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 intentionto-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.
BACKGROUND: During invasive mechanical ventilation, secretions accumulate in the subglottic space; consequently, there is a risk of aspiration of these secretions into the airway during cuff deflation and extubation. To minimize this risk, 2 extubation methods are used. The first consists of introducing a suction catheter into the endotracheal tube (ETT) and the trachea. After initiating suctioning, the cuff is deflated and the ETT is removed together with the suction catheter. The second technique involves applying positive pressure to the ETT using a resuscitation bag. Once the manual breath is delivered, the ETT cuff is deflated and the ETT is removed without suction. The aim of this laboratory study is to determine the existence and magnitude of differences in leak volume during cuff deflation and extubation using various combinations of positive pressure with or without endotracheal suctioning.
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