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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mechanical Ventilation, Tracheal Intubation, Ventilator-acquired Pneumonia, Intubation -Related Tracheal Lesions

Intervention / Treatment
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* Device: Nosten® pressure control (it's not an antibiotic, but simple device)
* Other: Manual pressure control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1: Nosten® monitoring<br>One experimental group with the control of the cuff pressure by Nosten® device | Device: Nosten® pressure control (it's not an antibiotic, but simple device)<br>* One experimental group with the control of the cuff pressure by Nosten® device<br>|
| Active Comparator: 2: Manual monitoring<br>One control group with the manual monitoring of the cuff pressure and inflation of the balloon | Other: Manual pressure control<br>* One control group with the manual monitoring of the cuff pressure and inflation of the balloon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of the incidence of VAP as defined according to the criteria of the American Thoracic Society (3 months after inclusion) | To prove that the Nosten® device is more effective than monitoring and manual inflation of the catheter balloon in reducing the occurrence of VAP. | up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the tracheobronchial bacterial colonization assessed using the bacteriological examination of the tracheal aspiration (as long as the patient is intubated during 3 months after inclusion) | using the bacteriological examination of the tracheal aspiration during the intensive care hospitalization | up to 3 months | 
| Reduction of clinically suspected Ventilator-Acquired Pneumonia (VAP) | before obtaining microbiological results needed to affirm the Ventilator-Acquired Pneumonia (VAP) according to the criteria of the American Thoracic Society (3 months) | up to 3 months | 
| Reduction in the duration of antibiotic therapy administered to patients, if diagnosed with ventilator-aquired-pneumonia (VAP) (3 months) | Reduction of clinically suspected Ventilator-Acquired Pneumonia (VAP) | up to 3 months | 
| Reduction in the periods of hyper-pressure and under-inflation (as long as the patient is intubated during 3 months after inclusion) | Using Nosten® device | up to 3 months | 
| Reduction in the significant early laryngeal and tracheal injuries related to intubation (3 months) | using the tracheal ischemia score [Touat L. Intensive Care Med 2014] | up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tracheal intubation, Cuff pressure, Ventilator-acquired pneumonia, Intensive care unit, Tracheal injuries