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

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Tracheal Intubation; Intubation -Related Tracheal Lesions; Ventilator-acquired Pneumonia; Mechanical Ventilation

Treatments: Other: Manual pressure control; Device: Nosten® pressure control (it's not an antibiotic, but simple device)

Study type: Interventional

Funder types: Other

Identifiers

NCT02514655

2014-A00190-47 (Other Identifier)

P111113

Details and patient eligibility

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged ≥18 years
• Patients admitted in the ICU, mechanically ventilated and whose trachea was intubated by the oral route using tubes with catheter polyvinyl chloride "high-volume low pressure" and of standard shape tubes Intubation indication is decided by the physicians in charge according to the usual criteria of respiratory, neurological and /or hemodynamic failure
• With an expected duration of mechanical ventilation > 48 hours

Exclusion criteria

• Patients intubated by nasotracheal route
• Patients with tracheotomy before admission
• Patients intubated with a polyurethane balloon catheter or a polyvinyl chloride balloon catheter of conical shape
• Previously intubated patients for > 48 hours before their possible recruitment
• Moribund patients (terminal illness or care-limiting decision)
• Minors protected or incapacitated patients
• Patients with recently diagnosed ENT cancer
• Patients with facial, thoracic, spinal or upper airway trauma
• Patients burned, intoxicated by fire fumes or caustic ingestion
• Patient pregnant or breastfeeding (or with known positive urine pregnancy test before inclusion)
• Patient intubated with a subglottic suction tube
• Unaffiliated patients to a social security
• Patients included in any other scientific study that may interfere with the outcome criteria of this study. This includes any other study on tracheal intubation or mechanical ventilation, if the use of the pressure control device may interfere with its endpoint.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

1: Nosten® monitoring

Experimental group

Description:

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

Treatment:

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

2: Manual monitoring

Active Comparator group

Description:

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

Treatment:

Other: Manual pressure control