Continuous Endotracheal Cuff Pressure Control to Prevent Ventilator Associated Respiratory Infections

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02966392
• Date of registration: 09/11/2016
• Prospective Registration: No
• Primary sponsor: Oxford University Clinical Research Unit, Vietnam
• Public title: Continuous Endotracheal Cuff Pressure Control to Prevent Ventilator Associated Respiratory Infections VARI-prevent
• Scientific title: A Randomised Controlled Trial of Continuous Endotracheal Cuff Pressure Control for the Prevention of Ventilator Associated Respiratory Infections
• Date of first enrolment: November 1, 2016
• Target sample size: 600
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02966392
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Vietnam

Contacts

• Name: Behzad Nadjm, MBChB MD
• Affiliation: Oxford University Clinical Research Unit

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hospital Acquired Infection

Tracheal Intubation Morbidity

Ventilator-Associated Pneumonia

Mechanical Ventilation Complication

Intervention(s)

Device: Tracoe cuff pressure controller

Primary Outcome(s)

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(s)

Hospital mortality [Time Frame: From randomisation to discharge from ICU or death/palliative discharge from it or 90 days]

ICU mortality [Time Frame: From randomisation to discharge from ICU or death/palliative discharge from it or 90 days]

28 day mortality [Time Frame: From randomisation to 28 days after randomisation]

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]

90 day mortality [Time Frame: From randomisation to 90 days after randomisation]

Cost of hospital stay [Time Frame: From hospital admission to hospital discharge 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]

Clinical and microbiologically confirmed VAP (see above for definitions) [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]

Intubated days receiving antibiotics [Time Frame: From randomisation to ICU discharge/death/transfer or 90 days]

Secondary ID(s)

16HN

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

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

The National Hospital for Tropical Diseases, Ha Noi, Vietnam

Trung Vuong Hospital, Ho Chi Minh City, Vietnam