The Gravity-VAP (Ventilator-Associated Pneumonia) Trial

Ventilator Associated Pneumonia Clinical Trial

— Gravity-VAP  

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01138540
• Other study ID #: Gravity-VAP Trial
• Status: Terminated
• Phase: Phase 3
• First received: June 4, 2010
• Last updated: June 14, 2017
• Start date: November 2010
• Est. completion date: April 2015

Study information

• Verified date: June 2017
• Source: Policlinico Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Other:
• lateral-Trendelenburg position
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

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano	Mi
Spain	Hospital Clinic	Barcelona

Sponsors (16)

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

Countries where clinical trial is conducted

Italy,  Spain, 

Outcome

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