent ranitidine. Effervescent and standard formulations of 150 and 300 mg are all equally effective in producing gastric pH 7 after 1 h. However, effervescent formulations produce an early transient rise in pH which may be of clinical benefit.

Adolescent↗

Detection of karyotypic aberrations in acute myeloblastic leukaemia: a prospective comparison between PCR/FISH and standard cytogenetics in 140 patients with de novo AML.

In 140 patients with de novo acute myeloid leukaemia (AML) standard cytogenetics were compared with RT-PCR for the detection of t(8;21), t(15;17) and inv(16) and fluorescence in situ hybridization (FISH) for numerical aberrations of chromosomes 7, 8, X and Y. RT-PCR detected 18 cases with t(8;21), 12 with t(15;17) and seven with inv(16). In two cases with t(8;21), two with t(15;17) and four with inv(16) these aberrations had not been detected by standard cytogenetics. There were no false negative PCR results. In 12 patients with these chromosomal changes, standard cytogenetics revealed additional chromosomal aberrations. In 16 patients sole numerical aberrations of the chromosomes 7, 8, X or Y were found by FISH. In these patients the sensitivity of FISH and standard cytogenetics was comparable. In 87 patients no aberrations could be found by PCR and FISH whereas in 24 of these patients standard cytogenetics revealed an abnormal karyotype. These data recommend the combination of standard cytogenetics and molecular techniques to improve the sensitivity for the detection of genetic lesions in AML. Once chromosomal markers have been identified by combined analysis these markers could be used to monitor residual disease during/after chemotherapy, by RT-PCR and/or FISH.

Adult↗

Electrocardiographic changes during prolonged coronary artery occlusion in man: comparison of standard and high-frequency recordings.

Detection of acute myocardial ischaemia using electrocardiographic methods is generally based on assessment of the ST segments in the standard 12-lead electrocardiogram (ECG). Several studies have also shown changes in high-frequency QRS components during acute ischaemia. The purpose of the present study was to determine the changes in high-frequency QRS components during prolonged percutaneous transluminal coronary angioplasty (PTCA) and to compare these changes with ST-segment deviations in the standard 12-lead ECG. The study population consisted of 19 patients receiving prolonged PTCA. Standard and high-resolution signal-averaged ECGs were recorded before and during balloon inflation. The high-resolution recordings were performed using bipolar X, Y and Z leads. The QRS complexes in the high-resolution signal-averaged ECGs were analysed within a bandwidth of 150-250 Hz. During inflation, significant reductions in high-frequency QRS components were observed (12-72%). Changes in the high-frequency QRS components were seen in four of the patients without ST-segments deviation in the standard ECG. The correlation between the ST-segment deviation and the reduction in high-frequency QRS components was weak (r = 0.27). Acute coronary artery occlusion produces changes in high-frequency QRS components, even in the absence of ST-segment deviation in the standard ECG. Further studies need to be carried out to evaluate whether analysis of high-frequency QRS components could provide a method for detecting myocardial ischaemia and give additional information to that available in the ST segment in the standard ECG.

Adult↗

Assessment of weight-based versus standard dosing of heparin in patients with unstable angina.

OBJECTIVE: To assess whether a weight-based dosing regimen (80 u/kg + 18 u/kg/h) or a standard-fixed dose regimen (5000 u + 1000 u/h) of heparin is more appropriate in patients with unstable angina (UA). METHOD: A drug use evaluation was conducted. Patient data for all patients weighing less than 100 kg who were in the coronary care unit of a Veterans Administration Hospital and who received heparin for UA (>24 h) over a 7-month period were included. For the first 4 months, patients were given standard heparin dosing and in the final 3 months patients were given heparin based on weight. The proportion of patients achieving activated partial thromboplastin times (aPTTs) that were at least therapeutic during therapy, the time to achieve the aPTT at a level that was at least therapeutic, and the number of patients with aPTTs over the therapeutic range were compared between groups. RESULTS: Patients in the group receiving weight-based heparin therapy (n = 23) were significantly more likely to achieve an aPTT that was at least therapeutic than patients receiving standard therapy (n = 42, 100% vs. 76%, respectively, P = 0.011). When all the patients in each group who achieved an aPTT that was at least therapeutic were compared, the weight-based group achieved the levels significantly faster than the standard-fixed dosing group (7.3 +/- 6.1 vs. 22.6 +/- 17.6 h, respectively, P = 0.0003). However, the use of weight-based dosing was associated with a higher incidence of achieving supertherapeutic aPTTs than standard therapy (78.3% vs. 50.0%, respectively, P = 0.049). CONCLUSION: Patients with UA may achieve therapeutic aPTTs faster than those on standard therapy but they also have a higher risk of achieving a supertherapeutic aPTT.

