Ventilator Associated Pneumonia Clinical Trial
— Gravity-VAPOfficial title:
Prospective, Randomized, Multi-Center Trial of Lateral Trendelenburg Versus Semi-Recumbent Body Position in Mechanically Ventilated Patients For The Prevention of Ventilator-Associated Pneumonia
Verified date | June 2017 |
Source | Policlinico Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 to prevent incidence of ventilator-associated pneumonia (VAP).
Status | Terminated |
Enrollment | 800 |
Est. completion date | April 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age = 18 years 2. Patients expected to be oro-tracheally intubated for at least 48 hours or longer 3. Enrollment time window within 12 hours following intubation Exclusion Criteria: 1. Current and past participation in an other intervention trial conflicting with the present study 2. Previous endotracheal intubation longer than 12 hours during the previous 30 days 3. Patients with documented bronchiectasis 4. Cystic fibrosis 5. Witnessed pulmonary aspiration either prior or at intubation 6. Patients with increased intracranial pressure, brain edema; or medical conditions that can worsen with increase in intracranial pressure 7. Patients with significant heart failure and activity impairment (Class III-IV of the New York Heart Association (NYHA) 8. Spinal cord injury 9. BMI > 35, or weight above 300 pound 10. 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 11. Pregnancy 12. Orthopedic problems that will not allow the patient to be kept in one of the study positions |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milano | Mi |
Spain | Hospital Clinic | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Policlinico Hospital | Arcispedale Santa Maria Nuova-IRCCS, Azienda Ospedaliera - Universitaria di Modena, Azienda Ospedaliera San Gerardo di Monza, Azienda Ospedaliero-Universitaria di Parma, Clinical Hospital Centre Zagreb, Hospital Clinic of Barcelona, Massachusetts General Hospital, Ospedale Città di Sesto San Giovanni, Ospedale Nuovo del Mugello, Ospedale S. Giovanni Bosco, Ospedale San Donato, Policlinico San Matteo Pavia Fondazione IRCCS, Policlinico Universitario Agostino Gemelli, Santa Chiara Hospital, University Hospital, Frankfurt |
Italy, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of ventilator-associated pneumonia | incidence of ventilator-associated pneumonia within the first 14 days of intubation, confirmed by quantitative microbiology analysis of either bronchoalveolar lavage (BAL) or mini-BAL fluids or secretions collected through protected specimen brush (PSB) | 14 days of mechanical ventilation | |
Secondary | Duration of mechanical ventilation | 14 days | ||
Secondary | Duration of intensive care unit stay | days | ||
Secondary | Duration of hospital stay | days | ||
Secondary | Safety of the Semi-Recumbent and Lateral-Trendelenburg position | 14 days | ||
Secondary | Use of Sedatives | 14 days | ||
Secondary | Use of Antimicrobials | 14 days | ||
Secondary | ICU mortality | 28 days | ||
Secondary | Hospital mortality | 28 days | ||
Secondary | 28 Days mortality | 28 days | ||
Secondary | Assessment of nursing-related issues in the lateral-Trendelenburg position | 14 days |
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