NCT02514655

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Multicenter, controlled, prospective randomized open study with blinded assessment of the primary endpoint. Two groups are set up: one experimental group with the control of the cuff pressure by the Nosten® device versus one control group with the manual monitoring of the cuff pressure and inflation of the balloon. Inclusion: All orotracheally intubated patients for an expected period \> 48 hours will be selected. Inclusion will be decided using an algorithm adapted to each center to limit the number of inclusion per month without any biases. The total number of required insclusion is 500, or 250 / group. This calculation is based on the assumption that a frequency of 25% of patients having at least one VAP in the reference strategy, ensuring a 80% power in the detection by Chi-2 test with a difference 10%. A bilateral risk of first species determined at 5% was considered.

Conditions

• Mechanical Ventilation
• Tracheal Intubation
• Ventilator-acquired Pneumonia
• Intubation -Related Tracheal Lesions

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-08-15
• Primary completion: 2015-08-15
• Completion: 2026-12-31
• First posted: 2015-08-04
• Last updated: 2025-06-25

Locations

1 site across 1 country: France