Aged↗

Reliability and credibility of an angoff standard setting procedure in progress testing using recent graduates as judges.

INTRODUCTION: Progress testing is an assessment method that samples the complete domain of knowledge that is considered pertinent to undergraduate medical education. Because of the comprehensive nature of this test, it is very difficult to set a passing score. We obtained a progress test standard using an Angoff procedure with recent graduates as judges. This paper reports on the reliability and credibility of this approach. METHODS: The Angoff procedure was applied to a sample of 146 progress test items. The items were judged by a panel of eight recently graduated students. Generalizability theory was used to investigate the reliability as a function of the number of items and judges. Credibility was judged by comparing the pass/fail rates resulting from the standard arrived at by the Angoff procedure with those obtained using a relative and a fixed standard. RESULTS: The results indicate that an acceptable error score can be achieved, yielding a precision within one percentage on the scoring scale, by using 10 judges on a full-length progress test (i.e. 250 items). The pass/fail rates associated with the Angoff standard came closest to those of the relative standard, which takes variations in test difficulty into account. A high correlation was found between item-Angoff estimates and the item P-values. CONCLUSION: The results of this study suggest that the Angoff procedure, using recently graduated students as judges, is an appropriate standard setting method for a progress test.

Education, Medical, Undergraduate↗

Reproducibility of clinical performance assessment in practice using incognito standardized patients.

BACKGROUND: The reproducibility of authentic assessment methods has been investigated for objective structured clinical examinations (OSCEs) and video assessment in general practice, but not for assessment with incognito standardized patients. PURPOSE: To investigate the reproducibility of assessment with incognito standardized patients. METHODS: A total of 27 Dutch rheumatologists in 16 hospitals were each visited by 8 incognito standardized patients presenting with different rheumatological disorders. After each visit, the standardized patient completed a case-specific checklist containing items on medical history, physical examination and management. Over a 20-month period, 254 incognito visits took place, of which 201 were first visits. The standardized patient was detected by the rheumatologist in 2 cases only. These encounters were not included in the analysis. Generalizability theory was used to investigate the reproducibility of the assessment. RESULTS: One fifth of the variance can be attributed to variation between rheumatologists. The largest variance is due to the variation in difficulty among cases. A reproducible assessment requires 3 hours of testing time (6 cases) if it is obtained through a norm-referenced interpretation of scores and 7 hours of testing time (14 cases) if it is obtained through an absolute interpretation of scores. CONCLUSION: The reproducibility of performance assessment in clinical practice by incognito standardized patients is similar to that of other authentic measurements for the assessment of clinical competence and performance.

Analysis of Variance↗

Evaluation of standardized versus individualized total parenteral nutrition regime for neonates less than 33 weeks gestation.

OBJECTIVE: To evaluate the difference in nutrient intakes and biochemical responses in newborn infants <33 weeks gestation who received standardized versus individualized total parenteral nutrition (TPN) regimes. METHOD: Comparison of nutrient intakes and daily biochemical responses in newborn infants <33 weeks gestation who received standardized regime versus those who received individualized TPN regimes from day 2 to day 7 of life. RESULTS: Twenty-seven infants in the standardized TPN group and 31 infants in the individualized TPN group were compared. There were no statistically significant differences (P > 0.05) between the two groups in gestation, birthweight, Clinical Risk Index for Babies scores, daily TPN volume intake and biochemical responses. Infants in the standardized TPN group received less sodium (P < 0.01) and no potassium on day 2 as required, more protein (P < 0.02) every day, and more calcium and phosphate (P < 0.02 from day 4). CONCLUSION: There were no significant clinical and statistical differences in biochemical responses in newborn infants <33 weeks gestation who received standardized versus individualized TPN regimes during the first week of life. The economic cost of TPN provision using standardized TPN formulation was approximately 30% lower.

Cost-Benefit Analysis↗

The regulation of patient-reported outcome claims: need for a flexible standard.

