The Gravity-VAP (Ventilator-Associated Pneumonia) Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective, Randomized, Multi-Center Trial of Lateral Trendelenburg Versus Semi-Recumbent Body Position in Mechanically Ventilated Patients For The Prevention of Ventilator-Associated Pneumonia

Conditions
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Ventilator Associated Pneumonia

Intervention / Treatment
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* Other: lateral-Trendelenburg position


Participation Criteria
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Eligibility Criteria
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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 Pregnancy Orthopedic problems that will not allow the patient to be kept in one of the study positions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Semirecumbent position<br>Semirecumbent position of patients on mechanical ventilation in the bed of the ICU | Other: lateral-Trendelenburg position<br>* lateral-Trendelenburg position of patients laying in the bed of the ICU, keeping trachea and tracheal tube horizontal, compared to the standard treatment (semirecumbent position) for the prevention of VAP<br>|
| Experimental: lateral-Trendelenburg position<br>lateral-Trendelenburg position of patients on mechanical ventilation in the bed of the ICU | Other: lateral-Trendelenburg position<br>* lateral-Trendelenburg position of patients laying in the bed of the ICU, keeping trachea and tracheal tube horizontal, compared to the standard treatment (semirecumbent position) for the prevention of VAP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of mechanical ventilation |  | 14 days | 
| Duration of intensive care unit stay |  | days | 
| Duration of hospital stay |  | days | 
| Safety of the Semi-Recumbent and Lateral-Trendelenburg position |  | 14 days | 
| Use of Sedatives |  | 14 days | 
| Use of Antimicrobials |  | 14 days | 
| ICU mortality |  | 28 days | 
| Hospital mortality |  | 28 days | 
| 28 Days mortality |  | 28 days | 
| Assessment of nursing-related issues in the lateral-Trendelenburg position |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VAP