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

Oxford University Clinical Research Unit, Vietnam

Status: Completed

Conditions: Hospital Acquired Infection; Ventilator-Associated Pneumonia; Mechanical Ventilation Complication; Tracheal Intubation Morbidity

Treatments: Device: Tracoe cuff pressure controller

Study type: Interventional

Funder types: Other

Identifiers

NCT02966392

16HN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 2 patient groups

Continuous Pressure Control (CPC)

Experimental group

Description:

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

Treatment:

Device: Tracoe cuff pressure controller

Standard Care

No Intervention group

Description:

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