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Completed

NCT Number: NCT02966392

Continuous Endotracheal Cuff Pressure Control to Prevent 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.

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Key information

Conditions

Mechanical Ventilation Complication Cross Infection Disease Attributes Healthcare-Associated Pneumonia Hospital Acquired Infection Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections Tracheal Intubation Morbidity Ventilator-associated Pneumonia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Hospital for Tropical Diseases, Hanoi, Vietnam

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tracoe cuff pressure controller

Device

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 outcomes

  1. 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 outcomes

  1. 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

  2. Clinical and microbiologically confirmed VAP (see above for definitions)

    Time frame: From randomisation to ICU discharge/death/transfer or 90 days

  3. Intubated days receiving antibiotics

    Time frame: From randomisation to ICU discharge/death/transfer or 90 days

  4. Incidence of hospital acquired infection

    Time frame: From randomisation to extubation/death/transfer/discharge/ from ICU or 90 days

  5. Total number of days ventilated/in ICU

    Time frame: From randomisation to ICU discharge, death, transfer or 90 days

  6. Cost of ICU stay

    Time frame: From ICU admission to ICU discharge, death, transfer or 90 days

  7. Cost of antibiotics in ICU stay

    Time frame: From ICU admission to ICU discharge, death, transfer or 90 days

  8. Cost of hospital stay

    Time frame: From hospital admission to hospital discharge or 90 days

  9. 28 day mortality

    Time frame: From randomisation to 28 days after randomisation

  10. 90 day mortality

    Time frame: From randomisation to 90 days after randomisation

  11. ICU mortality

    Time frame: From randomisation to discharge from ICU or death/palliative discharge from it or 90 days

  12. Hospital mortality

    Time frame: From randomisation to discharge from ICU or death/palliative discharge from it or 90 days

Other outcomes

  1. Grade 3 &4 adverse events relating to endotracheal cuff pressure

    Time frame: From randomisation to 90 days

Sponsors and collaborators

Lead sponsor

Oxford University Clinical Research Unit, Vietnam

Other

Collaborators

  • 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

Registry information

Official study title

A Randomised Controlled Trial of Continuous Endotracheal Cuff Pressure Control for the Prevention of Ventilator Associated Respiratory Infections

Acronym: VARI-prevent

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 17, 2016
Registry last updated
May 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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