The Gravity-VAP (Ventilator-Associated Pneumonia) Trial

Policlinico Hospital

Status and phase: Terminated; Phase 3

Conditions: Ventilator Associated Pneumonia

Treatments: Other: lateral-Trendelenburg position

Study type: Interventional

Funder types: Other

Identifiers

NCT01138540

Gravity-VAP Trial

Details and patient eligibility

About

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).

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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800 participants in 2 patient groups

Semirecumbent position

Active Comparator group

Description:

Semirecumbent position of patients on mechanical ventilation in the bed of the ICU

Treatment:

Other: lateral-Trendelenburg position

lateral-Trendelenburg position

Experimental group

Description:

lateral-Trendelenburg position of patients on mechanical ventilation in the bed of the ICU

Treatment:

Other: lateral-Trendelenburg position