Continuous Endotracheal Cuff Pressure Control to Prevent Ventilator Associated Respiratory Infections
VARI-prevent
A Randomised Controlled Trial of Continuous Endotracheal Cuff Pressure Control for the Prevention of Ventilator Associated Respiratory Infections
1 other identifier
interventional
600
1 country
3
Brief Summary
The purpose of the study is to determine whether automated cuff pressure control results in a reduction in the proportion of patients developing ventilator associated respiratory infections during their stay in intensive care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2016
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 9, 2016
CompletedFirst Posted
Study publicly available on registry
November 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedMay 29, 2020
May 1, 2020
2.3 years
November 9, 2016
May 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ventilator Associated Respiratory Infection (VARI) - defined as Ventilator Associated Pneumonia (VAP) or Ventilator Associated Tracheobronchitis (VAT)
From randomisation to ICU discharge/death/transfer or 90 days
Secondary Outcomes (12)
Microbiologically confirmed VARI defined as above plus bacterial growth of ≥105 cfu/ml (ETA) or equivalent semi-quantitative for both VAP and VAT
From randomisation to ICU discharge/death/transfer or 90 days
Clinical and microbiologically confirmed VAP (see above for definitions)
From randomisation to ICU discharge/death/transfer or 90 days
Intubated days receiving antibiotics
From randomisation to ICU discharge/death/transfer or 90 days
Incidence of hospital acquired infection
From randomisation to extubation/death/transfer/discharge/ from ICU or 90 days
Total number of days ventilated/in ICU
From randomisation to ICU discharge, death, transfer or 90 days
- +7 more secondary outcomes
Other Outcomes (1)
Grade 3 &4 adverse events relating to endotracheal cuff pressure
From randomisation to 90 days
Study Arms (2)
Continuous Pressure Control (CPC)
EXPERIMENTALContinuous endotracheal cuff pressure control using Tracoe cuff pressure controller during their intubated stay on ICU.
Standard Care
NO INTERVENTIONIntermittent cuff pressure control through manual measurement performed 3 times per day (standard care)
Interventions
Participant will be attached to the cuff pressure controller as soon as possible after enrolment. They will remain attached during their intubated stay. If reintubated during same admission they will continue in the intervention arm. If readmitted to ICU they will be managed according to standard care.
Eligibility Criteria
You may qualify if:
- About to be intubated or intubated for ≤ 24 hours (either oral or tracheostomy)
- For active treatment
You may not qualify if:
- previously enrolled in this study
- previously intubated within 14 days
- suffering from known tracheomalacia, tracheal stenosis or stridor relating to tracheal injury
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
National Hospital for Tropical Diseases
Hanoi, Vietnam
Hospital for Tropical Diseases
Ho Chi Minh City, Vietnam
Trung Vuong Hospital
Ho Chi Minh City, Vietnam
Related Publications (2)
Dat VQ, Minh Yen L, Thi Loan H, Dinh Phu V, Thien Binh N, Geskus RB, Khanh Trinh DH, Hoang Mai NT, Hoan Phu N, Huong Lan NP, Phuong Thuy T, Vu Trung N, Trung Cap N, Tuyet Trinh D, Thi Hoa N, Thi Thu Van N, Luan VTT, Quynh Nhu TT, Bao Long H, Thanh Ha NT, Thi Thanh Van N, Campbell J, Ahmadnia E, Kestelyn E, Wyncoll D, Thwaites GE, Van Hao N, Chien LT, Van Kinh N, Vinh Chau NV, van Doorn HR, Thwaites CL, Nadjm B. Effectiveness of Continuous Endotracheal Cuff Pressure Control for the Prevention of Ventilator-Associated Respiratory Infections: An Open-Label Randomized, Controlled Trial. Clin Infect Dis. 2022 May 30;74(10):1795-1803. doi: 10.1093/cid/ciab724.
PMID: 34420048DERIVEDDat VQ, Geskus RB, Wolbers M, Loan HT, Yen LM, Binh NT, Chien LT, Mai NTH, Phu NH, Lan NPH, Hao NV, Long HB, Thuy TP, Kinh NV, Trung NV, Phu VD, Cap NT, Trinh DT, Campbell J, Kestelyn E, Wertheim HFL, Wyncoll D, Thwaites GE, van Doorn HR, Thwaites CL, Nadjm B. Continuous versus intermittent endotracheal cuff pressure control for the prevention of ventilator-associated respiratory infections in Vietnam: study protocol for a randomised controlled trial. Trials. 2018 Apr 4;19(1):217. doi: 10.1186/s13063-018-2587-6.
PMID: 29615093DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Behzad Nadjm, MBChB MD
Oxford University Clinical Research Unit
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2016
First Posted
November 17, 2016
Study Start
November 1, 2016
Primary Completion
March 7, 2019
Study Completion
September 1, 2019
Last Updated
May 29, 2020
Record last verified: 2020-05