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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
600
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.
National Hospital for Tropical Diseases
Hanoi, Vietnam
Hospital for Tropical Diseases
Ho Chi Minh City, Vietnam
Trung Vuong Hospital
Ho Chi Minh City, Vietnam
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
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
Clinical and microbiologically confirmed VAP (see above for definitions)
Time frame: From randomisation to ICU discharge/death/transfer or 90 days
Intubated days receiving antibiotics
Time frame: From randomisation to ICU discharge/death/transfer 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
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
Cost of hospital stay
Time frame: From hospital admission to hospital discharge or 90 days
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28 day mortality
Time frame: From randomisation to 28 days after randomisation
90 day mortality
Time frame: From randomisation to 90 days after randomisation
ICU mortality
Time frame: From randomisation to discharge from ICU or death/palliative discharge from it or 90 days
Hospital mortality
Time frame: From randomisation to discharge from ICU or death/palliative discharge from it or 90 days