NCT02514655 Simple Mechanical Device to Control Pressure in the Balloon of the Endotracheal Tube to Prevent Ventilator-acquired Pneumonia
| NCT ID | NCT02514655 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Mechanical Ventilation |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2015-08-15 |
| Primary Completion | 2015-08-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2015-08-15 with a primary completion date of 2015-08-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Bruno MEGARBANE, MD, PhD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT02514655 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mechanical Ventilation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02514655 currently recruiting?
Yes, NCT02514655 is actively recruiting participants. Contact the research team at bruno.megarbane@aphp.fr for enrollment information.
Where is the NCT02514655 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT02514655 clinical trial?
NCT02514655 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Bruno MEGARBANE, MD, PhD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 500 participants.