Actively Recruiting
Simple Mechanical Device to Control Pressure in the Balloon of the Endotracheal Tube to Prevent Ventilator-acquired Pneumonia
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-06-25
500
Participants Needed
1
Research Sites
593 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Simple Mechanical Device to Control Pressure in the Balloon of the Endotracheal Tube to Prevent Ventilator-acquired Pneumonia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 6518 years
- Patients admitted in the ICU, mechanically ventilated and intubated orally with standard polyvinyl chloride "high-volume low pressure" tubes
- Intubation decided by physician for respiratory, neurological, and/or hemodynamic failure
- Expected mechanical ventilation duration greater than 48 hours
You will not qualify if you...
- Patients intubated by nasotracheal route
- Patients with tracheotomy before admission
- Patients intubated with polyurethane or conical shaped polyvinyl chloride balloon catheters
- Patients intubated for more than 48 hours before possible recruitment
- Moribund patients or those with care-limiting decisions
- Minors protected or incapacitated patients
- Patients with recently diagnosed ENT cancer
- Patients with facial, thoracic, spinal, or upper airway trauma
- Patients burned or intoxicated by fire fumes or caustic ingestion
- Pregnant or breastfeeding patients or those with positive pregnancy test before inclusion
- Patients intubated with a subglottic suction tube
- Patients not affiliated to social security
- Patients included in other scientific studies that may interfere with outcomes, especially related to intubation or ventilation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Service de Réanimation Médical et Toxicologique
Paris, France, 75010
Actively Recruiting
Research Team
B
Bruno MEGARBANE, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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