Effectiveness of Continuous Endotracheal Cuff Pressure Control for the Prevention of Ventilator-Associated Respiratory Infections: An Open-Label Randomized, Controlled Trial

Vu Quoc Dat, Lam Minh Yen, Huynh Thi Loan, Vu Dinh Phu, Nguyen Thien Binh, Ronald B Geskus, Dong Huu Khanh Trinh, Nguyen Thi Hoang Mai, Nguyen Hoan Phu, Nguyen Phu Huong Lan, Tran Phuong Thuy, Nguyen Vu Trung, Nguyen Trung Cap, Dao Tuyet Trinh, Nguyen Thi Hoa, Nguyen Thi Thu Van, Vy Thi Thu Luan, Tran Thi Quynh Nhu, Hoang Bao Long, Nguyen Thi Thanh Ha, Ninh Thi Thanh Van, James Campbell, Ehsan Ahmadnia, Evelyne Kestelyn, Duncan Wyncoll, Guy E Thwaites, Nguyen Van Hao, Le Thanh Chien, Nguyen Van Kinh, Nguyen Van Vinh Chau, H Rogier van Doorn, C Louise Thwaites, Behzad Nadjm, Vu Quoc Dat, Lam Minh Yen, Huynh Thi Loan, Vu Dinh Phu, Nguyen Thien Binh, Ronald B Geskus, Dong Huu Khanh Trinh, Nguyen Thi Hoang Mai, Nguyen Hoan Phu, Nguyen Phu Huong Lan, Tran Phuong Thuy, Nguyen Vu Trung, Nguyen Trung Cap, Dao Tuyet Trinh, Nguyen Thi Hoa, Nguyen Thi Thu Van, Vy Thi Thu Luan, Tran Thi Quynh Nhu, Hoang Bao Long, Nguyen Thi Thanh Ha, Ninh Thi Thanh Van, James Campbell, Ehsan Ahmadnia, Evelyne Kestelyn, Duncan Wyncoll, Guy E Thwaites, Nguyen Van Hao, Le Thanh Chien, Nguyen Van Kinh, Nguyen Van Vinh Chau, H Rogier van Doorn, C Louise Thwaites, Behzad Nadjm

Abstract

Background: An endotracheal tube cuff pressure between 20 and 30 cmH2O is recommended to prevent ventilator-associated respiratory infection (VARI). We aimed to evaluate whether continuous cuff pressure control (CPC) was associated with reduced VARI incidence compared with intermittent CPC.

Methods: We conducted a multicenter open-label randomized controlled trial in intensive care unit (ICU) patients within 24 hours of intubation in Vietnam. Patients were randomly assigned 1:1 to receive either continuous CPC using an automated electronic device or intermittent CPC using a manually hand-held manometer. The primary endpoint was the occurrence of VARI, evaluated by an independent reviewer blinded to the CPC allocation.

Results: We randomized 600 patients; 597 received the intervention or control and were included in the intention to treat analysis. Compared with intermittent CPC, continuous CPC did not reduce the proportion of patients with at least one episode of VARI (74/296 [25%] vs 69/301 [23%]; odds ratio [OR] 1.13; 95% confidence interval [CI] .77-1.67]. There were no significant differences between continuous and intermittent CPC concerning the proportion of microbiologically confirmed VARI (OR 1.40; 95% CI .94-2.10), the proportion of intubated days without antimicrobials (relative proportion [RP] 0.99; 95% CI .87-1.12), rate of ICU discharge (cause-specific hazard ratio [HR] 0.95; 95% CI .78-1.16), cost of ICU stay (difference in transformed mean [DTM] 0.02; 95% CI -.05 to .08], cost of ICU antimicrobials (DTM 0.02; 95% CI -.25 to .28), cost of hospital stay (DTM 0.02; 95% CI -.04 to .08), and ICU mortality risk (OR 0.96; 95% CI .67-1.38).

Conclusions: Maintaining CPC through an automated electronic device did not reduce VARI incidence.

Clinical trial registration: NCT02966392.

Keywords: associated pneumonia; associated respiratory infection; continuous cuff pressure control; hospital acquired pneumonia; ventilator.

© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America.

Figures

Figure 1.
Figure 1.
CONSORT flowchart of participants into the trial. Other reasons including: presumed to die within 48 hours after admission (39), hold on trial recruitment period (27), expected to extubation within 48 hours (13), transferred to another hospital within 24 hours (7), unable to provide the consent (5), and unspecified reasons (73). Abbreviations: CPC, cuff pressure control; ICU, intensive care unit.
Figure 2.
Figure 2.
Time-to-event analyses without stratification by Tetanus—ITT population. Abbreviations: ITT, intention-to-treat; VARI, ventilator-associated respiratory infection.

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