We review the FDA's policies for the regulation of patient-reported outcome (PRO) claims such as quality of life, productivity, satisfaction and symptom reports and suggest alternative standards for substantiation. We base our review on FDA regulatory activities and public statements in the field of advertising substantiation. We compare these activities to the FDA's label substantiation policies and policies for health-economic (HE) claim substantiation. There is an overt inconsistency between the FDA's policies for substantiation of PRO claims in product labels and substantiation for such claims in advertising materials. This results in a higher standard for PRO claims in promotional vehicles than in product labels. Rather than relying on a "substantial evidence" standard, the FDA should consider a more flexible standard, such as the one currently applied to information included in the Clinical Trials section of product labels, or adopting a "competent and reliable scientific evidence" standard as set forth in Section 114 of the Food and Drug Administration Modernization Act (FDAMA) for HE data. We conclude that there needs to be greater consistency for substantiation in product labels and promotional materials. Furthermore, reconceptualizing most PRO claims as benefit extrapolations as opposed to efficacy information suggests a less rigorous standard is necessary.

Advertising↗

Rapid suppression of hematopoiesis by standard or pegylated interferon-alpha.

BACKGROUND & AIMS: Treatment of chronic hepatitis C with interferon (IFN)-alpha often has hematotoxic effects. We evaluated the effects of acute vs. chronic and standard vs. pegylated IFN-alpha on hematopoiesis. METHODS: We studied hematopoiesis in 46 patients with chronic hepatitis C receiving single high-dose IN-Falpha2b followed by daily dose standard or weekly pegylated IFN before combination antiviral therapy. RESULTS: Single high-dose therapy resulted in a significant drop in hemoglobin (HB), leukocytes, and platelet count. Although platelets, stimulated by a significant increase in thrombopoietin (TPO), and leukocytes recovered quickly, HB remained below baseline for 7 days. Daily standard or weekly pegylated IFN-alpha leads to a more pronounced drop in all 3 lineages with concomitant increases in TPO and erythropoietin (EPO). No difference was observed between standard and pegylated IFN, except for HB, which fell more during pegylated IFN therapy. Consecutive combination antiviral therapy aggravated the anemia but not the drop in leukocytes or thrombocytes. CONCLUSIONS: The drop in all 3 hematopoietic lineages through IFN-alpha treatment, high-dose standard, standard daily dose, or pegylated, is caused by a combination of bone marrow inhibition and probably some other rapid acting mechanisms. Hematopoietic growth factors are increased as a consequence but cannot overcome the bone marrow suppression.

Adult↗

Scottish national bronchoscopy audit: a prospective multicentre study of 3316 cases against agreed standards. Scottish Thoracic Society.

INTRODUCTION: Bronchoscopy guidelines address issues of patient and operator safety but do not give guidance on the expected yield of the procedure. Realistic standards for several outcome measures of bronchoscopy for investigating bronchial carcinoma have been derived by Scottish clinicians from a published national study. The present study describes the use of these agreed standards in prospective audit. METHODS: All Society members in Scotland (population 5.1 million) were invited to participate. Data were collected for 1 year and coded anonymously. STANDARDS: 1. Supervising bronchoscopist to have completed at least 100 procedures; 2. histology to be positive in 80% of cases where tumour seen; 3. 35%-55% of bronchoscopies to reveal a diagnosis; 4. 60% of patients admitted for bronchoscopy to be day cases; 5. 80% of day case patients to be in hospital for less than 6 h; 6. 90% of male patients and 80% of female patients willing to have repeat bronchoscopy. RESULTS: Three thousand, three hundred and sixteen bronchoscopies were performed by 45 senior pulmonologists at 22 centres. One centre reached all the standards and five centres met five standards. There was wide national variation in histological spectrum, incidence of small cell cancer ranged from 12% to 25% between centres. Participants found their own data helpful in identifying local areas for improvement. CONCLUSION: Bronchcoscopy standards set locally by practising pulmonologists can be used in collaborative audit to identify areas for improving practice. Variation in histology may be accounted for by case-mix or pathology techniques.

Bronchoscopy↗

[Emergency tracheotomy in Göttingen minipigs. Comparison: standard technique versus Nu-Trake cricothyrotomy set].

