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

• ClinicalTrials.gov Identifier: NCT02966392
• Recruitment Status: Completed
• First Posted: November 17, 2016
• Last Update Posted: May 29, 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
• Information provided by (Responsible Party): Oxford University Clinical Research Unit, Vietnam

Tracking Information

• First Submitted Date: November 9, 2016
• First Posted Date: November 17, 2016
• Last Update Posted Date: May 29, 2020
• Actual Study Start Date: November 1, 2016
• Actual Primary Completion Date: March 7, 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 18, 2017): 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 ]
• Original Primary Outcome Measures (submitted: November 14, 2016): Ventilator Associated Respiratory Infection (VARI) - defined as Ventilator Associated Pneumonia (VAP) or Ventilator Associated Tracheobronchitis (VAT) [ Time Frame: During ICU stay, average 12 days ]

Current Secondary Outcome Measures (submitted: September 18, 2017)

• 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 ]
• Clinical and microbiologically confirmed VAP (see above for definitions) [ Time Frame: From randomisation to ICU discharge/death/transfer or 90 days ]
• Intubated days receiving antibiotics [ Time Frame: From randomisation to ICU discharge/death/transfer or 90 days ]
• Incidence of hospital acquired infection [ Time Frame: From randomisation to extubation/death/transfer/discharge/ from ICU or 90 days ]
• Total number of days ventilated/in ICU [ Time Frame: From randomisation to ICU discharge, death, transfer or 90 days ]
• Cost of ICU stay [ Time Frame: From ICU admission to ICU discharge, death, transfer or 90 days ]
• Cost of antibiotics in ICU stay [ Time Frame: From ICU admission to ICU discharge, death, transfer or 90 days ]
• Cost of hospital stay [ Time Frame: From hospital admission to hospital discharge or 90 days ]
• 28 day mortality [ Time Frame: From randomisation to 28 days after randomisation ]
• 90 day mortality [ Time Frame: From randomisation to 90 days after randomisation ]
• ICU mortality [ Time Frame: From randomisation to discharge from ICU or death/palliative discharge from it or 90 days ]
• Hospital mortality [ Time Frame: From randomisation to discharge from ICU or death/palliative discharge from it or 90 days ]

Original Secondary Outcome Measures (submitted: November 14, 2016)

• 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: During ICU stay, average 12 days ]
• Intubated days receiving antibiotics [ Time Frame: During ICU stay, average 12 days ]
• Clinical and microbiologically confirmed VAP (see above for definitions) [ Time Frame: During ICU stay, average 12 days ]
• Development of other hospital acquired infection [ Time Frame: During ICU stay, average 12 days ]
• Total number of days ventilated/in ICU [ Time Frame: During hospital stay, average 16 days ]
• Cost of ICU/hospital stay + cost of antibiotics during ICU/hospital stay [ Time Frame: During hospital stay, average 16 days ]
• Mortality [ Time Frame: In ICU (average 12 days), in hospital (average 16 days) and at 28 and 90 days post enrolment ]

• Current Other Pre-specified Outcome Measures (submitted: September 18, 2017): Grade 3 &4 adverse events relating to endotracheal cuff pressure [ Time Frame: From randomisation to 90 days ]
• Original Other Pre-specified Outcome Measures (submitted: November 14, 2016): Grade 3 &4 adverse events relating to endotracheal cuff pressure [ Time Frame: Up to 90 days post enrollment or hospital discharge which ever is later ]

Descriptive Information

• Brief Title: Continuous Endotracheal Cuff Pressure Control to Prevent Ventilator Associated Respiratory Infections
• Official Title: A Randomised Controlled Trial of Continuous Endotracheal Cuff Pressure Control for the Prevention of Ventilator Associated Respiratory Infections
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention

Condition

• Mechanical Ventilation Complication
• Tracheal Intubation Morbidity
• Ventilator-Associated Pneumonia
• Hospital Acquired Infection

Intervention

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.

Study Arms

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

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 14, 2016): 600
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 2019
• Actual Primary Completion Date: March 7, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Vietnam

Administrative Information

• NCT Number: NCT02966392
• Other Study ID Numbers: 16HN
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

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

• Current Responsible Party: Oxford University Clinical Research Unit, Vietnam
• Original Responsible Party: Same as current
• Current Study Sponsor: Oxford University Clinical Research Unit, Vietnam
• Original Study Sponsor: Same as current

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

• PRS Account: Oxford University Clinical Research Unit, Vietnam
• Verification Date: May 2020