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Continuous Endotracheal Cuff Pressure Control to Prevent Ventilator Associated Respiratory Infections (VARI-prevent)

Primary Purpose

Mechanical Ventilation Complication, Tracheal Intubation Morbidity, Ventilator-Associated Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Tracoe cuff pressure controller
Sponsored by
Oxford University Clinical Research Unit, Vietnam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mechanical Ventilation Complication focused on measuring Cuff pressure, Ventilator associated pneumonia, Respiratory tract infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Hospital for Tropical Diseases
  • Hospital for Tropical Diseases
  • Trung Vuong Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Continuous Pressure Control (CPC)

Standard Care

Arm Description

Continuous endotracheal cuff pressure control using Tracoe cuff pressure controller during their intubated stay on ICU.

Intermittent cuff pressure control through manual measurement performed 3 times per day (standard care)

Outcomes

Primary Outcome Measures

Ventilator Associated Respiratory Infection (VARI) - defined as Ventilator Associated Pneumonia (VAP) or Ventilator Associated Tracheobronchitis (VAT)

Secondary Outcome Measures

Microbiologically confirmed VARI defined as above plus bacterial growth of ≥105 cfu/ml (ETA) or equivalent semi-quantitative for both VAP and VAT
Clinical and microbiologically confirmed VAP (see above for definitions)
Intubated days receiving antibiotics
Incidence of hospital acquired infection
Total number of days ventilated/in ICU
Cost of ICU stay
Cost of antibiotics in ICU stay
Cost of hospital stay
28 day mortality
90 day mortality
ICU mortality
Hospital mortality

Full Information

First Posted
November 9, 2016
Last Updated
May 28, 2020
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
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1. Study Identification

Unique Protocol Identification Number
NCT02966392
Brief Title
Continuous Endotracheal Cuff Pressure Control to Prevent Ventilator Associated Respiratory Infections
Acronym
VARI-prevent
Official Title
A Randomised Controlled Trial of Continuous Endotracheal Cuff Pressure Control for the Prevention of Ventilator Associated Respiratory Infections
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
March 7, 2019 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation Complication, Tracheal Intubation Morbidity, Ventilator-Associated Pneumonia, Hospital Acquired Infection
Keywords
Cuff pressure, Ventilator associated pneumonia, Respiratory tract infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous Pressure Control (CPC)
Arm Type
Experimental
Arm Description
Continuous endotracheal cuff pressure control using Tracoe cuff pressure controller during their intubated stay on ICU.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Intermittent cuff pressure control through manual measurement performed 3 times per day (standard care)
Intervention Type
Device
Intervention Name(s)
Tracoe cuff pressure controller
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ventilator Associated Respiratory Infection (VARI) - defined as Ventilator Associated Pneumonia (VAP) or Ventilator Associated Tracheobronchitis (VAT)
Time Frame
From randomisation to ICU discharge/death/transfer or 90 days
Secondary Outcome Measure Information:
Title
Microbiologically confirmed VARI defined as above plus bacterial growth of ≥105 cfu/ml (ETA) or equivalent semi-quantitative for both VAP and VAT
Time Frame
From randomisation to ICU discharge/death/transfer or 90 days
Title
Clinical and microbiologically confirmed VAP (see above for definitions)
Time Frame
From randomisation to ICU discharge/death/transfer or 90 days
Title
Intubated days receiving antibiotics
Time Frame
From randomisation to ICU discharge/death/transfer or 90 days
Title
Incidence of hospital acquired infection
Time Frame
From randomisation to extubation/death/transfer/discharge/ from ICU or 90 days
Title
Total number of days ventilated/in ICU
Time Frame
From randomisation to ICU discharge, death, transfer or 90 days
Title
Cost of ICU stay
Time Frame
From ICU admission to ICU discharge, death, transfer or 90 days
Title
Cost of antibiotics in ICU stay
Time Frame
From ICU admission to ICU discharge, death, transfer or 90 days
Title
Cost of hospital stay
Time Frame
From hospital admission to hospital discharge or 90 days
Title
28 day mortality
Time Frame
From randomisation to 28 days after randomisation
Title
90 day mortality
Time Frame
From randomisation to 90 days after randomisation
Title
ICU mortality
Time Frame
From randomisation to discharge from ICU or death/palliative discharge from it or 90 days
Title
Hospital mortality
Time Frame
From randomisation to discharge from ICU or death/palliative discharge from it or 90 days
Other Pre-specified Outcome Measures:
Title
Grade 3 &4 adverse events relating to endotracheal cuff pressure
Time Frame
From randomisation to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Behzad Nadjm, MBChB MD
Organizational Affiliation
Oxford University Clinical Research Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Hospital for Tropical Diseases
City
Hanoi
Country
Vietnam
Facility Name
Hospital for Tropical Diseases
City
Ho Chi Minh City
Country
Vietnam
Facility Name
Trung Vuong Hospital
City
Ho Chi Minh City
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We hope to share IPD, however the framework to do so is not yet finalised with our collaborating institutions
Citations:
PubMed Identifier
34420048
Citation
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.
Results Reference
derived
PubMed Identifier
29615093
Citation
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.
Results Reference
derived

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Continuous Endotracheal Cuff Pressure Control to Prevent Ventilator Associated Respiratory Infections

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