About this trial
Hypothesis: Nosten® device is able to reduce the time of underinflated balloon and removes excess pressure. This device may thus reduce the risk of ventilator-acquired pneumonia (VAP) and early tracheal lesions resulting from intubation with decreased discomfort, morbidity, and nursing workload.
The main objective of the investigators is to show that Nosten® device is more effective than monitoring and manual inflation of the balloon of the tracheal tube to prevent VAP occurrence.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged ≥18 years
Patients admitted in the ICU, mechanically ventilated and whose trachea was intubated by the oral route using tubes with catheter polyvinyl chloride "high-volume low pressure" and of standard shape tubes Intubation indication is decided by the physicians in charge according to the usual criteria of respiratory, neurological and /or hemodynamic failure
With an expected duration of mechanical ventilation > 48 hours
Disqualifiers
Patients intubated by nasotracheal route
Patients with tracheotomy before admission
Patients intubated with a polyurethane balloon catheter or a polyvinyl chloride balloon catheter of conical shape
Previously intubated patients for > 48 hours before their possible recruitment
Trial design
Parallel
Treatments tested in this trial
Nosten® pressure control (it's not an antibiotic, but simple device)
DeviceOne experimental group with the control of the cuff pressure by Nosten® device
Manual pressure control
Other interventionOne control group with the manual monitoring of the cuff pressure and inflation of the balloon
Treatment groups
Trial outcomes
Primary outcomes
Reduction of the incidence of VAP as defined according to the criteria of the American Thoracic Society (3 months after inclusion)
To prove that the Nosten® device is more effective than monitoring and manual inflation of the catheter balloon in reducing the occurrence of VAP.
Secondary outcomes
Reduction in the tracheobronchial bacterial colonization assessed using the bacteriological examination of the tracheal aspiration (as long as the patient is intubated during 3 months after inclusion)
using the bacteriological examination of the tracheal aspiration during the intensive care hospitalization
Reduction of clinically suspected Ventilator-Acquired Pneumonia (VAP)
before obtaining microbiological results needed to affirm the Ventilator-Acquired Pneumonia (VAP) according to the criteria of the American Thoracic Society (3 months)
Reduction in the duration of antibiotic therapy administered to patients, if diagnosed with ventilator-aquired-pneumonia (VAP) (3 months)
Reduction of clinically suspected Ventilator-Acquired Pneumonia (VAP)
Reduction in the periods of hyper-pressure and under-inflation (as long as the patient is intubated during 3 months after inclusion)
Using Nosten® device
Sponsors and contacts
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