The Gravity-VAP (Ventilator-Associated Pneumonia) Trial (Gravity-VAP)

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

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).

Study Overview

• Status: Terminated
• Conditions: Ventilator Associated Pneumonia
• Intervention / Treatment: Other: lateral-Trendelenburg position

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 Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Mi
    • Milano, Mi, Italy, 20122
      • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Semirecumbent position; Semirecumbent position of patients on mechanical ventilation in the bed of the ICU	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
Experimental: lateral-Trendelenburg position; lateral-Trendelenburg position of patients on mechanical ventilation in the bed of the ICU	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

What is the study measuring?

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	Time Frame
Hospital mortality	28 days
Duration of hospital stay	days
Duration of mechanical ventilation	14 days
Duration of intensive care unit 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
28 Days mortality	28 days
Assessment of nursing-related issues in the lateral-Trendelenburg position	14 days

Collaborators and Investigators

• Sponsor: Policlinico Hospital
• Collaborators: Massachusetts General Hospital; Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Hospital Clinic of Barcelona; Ospedale San Donato; Clinical Hospital Centre Zagreb; Azienda Ospedaliero-Universitaria di Parma; Azienda Ospedaliero-Universitaria di Modena; Arcispedale Santa Maria Nuova-IRCCS; Santa Chiara Hospital; Azienda Ospedaliera San Gerardo di Monza; University Hospital Frankfurt; Ospedale S. Giovanni Bosco; Fondazione IRCCS Policlinico San Matteo di Pavia; Ospedale Nuovo del Mugello; Ospedale Città di Sesto San Giovanni

Publications and helpful links

General Publications

• Li Bassi G, Panigada M, Ranzani OT, Zanella A, Berra L, Cressoni M, Parrini V, Kandil H, Salati G, Selvaggi P, Amatu A, Sanz-Moncosi M, Biagioni E, Tagliaferri F, Furia M, Mercurio G, Costa A, Manca T, Lindau S, Babel J, Cavana M, Chiurazzi C, Marti JD, Consonni D, Gattinoni L, Pesenti A, Wiener-Kronish J, Bruschi C, Ballotta A, Salsi P, Livigni S, Iotti G, Fernandez J, Girardis M, Barbagallo M, Moise G, Antonelli M, Caspani ML, Vezzani A, Meybohm P, Gasparovic V, Geat E, Amato M, Niederman M, Kolobow T, Torres A; Gravity-VAP Network. Randomized, multicenter trial of lateral Trendelenburg versus semirecumbent body position for the prevention of ventilator-associated pneumonia. Intensive Care Med. 2017 Nov;43(11):1572-1584. doi: 10.1007/s00134-017-4858-1. Epub 2017 Jun 20.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2010
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: June 4, 2010
• First Submitted That Met QC Criteria: June 4, 2010
• First Posted (Estimate): June 7, 2010

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: June 14, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: VAP
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: Gravity-VAP Trial