Detrimental Effects of Filling Laryngotracheal Airways To Excessive Pressure (DEFLATE-P): a quality improvement initiative.

BACKGROUND: This quality improvement (QI) project was performed at a single center to determine the incidence of postoperative complications associated with use of cuffed airway devices. An educational program was then completed that involved training our anesthesia providers about complications related to excessive cuff pressure and how to utilize a quantitative cuff pressure measurement device (manometer). The impact of this educational initiative was assessed by comparing the incidence of postoperative complications associated with the use of airway devices before and after the training period. METHODS: After approval by our institution's Institutional Review Board, a pre-intervention (baseline) survey was obtained from 259 adult patients after having undergone surgery with general anesthesia with the use of an endotracheal tube (ETT) or laryngeal mask airway (LMA). Survey responses were used to determine the baseline incidence of sore throat, hoarseness, and dysphagia. Once these results were obtained, education was provided to the anesthesia department members addressing the complications associated with excessive cuff pressures, appropriate cuff pressures based on manufacturer recommendations, and instructions on the use of a quantitative monitor to determine cuff pressure (manometry). Clinical care was then changed by requiring intraoperative cuff pressure monitoring throughout our institution for all surgical patients. After this educational period, 299 patients completed the same survey describing postoperative airway complications. RESULTS: The use of manometry reduced the incidence of moderate-to-severe postoperative sore throat in the pre- vs. post-intervention groups (35 patients vs 31 patients, p = 0.045), moderate to severe hoarseness (30 patients vs 13, patients p = 0.0001), and moderate-to-severe dysphagia (13 patients vs 5 patients, p = 0.03). CONCLUSION: Caring for patients in the perioperative setting frequently entails placement of an airway device. This procedure is associated with several potential complications, including sore throat, coughing, and vocal cord damage. Our quality improvement initiative has shown that intraoperative management of intra-cuff pressure based on manometry is feasible to implement in clinical practice and can reduce postoperative airway complications.

A blinded, randomized comparison of immediate-release and extended-release carbamazepine capsules in manic and depressed bipolar subjects.

BACKGROUND: The anticonvulsant carbamazepine is approved by the FDA for treatment of acute mania. It is available in 2 formulations: immediate-release (IR) and extended-release carbamazepine capsules (ERCC). The relative efficacy of these formulations in acutely ill bipolar patients has not been previously investigated. METHODS: This study is a subanalysis of a 3-month, blinded, equal, random-assignment comparison of adverse effect load of an IR carbamazepine formulation (Tegretol) and ERCC (Equetro) in type I or type II bipolar patients already receiving carbamazepine or clinically determined to benefit from carbamazepine treatment. Dosages were titrated to patients' clinical needs. Subjects who scored >15 on the Montgomery Asberg Depression Rating Scale (MADRS) or >14 on the Young Mania Rating Scale (YMRS) were included in this analysis. The primary outcome measures were the relative mood scores at the end of the study. RESULTS: At the end of 3 months of treatment, all patients improved compared with their baseline, but there was no difference in mood ratings in subjects with an initial MADRS >15 (ERCC, 18.2 +/- SD 11.9, vs IR, 12.0 +/- 4.5; P = .3) or YMRS >15 (ERCC, 6.5 +/- 6.4, vs IR, 4.7 +/- 3.1; P = .7). When compared with their baseline, patients receiving IR improved earlier than patients receiving ERCC. There were no differences in overall adverse events in patients receiving IR or ERCC (23.1 +/- 13.42 vs 22.3 +/- 13.40; P = .9). CONCLUSIONS: Carbamazepine is effective in treating symptoms of both mania and depression, and there are no significant differences in the relative efficacy of the IR or ERCC formulations.

Adverse event load in bipolar participants receiving either carbamazepine immediate-release or extended-release capsules: a blinded, randomized study.

In epilepsy, slow-release formulations of carbamazepine (CBZ) have fewer adverse events (AEs) compared with immediate-release (IR) formulations. As CBZ is used for mania, it is important to determine whether a similar pattern exists for bipolar patients. This was a 3-month, blinded, random-assignment study to an IR formulation or extended-release carbamazepine capsules (ERCC, Equetro) in type I or type II bipolar patients already on CBZ or clinically determined to benefit from it. Dosages were titrated to patients' clinical needs. Mood and AE ratings were performed at baseline and monthly for 3 months. There was no difference in mood ratings or in the total level of AEs in patients receiving IR or ERCC. However, autonomic AEs (5.0+/-1.1 vs. 2.0+/-0.7, P = 0.02) and gastrointestinal AEs (1.6+/-0.4 vs. 0.6+/-0.3, P = 0.05) were significantly less in participants receiving ERCC. CBZ level in patients receiving ERCC were higher (9.2+/-1.7 vs. IR 7.2+/-1.3 microg/ml, P = 0.005). Total AE load was directly related to CBZ level only in participants receiving the IR formulation. In conclusion, ERCC is better tolerated than IR CBZ in bipolar patients.