Informations générales (source: ClinicalTrials.gov)
Role of a Simple Mechanical Device of Pressure Control in the Balloon of the Endotracheal Tube to Prevent Ventilator-acquired Pneumonia
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
août 2015
décembre 2026
18 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CH DE VERSAILLES SITE ANDRE MIGNOT | MEGARBANE Bruno | 01/11/2025 08:08:39 | Contacter | ||
| CH SUD ESSONNE-DOURDAN-ETAMPES | MEGARBANE Bruno | 01/11/2025 08:08:39 | Contacter | ||
| GHU PARIS PSY ET NEUROSCIENCES | MEGARBANE Bruno | 01/11/2025 08:08:38 | Contacter | ||
| HOPITAL FONDATION A. DE ROTHSCHILD | MEGARBANE Bruno | 01/11/2025 08:08:38 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 01/11/2025 08:08:41 | Contacter | |||
| AP-HP - Hôpital Antoine Béclère | |||||
| AP-HP - Hôpital Avicenne | |||||
| AP-HP - Hôpital Bicêtre | |||||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | |||||
| AP-HP - Hôpital Louis Mourier | |||||
| AP-HP - Hôpital Raymond Poincaré | |||||
| AP-HP - Hôpital Saint Louis | |||||
| AP-HP - Hôpital Tenon | |||||
Critères
Tous
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
- 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
- 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.