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RECRUITING
NCT02514655
NA

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2015-08-15

Completion Date

2026-12-31

Last Updated

2025-06-25

Healthy Volunteers

No

Interventions

DEVICE

Nosten® pressure control (it's not an antibiotic, but simple device)

One experimental group with the control of the cuff pressure by Nosten® device

OTHER

Manual pressure control

One control group with the manual monitoring of the cuff pressure and inflation of the balloon

Locations (1)

Service de Réanimation Médical et Toxicologique

Paris, France