Disposable inner cannula tracheotomy tube: a prospective clinical trial.
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Biomedical subjects
Publications and source records attributed to R L Wagner.
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The authors present a study in which 33 chronic schizophrenic patients who, when withdrawn from antipsychotic drug treatment for more than 2 weeks, presented with concurrent signs of akathisia and tardive dyskinesia; however, signs of akinesia, facial masking, rigidity, or dystonia were not concurrent with the patients' akathetic presentation. In a subsequent study phase, these patients were treated with antipsychotics for up to 6 weeks. The dyskinetic signs that had been dramatically more severe in those patients exhibiting akathisia following withdrawal from antipsychotic medication continued for up to 6 weeks following the renewal of antipsychotic drug therapy. These findings help to confirm a relationship between tardive dyskinesia and a persistent akathisia of later onset known as tardive akathisia.
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The efficacy of perioperative antibiotic administration during major head and neck surgery in which the wound is contaminated by saliva has been clearly established. This study was undertaken to ascertain the incidence of postoperative wound infection encountered in patients undergoing major head and neck surgery in which no contamination occurred. The records of 438 patients who had undergone parotidectomy, thyroidectomy, or submandibular gland excision were reviewed retrospectively. Eighty percent of the patients had received no perioperative antibiotic therapy. Infections developed in three (0.7%) patients during one month following surgery. One of these patients had received perioperative antibiotic prophylaxis. These data clearly demonstrate the non-efficacy of antibiotics administered in patients undergoing parotidectomy, thyroidectomy, or submandibular gland excision when no infection exists prior to surgery.
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Tardive dystonia is a relatively uncommon long term complication of neuroleptic therapy. The prevalence of this syndrome is unknown. This study, of chronic hospitalised psychiatric patients, revealed a tardive dystonia prevalence of 1.5%. Risk factors in this small population appeared to be mental retardation and convulsive therapy.
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Reconstruction of the laryngopharynx and cervical esophagus presents difficult problems. We embarked on a program using free jejunal transfer for such reconstruction. Thirty-two patients have been evaluated, with a mean follow-up of 16.7 months. Thirty-four transfers were undertaken--14 as primary repair and 20 after the failure of alternate methods. Twenty-six patients were able to achieve oral feeding. There was one immediate and one delayed failure of the graft. Twelve fistulas developed, seven of which healed spontaneously in less than 2 weeks. Four patients experienced complications related to the microvascular anastomosis which required repair. Six patients had significant dysphagia; four of these had side-to-end distal anastomosis. This technique had been abandoned and improvement resulted. We conclude that free jejunal transfer is an expeditious, safe, and reliable method of reconstruction for patients who require total laryngopharyngectomy.
A prospective clinical trial was developed to evaluate efficacy, toxicity, and patient compliance to adjuvant chemotherapy following surgery and postoperative radiation therapy in patients with squamous-cell carcinoma of the head and neck with extracapsular spread of tumor in cervical metastases. Following postoperative radiation therapy, 18 courses of methotrexate (MTX) and 5-fluorouracil (5-FU) were administered over 6 months. Fifty patients were registered. A total of 771 doses were administered. Dose reduction was required 72 times. Therapy was stopped in one patient (2%) because of toxicity. Three patients (6%) refused to complete the adjuvant therapy. Adjusted 2-year no evidence of disease (NED) survival is 66%. This study demonstrates that patients with advanced squamous-cell carcinoma of the head and neck can undertake an aggressive program of adjuvant MTX/5-FU with acceptable compliance and toxicities. Preliminary data generated in this nonrandomized study support the call for a prospective randomized multiinstitutional trial of this program.
The use of antibiotic prophylaxis does not prevent all postoperative wound infections. The records of 245 patients undergoing major head and neck surgery were reviewed to determine the cause of wound infection which developed in 17 patients. Patients with Stage IV tumors had an increased infection rate as compared to lesser stages (p less than .01). Reconstruction with a myocutaneous flap was associated with an increased infection rate when compared to primary closure or split-thickness skin graft reconstruction (p less than .001). Probable errors in surgical technique were identified in 10 of 17 infected patients. Neither weight loss, diabetes mellitus, prior radiation therapy, nor prior tracheotomy were found to increase the risk of wound infection (p greater than .05). This study lends insight into factors that may potentiate the development of wound infection despite antibiotic prophylaxis. A strategy to minimize postoperative infection is offered.
