NCT02966392

Continuous Endotracheal Cuff Pressure Control to Prevent Ventilator Associated Respiratory Infections

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Oxford University Clinical Research Unit, Vietnam · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-03-07
• Completion: 2019-09-01
• First posted: 2016-11-17
• Last updated: 2020-05-29

Locations

3 sites across 1 country: Vietnam