Device to Control Pressure in Endotracheal Tube Balloons to Prevent Pneumonia
Role of a Simple Mechanical Device of Pressure Control in the Balloon of the Endotracheal Tube to Prevent Ventilator-acquired Pneumonia
This study is testing a new device that helps control the pressure in breathing tubes to see if it can lower the chances of patients getting pneumonia while on a ventilator.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT02514655 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the Nosten® device in controlling the pressure of the balloon in endotracheal tubes compared to manual monitoring. The study involves a multicenter, controlled, prospective randomized design with blinded assessment of outcomes. Patients who are orotracheally intubated for more than 48 hours will be randomly assigned to either the experimental group using the Nosten® device or a control group receiving standard manual pressure monitoring. The primary goal is to determine if the device can reduce the incidence of ventilator-acquired pneumonia and related complications.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are mechanically ventilated and intubated for more than 48 hours in an ICU setting.
Not a fit: Patients who may not benefit include those with nasotracheal intubation, tracheotomy prior to admission, or those with certain traumatic injuries or terminal illnesses.
Why it matters
Potential benefit: If successful, this device could significantly reduce the risk of ventilator-acquired pneumonia and improve patient comfort and outcomes in mechanically ventilated patients.
How similar studies have performed: Other studies have explored similar approaches to managing cuff pressure in intubated patients, but the specific use of the Nosten® device represents a novel intervention.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Paris
- Service de Réanimation Médical et Toxicologique — Paris, France (Recruiting)
Study contacts
- Principal investigator: Bruno MEGARBANE, MD, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Bruno MEGARBANE, MD, PhD
- Email: bruno.megarbane@aphp.fr
- Phone: (+33)1 49 95 64 91
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.