STUDY OBJECTIVE: To compare the time required, success rate and complication rate of the standard surgical approach for cricothyrotomy versus a prepacked kit in regard to the experience of the surgeon. METHODS: The cricothyrotomies were performed in Goettingen mini-pigs (n = 14) under general anaesthesia. 7 different surgeons (2 Otorhinolaryngologists, 2 Emergency Physicians, 3 medical students) used each technique (standard surgical approach and Nu-Trake device) once to perform the cricothyrotomy without prior practice. RESULTS: The fastest time to do the cricothyrotomy with Nu-Trake was 40 s, the slowest 93 s and the mean time of all 7 surgeons was 58 +/- 18 s. Using the standard approach it took 42 s up to 154 s until ventilation with a mean time of 106 +/- 48 s. The use of Nu-Trake was significantly faster than the standard surgical approach (p < 0.05, t-test). Otorhinolaryngologists were quicker using the standard technique (46 s versus 58 s with Nu-Trake), whereas each surgeon of the other two groups (emergency physicians and medical students) was quicker with the Nu-Trake Set (58 +/- 21 s) than with the conventional method (135 +/- 18 s). The number of complications was similar with both methods, but a difference was detected in the type and severity of the complication: An injury of the posterior tracheal wall was observed twice with Nu-Trake. CONCLUSIONS: Experienced personnel should maintain the standard surgical approach for cricothyrotomy. Inexperienced personnel can use the Nu-Trake device which was found to be quicker as it facilitates the procedure, but causes more severe complications. We recommend to practise cricothyrotomy regularly in human cadavers, in the animal model if possible or on mannequins to be sufficiently trained in advanced airway management.

Animals↗

Comparison of standard and steerable catheters for bile duct cannulation in ERCP.

BACKGROUND AND STUDY AIMS: The aim of the study was to compare two steerable endoscopic retrograde cholangiopancreatography (ERCP) catheters with regard to speed and safety in cannulating the common bile duct. PATIENTS AND METHODS: A standard cannula, a short-nosed sphincterotome, and a bendable catheter were used. At two tertiary centres, a total of 312 patients were randomly assigned to receive treatment with one of three catheters and either by a trainee or an expert endoscopist. When cannulation failed, a further attempt was made with a different catheter. If this failed, a change in operator or other manoeuvres followed. The following were assessed: time to cholangiography and deep cannulation, number of attempts and success rates of cannulation, number of pancreatic duct injections, success of catheter cross-over, and complication rates. RESULTS: Both steerable catheters were significantly better for the initial cholangiogram than the standard catheter (standard catheter 75 %, bendable catheter 84 %, sphincterotome 88 %; P = 0.038), with no significant differences between the bendable catheter and the sphincterotome. Both were also better for deep cannulation of the bile duct (standard cannula 66 %, bendable catheter 69 %, sphincterotome 78 %; P = 0.15). When the standard catheter failed, a steerable catheter succeeded in 26 % of cases. Trainees experienced greater benefit from using steerable catheters. For experts, the bendable catheter was the quickest to achieve cholangiography and deep cannulation. Further manoeuvres had an 85-90 % success rate in allowing biliary access. Twenty of 23 needle-knife papillotomies (87 %) were successful when other methods had failed. The overall ERCP success rate was 97 %. Pancreatitis occurred in 5.3 % of cases. CONCLUSIONS: Steerable catheters allow faster access and can succeed when a standard catheter fails. If cannulation is difficult, changing the catheter should be considered at an early stage. Needle-knife papillotomy is a successful technique in expert hands.

Adult↗

[Quality standards and their assurance for study centers in the competence network malignant lymphoma].

BACKGROUND: The aim of most of the trials of the Competence Network Malignant Lymphoma is to optimize the standard treatment of lymphoma using only registered drugs in the case of medicinal therapies (quality assurance protocols). In contrast to regulatory trials, special regulations for quality assurance protocols are not given by the legislature. However, there is agreement that also for this type of studies the declaration of Helsinki and the Guidelines of the International Conference on Harmonisation (ICH) are relevant. The ICH Guidelines must be formulated to take into account the specific situation of quality assurance protocols and to ensure at the same time efficiency and transparency of these studies. This is the aim of the quality management of the study groups in the Competence Network Malignant Lymphoma. METHOD: The quality assurance measures already established in the study groups are being expanded to a comprehensive quality management concept in agreement with the ICH Guidelines and allowing for the situation of quality assurance protocols. To this end, a working group for quality management (AG-QM) has been set up to define and establish general quality standards for all aspects of planning, executing and evaluating quality assurance protocols in study centers. RESULTS: The AG-QM has developed a system of Standard Operating Procedures (SOPs) reflecting all working procedures of the study centers. Furthermore, evaluation parameters for the quality of trial execution have been identified and the harmonisation of documentation parameters has been initiated. Term definitions are collected and their harmonisation coordinated. CONCLUSIONS: Development of quality standards is the first step of quality management. To ensure the realisation of these standards in practice, the AG-QM will establish quality assurance measures including continuous reevaluation of quality criteria and actualization of quality standards if necessary.

