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

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.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation Complication; Tracheal Intubation Morbidity; Ventilator-Associated Pneumonia; Hospital Acquired Infection
• Intervention / Treatment: Device: Tracoe cuff pressure controller

Detailed Description

The proposed study is a randomized controlled trial of tracheal cuff pressure control using continuous control via an automated electronic device as compared with intermittent pressure control for the prevention of ventilator associated respiratory infection in ICU.

The study will be conducted at multiple sites in Vietnam. Recruitment will be for 18 months at all centers. Patients experiencing any hospital acquired infection whilst at risk of Ventilator Associated Respiratory Infections will be evaluated in using a standardised investigation protocol to identify cases of VARI and other hospital acquired infections (HAI)s. Assessment of VARI will be based on published criteria and carried out by an endpoint review committee independent of patient care and blinded to the allocation of the patient. Antibiotic use data and duration of stay will be important secondary outcome measures.

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam
    • National Hospital for Tropical Diseases
  • Ho Chi Minh City, Vietnam
    • Hospital for Tropical Diseases
  • Ho Chi Minh City, Vietnam
    • Trung Vuong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• About to be intubated or intubated for ≤ 24 hours (either oral or tracheostomy)
• For active treatment

Exclusion Criteria:

• previously enrolled in this study
• previously intubated within 14 days
• suffering from known tracheomalacia, tracheal stenosis or stridor relating to tracheal injury

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous Pressure Control (CPC); Continuous endotracheal cuff pressure control using Tracoe cuff pressure controller during their intubated stay on ICU.	Device: Tracoe cuff pressure controller; 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.
No Intervention: Standard Care; Intermittent cuff pressure control through manual measurement performed 3 times per day (standard care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Cost of ICU stay	From ICU admission to ICU discharge, death, transfer or 90 days
Cost of antibiotics in ICU stay	From ICU admission to ICU discharge, death, transfer or 90 days
Cost of hospital stay	From hospital admission to hospital discharge or 90 days
28 day mortality	From randomisation to 28 days after randomisation
90 day mortality	From randomisation to 90 days after randomisation
ICU mortality	From randomisation to discharge from ICU or death/palliative discharge from it or 90 days
Hospital mortality	From randomisation to discharge from ICU or death/palliative discharge from it or 90 days

Other Outcome Measures

Outcome Measure	Time Frame
Grade 3 &4 adverse events relating to endotracheal cuff pressure	From randomisation to 90 days

Collaborators and Investigators

• Sponsor: Oxford University Clinical Research Unit, Vietnam
• Collaborators: The Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam; Trung Vuong Hospital, Ho Chi Minh City, Vietnam; The National Hospital for Tropical Diseases, Ha Noi, Vietnam
• Investigators: Principal Investigator: Behzad Nadjm, MBChB MD, Oxford University Clinical Research Unit

Publications and helpful links

General Publications

• 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.
• Dat 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): March 7, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: November 9, 2016
• First Submitted That Met QC Criteria: November 14, 2016
• First Posted (Estimate): November 17, 2016

Study Record Updates

• Last Update Posted (Actual): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Ventilator associated pneumonia; Cuff pressure; Respiratory tract infections
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Infections; Communicable Diseases; Pneumonia; Respiratory Tract Infections; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: 16HN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: We hope to share IPD, however the framework to do so is not yet finalised with our collaborating institutions