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A Randomised Controlled Trial of Continuous Endotracheal Cuff Pressure Control for the Prevention of 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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
National Hospital for Tropical Diseases
Hanoi, Vietnam
Hospital for Tropical Diseases
Ho Chi Minh City, Vietnam
Trung Vuong Hospital
Ho Chi Minh City, Vietnam
Start Date
November 1, 2016
Primary Completion Date
March 7, 2019
Completion Date
September 1, 2019
Last Updated
May 29, 2020
600
ACTUAL participants
Tracoe cuff pressure controller
DEVICE
Lead Sponsor
Oxford University Clinical Research Unit, Vietnam
Collaborators
NCT07013032
NCT07207772
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06971042