Helsinki Declaration↗

Birth weight and gestational age standards based on regional perinatal network data: an analysis of risk factors.

The most frequently used set of gestational age-birth weight curves in the United States is the Colorado (C) standard published in 1963. To investigate the usefulness of this standard in an urban population at sea level, we examined the birth weight vs gestational age data from 56,675 singleton liveborn infants born between 1982 and 1985 in the University of Illinois (UI) perinatal network of 13 hospitals. Between 32 and 42 weeks, the UI 10th, median, and 90th percentile weights were significantly higher than those of Colorado. At term gestations the Colorado 10th and 90th percentile weights were the same as the UI 3rd and 80th percentile weights, respectively. Using the UI and Colorado standards for 10th and 90th percentile weights, the study sample was divided into five subgroups. To evaluate the risk prevalence, we examined the frequency of neonatal death, low, and very low Apgar scores (below seven and three, respectively), respiratory distress, maternal hypertension, and diabetes in the five subgroups. The highest frequency of adverse factors was seen in infants classified as small for gestational age (SGA) by both standards, but overall, the size-for-gestation grouping was better accomplished using the UI rather than the C standard. In 9188 infants (16.2%) classified into wrong weight-gestation subgroups using the Colorado standard, the prevalence of actual risk factors was at variance with the group to which they were assigned. This included 3632 (6.4%) SGA infants who were grouped as appropriate for gestational age (AGA), and 5556 (9.8%) AGA infants grouped as large for gestational age.(ABSTRACT TRUNCATED AT 250 WORDS)

Birth Weight↗

A comparison of active compression-decompression cardiopulmonary resuscitation with standard cardiopulmonary resuscitation for cardiac arrests occurring in the hospital.

BACKGROUND: Recent studies have demonstrated improved cardiopulmonary circulation during cardiac arrest with the use of a hand-held suction device (Ambu CardioPump) to perform active compression-decompression cardiopulmonary resuscitation (CPR). The purpose of this study was to compare active compression-decompression with standard CPR during cardiac arrests in hospitalized patients. METHODS: All patients over the age of 18 years who had a witnessed cardiac arrest while hospitalized at our center were enrolled in this trial; they were randomly assigned according to their medical-record numbers to receive either active compression-decompression or standard CPR. The study end points were the rates of initial resuscitation, survival at 24 hours, hospital discharge, and neurologic outcome. Compressions were performed according to the recommendations of the American Heart Association (80 to 100 compressions per minute; depth of compression, 3.8 to 5.1 cm [1.5 to 2 in.]; and 50 percent of the cycle spent in compression). RESULTS: Sixty-two patients (45 men and 17 women) with a mean age (+/- SE) of 68 +/- 2 years were entered into the trial. Sixty-two percent of the patients who underwent active compression-decompression were initially resuscitated, as compared with 30 percent of the patients who received standard CPR (P < 0.03); 45 percent of the patients who underwent active compression-decompression survived for at least 24 hours, as compared with 9 percent of patients who underwent standard CPR (P < 0.004). Two of the 62 study patients survived to hospital discharge; both were randomly assigned to receive active compression-decompression. Neurologic outcome, as measured by the Glasgow coma score, was better with active compression-decompression (8.0 +/- 1.3) than with standard CPR (3.5 +/- 0.3; P < 0.02). CONCLUSIONS: In this preliminary study, we found that, as compared with standard CPR, active compression-decompression CPR improved the rate of initial resuscitation, survival at 24 hours, and neurologic outcome after in-hospital cardiac arrest. Larger trials will be required to assess the potential benefit in terms of long-term survival.

Aged↗