Simple Mechanical Device to Control Pressure in the Balloon of the Endotracheal Tube to Prevent Ventilator-acquired Pneumonia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nosten® pressure control (it's not an antibiotic, but simple device), Manual pressure control.
- Who it may be relevant to
- Registry conditions: Mechanical Ventilation, Tracheal Intubation, Ventilator-acquired Pneumonia, Intubation -Related Tracheal Lesions. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Role of a Simple Mechanical Device of Pressure Control in the Balloon of the Endotracheal Tube to Prevent Ventilator-acquired Pneumonia
Overview
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.
Interventions
- 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
Primary outcome measures
- Reduction of the incidence of VAP as defined according to the criteria of the American Thoracic Society (3 months after inclusion) [Time frame: up to 3 months]
Secondary outcome measures (5)
- 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) [Time frame: up to 3 months]
- Reduction of clinically suspected Ventilator-Acquired Pneumonia (VAP) [Time frame: up to 3 months]
- Reduction in the duration of antibiotic therapy administered to patients, if diagnosed with ventilator-aquired-pneumonia (VAP) (3 months) [Time frame: 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) [Time frame: up to 3 months]
- Reduction in the significant early laryngeal and tracheal injuries related to intubation (3 months) [Time frame: up to 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
France · 1 center
- Service de Réanimation Médical et Toxicologique — Paris
Identifiers
NCT: NCT02514655 · P111113 · 2014-A00190-47