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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Service de Réanimation Médical et Toxicologique
RECRUITING
Paris
Contact Information
Primary
Bruno MEGARBANE, MD, PhD
bruno.megarbane@aphp.fr
(+33)1 49 95 64 91
Time Frame
Start Date: 2015-08-15
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 500
Treatments
Experimental: 1: Nosten® monitoring
One experimental group with the control of the cuff pressure by Nosten® device
Active_comparator: 2: Manual monitoring
One control group with the manual monitoring of the cuff pressure and inflation of the balloon
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov