Simple Mechanical Device to Control Pressure in the Balloon of the Endotracheal Tube to Prevent Ventilator-acquired Pneumonia
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Intubation -Related Tracheal Lesions
- Mechanical Ventilation
- Tracheal Intubation
- Ventilator Acquired Pneumonia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT02514655
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Bruno MEGARBANE, MD, PhD Assistance Publique - Hôpitaux de Paris