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


Journal

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
ISSN: 1537-6591
Titre abrégé: Clin Infect Dis
Pays: United States
ID NLM: 9203213

Informations de publication

Date de publication:
30 05 2022
Historique:
received: 20 05 2021
pubmed: 23 8 2021
medline: 3 6 2022
entrez: 22 8 2021
Statut: ppublish

Résumé

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. 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. 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). Maintaining CPC through an automated electronic device did not reduce VARI incidence. NCT02966392.

Sections du résumé

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.

Identifiants

pubmed: 34420048
pii: 6356213
doi: 10.1093/cid/ciab724
pmc: PMC9155610
doi:

Banques de données

ClinicalTrials.gov
['NCT02966392']

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1795-1803

Subventions

Organisme : Wellcome Trust
Pays : United Kingdom
Organisme : Wellcome Trust
ID : 106680/B/14/Z
Pays : United Kingdom

Informations de copyright

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

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Auteurs

Vu Quoc Dat (VQ)

Oxford University Clinical Research Unit, Wellcome Trust Africa Asia Programme, Vietnam.
Department of Infectious Diseases, Hanoi Medical University, Hanoi, Vietnam.

Lam Minh Yen (L)

Oxford University Clinical Research Unit, Wellcome Trust Africa Asia Programme, Vietnam.

Huynh Thi Loan (H)

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.

Vu Dinh Phu (V)

National Hospital of Tropical Diseases, Hanoi, Vietnam.

Nguyen Thien Binh (N)

Trung Vuong Hospital, Ho Chi Minh City, Vietnam.

Ronald B Geskus (RB)

Oxford University Clinical Research Unit, Wellcome Trust Africa Asia Programme, Vietnam.
Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.

Dong Huu Khanh Trinh (DH)

Oxford University Clinical Research Unit, Wellcome Trust Africa Asia Programme, Vietnam.

Nguyen Thi Hoang Mai (NT)

Oxford University Clinical Research Unit, Wellcome Trust Africa Asia Programme, Vietnam.

Nguyen Hoan Phu (N)

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.

Nguyen Phu Huong Lan (NP)

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.

Tran Phuong Thuy (T)

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.

Nguyen Vu Trung (N)

National Hospital of Tropical Diseases, Hanoi, Vietnam.
Trung Vuong Hospital, Ho Chi Minh City, Vietnam.

Nguyen Trung Cap (N)

National Hospital of Tropical Diseases, Hanoi, Vietnam.

Dao Tuyet Trinh (D)

National Hospital of Tropical Diseases, Hanoi, Vietnam.

Nguyen Thi Hoa (N)

National Hospital of Tropical Diseases, Hanoi, Vietnam.

Nguyen Thi Thu Van (N)

Department of Microbiology, Hanoi Medical University, Hanoi, Vietnam.

Vy Thi Thu Luan (VTT)

Department of Microbiology, Hanoi Medical University, Hanoi, Vietnam.

Tran Thi Quynh Nhu (TT)

Department of Microbiology, Hanoi Medical University, Hanoi, Vietnam.

Hoang Bao Long (H)

Oxford University Clinical Research Unit, Wellcome Trust Africa Asia Programme, Vietnam.

Nguyen Thi Thanh Ha (NT)

Oxford University Clinical Research Unit, Wellcome Trust Africa Asia Programme, Vietnam.

Ninh Thi Thanh Van (N)

Oxford University Clinical Research Unit, Wellcome Trust Africa Asia Programme, Vietnam.

James Campbell (J)

Oxford University Clinical Research Unit, Wellcome Trust Africa Asia Programme, Vietnam.
Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.

Ehsan Ahmadnia (E)

Department of Adult Critical Care, Guy's and St Thomas' NHS Foundation Trust, St Thomas' Hospital, London, United Kingdom.

Evelyne Kestelyn (E)

Oxford University Clinical Research Unit, Wellcome Trust Africa Asia Programme, Vietnam.
Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.

Duncan Wyncoll (D)

Department of Adult Critical Care, Guy's and St Thomas' NHS Foundation Trust, St Thomas' Hospital, London, United Kingdom.

Guy E Thwaites (GE)

Oxford University Clinical Research Unit, Wellcome Trust Africa Asia Programme, Vietnam.
Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.

Nguyen Van Hao (N)

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.

Le Thanh Chien (LT)

Department of Microbiology, Hanoi Medical University, Hanoi, Vietnam.

Nguyen Van Kinh (N)

National Hospital of Tropical Diseases, Hanoi, Vietnam.

Nguyen Van Vinh Chau (NV)

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.

H Rogier van Doorn (HR)

Oxford University Clinical Research Unit, Wellcome Trust Africa Asia Programme, Vietnam.
Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.

C Louise Thwaites (CL)

Oxford University Clinical Research Unit, Wellcome Trust Africa Asia Programme, Vietnam.
Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.

Behzad Nadjm (B)

Oxford University Clinical Research Unit, Wellcome Trust Africa Asia Programme, Vietnam.
Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.
Medical Research Council The Gambia at The London School of Hygiene & Tropical Medicine, The Gambia.

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