RecruitingNot ApplicableNCT02514655

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

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

500 participants

Start Date

Aug 15, 2015

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Manual pressure control and Nosten® pressure control (it's not an antibiotic, but simple device) for people with intubation -related tracheal lesions, mechanical ventilation, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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

OTHERManual 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

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NCT02514655


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