Status:
TERMINATED
The Gravity-VAP (Ventilator-Associated Pneumonia) Trial
Lead Sponsor:
Policlinico Hospital
Collaborating Sponsors:
Massachusetts General Hospital
Azienda Ospedaliera San Gerardo di Monza
Conditions:
Ventilator Associated Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is planned to compare, in patients sedated, intubated and mechanically ventilated, the efficacy and safety of the Lateral Trendelenburg position in comparison to the Semirecumbent Position ...
Detailed Description
This study is planned to compare, in patients sedated, intubated or tracheostomized and mechanically ventilated, the efficacy and safety of two body positions in reducing incidence of ventilator-assoc...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Patients expected to be oro-tracheally intubated for at least 48 hours or longer
- Enrollment time window within 12 hours following intubation
Exclusion
- Current and past participation in an other intervention trial conflicting with the present study
- Previous endotracheal intubation longer than 12 hours during the previous 30 days
- Patients with documented bronchiectasis
- Cystic fibrosis
- Witnessed pulmonary aspiration either prior or at intubation
- Patients with increased intracranial pressure, brain edema; or medical conditions that can worsen with increase in intracranial pressure
- Patients with significant heart failure and activity impairment (Class III-IV of the New York Heart Association (NYHA)
- Spinal cord injury
- BMI \> 35, or weight above 300 pound
- Grade IV Intra-abdominal pressure: IAP \> 25 mmHg or abdominal compartment syndrome , defined as a sustained IAP \> 20 mmHg that is associated with new organ dysfunction / failure
- Pregnancy
- Orthopedic problems that will not allow the patient to be kept in one of the study positions
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2015
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT01138540
Start Date
November 1 2010
End Date
April 1 2015
Last Update
June 16 2017
Active Locations (2)
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1
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Mi, Italy, 20122
2
Hospital Clinic
Barcelona, Spain, 08036