Device to Control Pressure in Endotracheal Tube Balloons to Prevent Pneumonia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.