Continuous Endotracheal Cuff Pressure Control to Prevent Ventilator Associated Respiratory Infections
- Conditions
- Tracheal Intubation MorbidityHospital Acquired InfectionVentilator-Associated PneumoniaMechanical Ventilation Complication
- Interventions
- Device: Tracoe cuff pressure controller
- Registration Number
- NCT02966392
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
- About to be intubated or intubated for ≤ 24 hours (either oral or tracheostomy)
- For active treatment
- previously enrolled in this study
- previously intubated within 14 days
- suffering from known tracheomalacia, tracheal stenosis or stridor relating to tracheal injury
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Continuous Pressure Control (CPC) Tracoe cuff pressure controller Continuous endotracheal cuff pressure control using Tracoe cuff pressure controller during their intubated stay on ICU.
- Primary Outcome Measures
Name Time Method Ventilator Associated Respiratory Infection (VARI) - defined as Ventilator Associated Pneumonia (VAP) or Ventilator Associated Tracheobronchitis (VAT) From randomisation to ICU discharge/death/transfer or 90 days
- Secondary Outcome Measures
Name Time Method Incidence of hospital acquired infection From randomisation to extubation/death/transfer/discharge/ from ICU or 90 days Intubated days receiving antibiotics From randomisation to ICU discharge/death/transfer or 90 days ICU mortality From randomisation to discharge from ICU or death/palliative discharge from it or 90 days Hospital mortality From randomisation to discharge from ICU or death/palliative discharge from it 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 From randomisation to ICU discharge/death/transfer or 90 days Cost of ICU stay From ICU admission to ICU discharge, death, transfer or 90 days Cost of antibiotics in ICU stay From ICU admission to ICU discharge, death, transfer or 90 days Cost of hospital stay From hospital admission to hospital discharge or 90 days 28 day mortality From randomisation to 28 days after randomisation Clinical and microbiologically confirmed VAP (see above for definitions) From randomisation to ICU discharge/death/transfer or 90 days Total number of days ventilated/in ICU From randomisation to ICU discharge, death, transfer or 90 days 90 day mortality From randomisation to 90 days after randomisation
Trial Locations
- Locations (3)
National Hospital for Tropical Diseases
🇻🇳Hanoi, Vietnam
Hospital for Tropical Diseases
🇻🇳Ho Chi Minh City, Vietnam
Trung Vuong Hospital
🇻🇳Ho Chi Minh City, Vietnam