Akathisia is a common but frequently unrecognized complication of antipsychotic medication. Affected individuals report an inner discomfort which they attempt to relieve by increased motor activity. This disorder often causes dramatic changes in behavior which may be misinterpreted as signs that more, rather than less, medication is required. Diphenhydramine therapy is often effective in new-onset akathisia. Anticholinergic agents may also be of value.
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Cefazolin and moxalactam were compared in a prospective randomized double-blind trial of 118 patients undergoing oncologic head and neck surgery. Both antibiotics were given 2 g every four hours for four doses. Five infections were encountered in the cefazolin group (8.5%) and two infections in the moxalactam group (3.4%); this difference was not statistically significant. This assessment does not indicate, however, that the two regimens are equally efficacious.
T-lymphocyte subpopulations were quantitated in lymph nodes that contained metastatic tumor--or no metastasis--from patients who had squamous cell carcinoma of the upper aerodigestive tract. In addition, the lymphocyte subpopulations in peripheral blood were quantitated. The content of prostaglandin E2 within each node that was evaluated was also determined. Lymph nodes containing metastatic tumor had significantly higher helper/suppressor ratio than lymph nodes that were not involved. Quantification of the T-lymphocyte subpopulations in peripheral blood did not indicate the presence of metastatic disease. Significantly more prostaglandin E2 was present in lymph nodes containing metastatic disease, in comparison to lymph nodes without metastatic disease. Thus, both the lymphocyte subpopulations and prostaglandin levels were found to differentiate lymph nodes with metastasis from those without.
Patients who undergo major contaminated surgery of the head and neck benefit from perioperative antibiotic prophylaxis. This study was developed to determine if 5 days of antibiotic administration would be more effective than 1 day. A multi-institutional prospective randomized double-blind study was designed. Patients who were identified as requiring pedicled flap reconstruction were potential candidates for the study. Later, patients were randomly assigned to receive cefoperazone sodium for either 24 hours or 120 hours. In each case, the drug was administered intravenously, beginning 1 to 2 hours preoperatively and continued for the prescribed period. One hundred nine patients were evaluable. Fifty-three patients were assigned to 1 day of perioperative prophylaxis. Wound infection developed in ten patients (18.9%). Fifty-six patients were assigned to 5 days of perioperative antibiotic prophylaxis. Wound infection developed in 14 (25%) of these patients (P greater than .05). These data suggest that no beneficial effect from administration of antibiotics for longer than 24 hours postoperatively can be achieved in patients who undergo myocutaneous flap reconstruction.
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A prospectively designed program employing surgery, radiotherapy, and maintenance chemotherapy was initiated for patients with histologic evidence of extracapsular spread of tumor in cervical metastases. Postoperative radiotherapy consisted of 6,000 rad of cobalt 60 administered in 180- to 200-rad fractions. Chemotherapy was initiated two to four weeks following radiotherapy. Methotrexate sodium (250 mg/sq m), fluorouracil (600 mg/sq m), and leucovorin calcium were administered one day per week, two weeks of three, for a total of 18 treatments in six months. Thirty-two patients have been in the therapeutic program. Toxic reaction has been minimal and self-limiting. One patient stopped chemotherapy because of toxic reaction. One patient (3%) was noncompliant. All patients have been followed up for 18 to 33 months. Twenty-one patients remain alive and free of disease (81% determinate survival). This compares with a 36% (9/25) disease-free survival for concurrent controls and 39% survival for historic controls.
Sultamicillin, an antibiotic combining ampicillin and the beta-lactamase inhibitor sulbactam, was administered to 13 patients diagnosed as having acute sinusitis. Specimens from sinus were obtained for all 13 patients by transantral puncture. Pharmacokinetics, bacteriology, and therapeutic efficacy were assessed. Eighty-five percent (11 of 13) were cured; two treatment failures were subsequently shown to have chronic (rather than acute) sinusitis during surgical exploration. Diarrhea was frequently encountered, and Clostridium difficile-associated enteritis was documented for one patient. Beta-lactamase-producing organisms were not encountered in this study; however, this study provides impetus for further controlled clinical trials.