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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jul 30, 2015

Keywords

ClinConnect Summary

This clinical trial is investigating a new device called the Nosten® that helps control the pressure in the balloon of a breathing tube (tracheal tube) for patients on mechanical ventilation. The goal is to see if this device can prevent complications like ventilator-acquired pneumonia (a type of lung infection) and early damage to the trachea, which often happens when a breathing tube is used for a long time. The researchers believe that using the Nosten® device will be more effective than the current method of checking and manually adjusting the balloon pressure, ultimately leading to less discomfort for patients and easier care for nurses.

To be eligible for this trial, participants must be adults aged 18 or older who are in the intensive care unit (ICU) and need mechanical ventilation. They should have had a breathing tube placed through their mouth and expect to be on the ventilator for more than 48 hours. Certain patients, such as those with specific medical conditions or injuries, may not qualify. If enrolled, participants will be monitored while using the Nosten® device, and the research team will track any differences in their health outcomes compared to those who receive standard care. This study aims to improve the safety and comfort of patients requiring prolonged respiratory support.

Gender

ALL

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.