Prospective, Randomized, Multi-Center Trial of Lateral Trendelenburg Versus Semi-Recumbent Body Position in Mechanically Ventilated Patients For The Prevention of Ventilator-Associated Pneumonia
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Ventilator Associated Pneumonia
- Sponsor
- Policlinico Hospital
- Enrollment
- 800
- Locations
- 2
- Primary Endpoint
- Incidence of ventilator-associated pneumonia
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
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 to prevent incidence of ventilator-associated pneumonia (VAP).
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-associated pneumonia. The semi-recumbent position prevents gastro-oropharyngeal aspiration of bacteria laden gastric contents and the "gastro-pulmonary" route of colonization. The lateral-Trendelenburg position aims to promote outward drainage of bacteria-laden oropharyngeal secretion, while avoiding bacterial translocation from the oropharynx into the lungs.
Investigators
Mauro Panigada, MD
MD
Policlinico Hospital
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Incidence of ventilator-associated pneumonia
Time Frame: 14 days of mechanical ventilation
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)
Secondary Outcomes
- 28 Days mortality(28 days)
- Duration of hospital stay(days)
- Safety of the Semi-Recumbent and Lateral-Trendelenburg position(14 days)
- Duration of mechanical ventilation(14 days)
- Duration of intensive care unit stay(days)
- Use of Sedatives(14 days)
- Use of Antimicrobials(14 days)
- ICU mortality(28 days)
- Hospital mortality(28 days)
- Assessment of nursing-related issues in the lateral-Trendelenburg position(14 days)