The Gravity-VAP (Ventilator-Associated Pneumonia) Trial

Phase 3

Terminated

• Conditions: Ventilator Associated Pneumonia
• Interventions: Other: lateral-Trendelenburg position

• Registration Number: NCT01138540
• Lead Sponsor: Policlinico Hospital

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.

Study Timeline

• Study First Submitted: 2010-06-04
• Study First Submitted QC: 2010-06-04
• Study First Posted: 2010-06-07
• Study Start: 2010-11
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-14
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Semirecumbent position	lateral-Trendelenburg position	Semirecumbent position of patients on mechanical ventilation in the bed of the ICU
lateral-Trendelenburg position	lateral-Trendelenburg position	lateral-Trendelenburg position of patients on mechanical ventilation in the bed of the ICU

Primary Outcome Measures

Name	Time	Method
Incidence of ventilator-associated pneumonia	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 Outcome Measures

Name	Time	Method
28 Days mortality	28 days
Use of Antimicrobials	14 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
ICU mortality	28 days
Hospital mortality	28 days
Assessment of nursing-related issues in the lateral-Trendelenburg position	14 days

Trial Locations

Locations (2)

Hospital Clinic; 🇪🇸 Barcelona, Spain

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; 🇮🇹 Milano, Mi, Italy