Safety of Positive Pressure Extubation Technique.

BACKGROUND: Laboratory studies suggest applying positive pressure without endotracheal suction during cuff deflation and extubation. Although some studies reported better physiological outcomes (e.g. arterial blood gases) with this technique, the safety of positive pressure extubation technique has not been well studied. The aim of this study was to determine the safety of the positive-pressure extubation technique compared with the traditional extubation technique in terms of incidence of complications. METHODS: Adult subjects who were critically ill and on invasive mechanical ventilation who met extubation criteria were included. The subjects were randomly assigned to positive-pressure extubation (n = 120) or to traditional extubation (n = 120). Sequential tests for noninferiority and, when appropriate, for superiority were performed. Positive pressure was considered noninferior if the upper limit of the CI for the absolute risk difference did not exceed a threshold of 15% in favor of the traditional group, both in per protocol and intention-to-treat analyses. A P value of <.05 was considered significant. RESULTS: A total of 236 subjects were included in the primary analysis (per protocol) (119 in the positive-pressure group and 117 in the traditional group). The incidence of overall major and minor complications, pneumonia, extubation failure, and reintubation was lower in the positive-pressure group than in the traditional group, with statistical significance for noninferiority both in the per protocol (P < .001) and intention-to-treat (P < .001) analyses. The lower incidence of major complications found in the positive-pressure group reached statistical significance for the superiority comparison, both in per protocol (P = .03) and intention-to-treat (P = .049) analyses. No statistically significant differences were found in the superiority comparison for overall complications, minor complications, pneumonia, extubation failure, and reintubation. CONCLUSIONS: Positive pressure was safe and noninferior to traditional extubation methods. Furthermore, positive pressure has shown to be superior in terms of a lower incidence of major complications. (ClinicalTrials.gov registration NCT03174509.).

Budget impact of antiretroviral therapy in a French clinic cohort.

OBJECTIVES: In this study, we first assessed costs associated with the use of antiretroviral therapy (ART) in an infectious diseases University Hospital Clinic; second, we evaluated characteristics associated with these costs and finally simulated the impact on the overall ART budget of switching first-line and second-line regimens to less-costly regimens (as effective and well tolerated). DESIGN: Cohort analysis including persons living with HIV (PLHIV) aged at least 18 years on ART to estimate ART costs during 2014. METHODS: The current study was conducted in the Bichat-Claude Bernard University Hospital Clinic in Paris, France, where 4501 PLHIV consulted in 2014. We used the medical database Nadis to describe patients' ART, characteristics and estimated costs. When assessing the budgetary impact of potential switches, we considered patients' history of failure, CD4 cell count, plasma viral load, resistance mutations, hepatitis B surface antigen or HLAB5701 profile. RESULTS: A total of 4238 of 4501 patients were on ART (94%). The total annual cost of ART prescribed was estimated at &OV0556;48 280 200 in 2014; first/second (simplification)-line regimens represented 25% (1076/4238) of the treated PLHIV and 23% (&OV0556;11 209 000) of the annual cost. For these PLHIV, we considered switches from the most common ART regimens (protease inhibitor boosted by ritonavir or nonnucleoside reverse transcriptase inhibitor + two nucleoside reverse transcriptase inhibitors) to less-expensive regimens. We found savings ranging from &OV0556;36 100 to 1472 600/year. Savings were the highest when we considered switching to generic-based regimens or from protease inhibitor-based triple therapy to protease inhibitor monotherapy. CONCLUSION: Costs associated with ART prescriptions are very high. Switches to generic-based regimens are associated with large savings. However, those targeting protease inhibitor regimens are also associated with substantial savings and should be considered.