Dataset Information

Rapid-flow expulsion maneuver in subglottic secretion clearance to prevent ventilator-associated pneumonia: a randomized controlled study.

ABSTRACT:

Background

Following endotracheal intubation, clearing secretions above the endotracheal tube cuff decreases the incidence of ventilator-associated pneumonia (VAP); therefore, subglottic secretion drainage (SSD) is widely advocated. Our group developed a novel technique to remove the subglottic secretions, the rapid-flow expulsion maneuver (RFEM). The objective of this study was to explore the effectiveness and safety of RFEM compared with SSD.

Methods

This study was a single-center, prospective, randomized and controlled trial, conducted at Respiratory Intensive Care Unit (ICU) of Beijing Chao-Yang Hospital, a university-affiliated tertiary hospital. The primary outcome was the incidence of VAP, assessed for non-inferiority.

Results

Patients with an endotracheal tube allowing drainage of subglottic secretions (n = 241) were randomly assigned to either the RFEM group (n = 120) or SSD group (n = 121). Eleven patients (9.17%) in the RFEM group and 13 (10.74%) in the SSD group developed VAP (difference, - 1.59; 95% confidence interval [CI] [- 9.20 6.03]), as the upper limit of 95% CI was not greater than the pre-defined non-inferiority limit (10%), RFEM was declared non-inferior to SSD. There were no statistically significant differences in the duration of mechanical ventilation, ICU mortality, or ICU length of stay and costs between groups. In terms of safety, no accidental extubation or maneuver-related barotrauma occurred in the RFEM group. The incidence of post-extubation laryngeal edema and reintubation was similar in both groups.

Conclusions

RFEM is effective and safe, with non-inferiority compared to SSD in terms of the incidence of VAP. RFEM could be an alternative method in first-line treatment of respiratory ICU patients. Trial registration This study has been registered on ClinicalTrials.gov (Registration Number: NCT02032849, https://clinicaltrials.gov/ct2/show/NCT02032849 ); registered on January 2014.

SUBMITTER: Li Y

PROVIDER: S-EPMC8222955 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Ventilator-associated pneumonia (VAP) is a prevalent and costly nosocomial infection related to instrumentation of the airway with an endotracheal tube (ETT), enabling microaspiration of contaminated secretions. Modification of the ETT design to reduce microaspiration and/or biofilm formation may play an important role in VAP prevention. However, there is insufficient evidence to provide strong recommendations regarding the use of modified ETT and unaddressed safety concerns.We performed a pilot randomized controlled trial comparing two modified ETTs designed specifically to prevent VAP, with the standard ETT, to test the feasibility of and inform planning for a large, pivotal, randomized trial.This study was conducted with institutional review board approval under exception from informed consent. We randomized in a blinded fashion patients undergoing emergency endotracheal intubation both out of and in hospital to receive one of three different ETT types: (1) a polyurethane-cuffed tube (PUC-ETT), (2) a polyurethane-cuffed tube equipped with a port for continuous aspiration of subglottic secretions (PUC-CASS-ETT), or a (3) standard polyvinylchloride-cuffed tube (PVC-ETT). In addition to investigating feasibility and safety, the study coprimary end points were tracheal bacterial colonization reaching a cfu count >10(6) cfu per milliliter and the incidence of invasively diagnosed VAP.A total of 102 subjects were randomized and met the eligibility criteria. Randomization procedures performed well and integrity of blinding at randomization was maintained. The majority of intubations occurred in the hospital setting (n?=?77), and the remainder occurred out of hospital (n?=?25). Compared with the PVC-ETT, there were no significant differences in tracheal colonization for PUC-ETT (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.31-3.09) or for PUC-CASS-ETT (OR, 1.26; 95% CI, 0.42-3.76). There were no differences in the risk of invasively diagnosed VAP (OR, 1.14; 95% CI, 0.21-6.08 for PUC-ETT; OR, 1.47; 95% CI, 0.30-7.10 for PUC-CASS-ETT), or of clinically diagnosed VAP by either clinical signs or chest radiograph criteria. We did not observe unexpected or serious adverse events related to the devices.A randomized trial of ETTs inserted during emergency intubation for the prevention of VAP is feasible and did not appear to carry heightened safety concerns. These preliminary data did not suggest different patterns of tracheal colonization or occurrence of VAP among the study groups. Clinical trial registered with www.clinicaltrials.gov (NCT01744483).