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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Nosten® pressure control (it's not an antibiotic, but simple device)
  • Manual pressure control

Treatment groups

500 Participants
are divided into 2 treatment groups