Status:
COMPLETED
Cuff Pressure Control and Evacuation of Subglottic Secretions To Prevent Pneumonia
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborating Sponsors:
Catholic University of the Sacred Heart
Conditions:
Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Multicenter, cluster randomized, controlled, open-label trial to assess if AnapnoGuard System can minimize tracheal microaspiration and the risk of ventilator-associated pneumonia when compared to sta...
Detailed Description
Maintaining the endotracheal tube (ETT) cuff appropriately inflated plays a crucial role in the management of intubated patients because overinflation may cause tracheal wall damage, ulcerations and s...
Eligibility Criteria
Inclusion
- Primary intubation with the study ETT
- Expected duration of mechanical ventilation \>48 hours
- Age older than 18 years
Exclusion
- Invasive mechanical ventilation in the last 14 days,
- Contraindication for enteral feeding
- Clinical evidence of inhalation before intubation
- Pregnancy
- Enrolling in another study that may interfere with this trial
Key Trial Info
Start Date :
June 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2024
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT05403320
Start Date
June 6 2022
End Date
April 9 2024
Last Update
May 7 2024
Active Locations (11)
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1
Shamir Medical Center
Tel Aviv, Israel
2
Azienda ospedaliera universitaria "Ospedali riuniti di Ancona"
Ancona, Italy
3
Azienda ospedaliera universitaria "Policlinico di Bari"
Bari, Italy
4
Humanitas Research Hospital
Milan, Italy