Nosten® pressure control (it's not an antibiotic, but simple device)Manual pressure control
Nosten® pressure control (it's not an antibiotic, but simple device): One experimental group with the control of the cuff pressure by Nosten® device
Manual pressure control: One control group with the manual monitoring of the cuff pressure and inflation of the balloon
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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.
Primary outcome measure(s)
Reduction of the incidence of VAP as defined according to the criteria of the American Thoracic Society (3 months after inclusion) — up to 3 months To prove that the Nosten® device is more effective than monitoring and manual inflation of the catheter balloon in reducing the occurrence of VAP.
Trial sites (1)
Facility
City
Region
Status
Service de Réanimation Médical et Toxicologique
Paris
France
Recruiting
More Assistance Publique - Hôpitaux de Paris trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.