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Clinical Trials in France / NCT02514655
Recruiting Not applicable

Simple Mechanical Device to Control Pressure in the Balloon of the Endotracheal Tube to Prevent Ventilator-acquired Pneumonia

NCT02514655 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2015-08-15
Last updated
2025-06-25

Condition(s) studied

Mechanical VentilationTracheal IntubationVentilator-acquired PneumoniaIntubation -Related Tracheal Lesions

Investigational drug(s) / intervention(s)

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)

Trial sites (1)

FacilityCityRegionStatus
Service de Réanimation Médical et Toxicologique Paris France Recruiting

More Assistance Publique - Hôpitaux de Paris trials in France

Other trials for the same condition

Official registry record

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.

View NCT02514655 on ClinicalTrials.gov ↗ ← All trials in France