Simple Mechanical Device to Control Pressure in the Balloon of the Endotracheal Tube to Prevent Ventilator-acquired Pneumonia
Role of a Simple Mechanical Device of Pressure Control in the Balloon of the Endotracheal Tube to Prevent Ventilator-acquired Pneumonia
Assistance Publique - Hôpitaux de Paris
500 participants
Aug 15, 2015
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria3
- 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
Exclusion Criteria13
- 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
- Moribund patients (terminal illness or care-limiting decision)
- Minors protected or incapacitated patients
- Patients with recently diagnosed ENT cancer
- Patients with facial, thoracic, spinal or upper airway trauma
- Patients burned, intoxicated by fire fumes or caustic ingestion
- Patient pregnant or breastfeeding (or with known positive urine pregnancy test before inclusion)
- Patient intubated with a subglottic suction tube
- Unaffiliated patients to a social security
- Patients included in any other scientific study that may interfere with the outcome criteria of this study. This includes any other study on tracheal intubation or mechanical ventilation, if the use of the pressure control device may interfere with its endpoint.
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Interventions
One experimental group with the control of the cuff pressure by Nosten® device
One control group with the manual monitoring of the cuff pressure and inflation of the balloon
Locations(1)
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NCT02514655