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

Primary Purpose

Ventilator Associated Pneumonia

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

lateral-Trendelenburg position

About this trial

This is an interventional prevention trial for Ventilator Associated Pneumonia focused on measuring VAP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Hospital Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Semirecumbent position

lateral-Trendelenburg position

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Duration of mechanical ventilation

Duration of intensive care unit stay

Duration of hospital stay

Safety of the Semi-Recumbent and Lateral-Trendelenburg position

Use of Sedatives

Use of Antimicrobials

ICU mortality

Hospital mortality

28 Days mortality

Assessment of nursing-related issues in the lateral-Trendelenburg position

Full Information

NCT ID

NCT01138540

First Posted

June 4, 2010

Last Updated

June 14, 2017

Sponsor

Policlinico Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01138540

Brief Title

The Gravity-VAP (Ventilator-Associated Pneumonia) Trial

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Terminated

Why Stopped

Steering Committee accepted DSMB advise to terminate the study after review of data analysis at second interim analysis

Study Start Date

November 2010 (Actual)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Policlinico Hospital

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ventilator Associated Pneumonia

Keywords

VAP

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Semirecumbent position

Arm Type

Active Comparator

Arm Description

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

Arm Title

lateral-Trendelenburg position

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

lateral-Trendelenburg position

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of ventilator-associated pneumonia

Description

Time Frame

14 days of mechanical ventilation

Secondary Outcome Measure Information:

Title

Duration of mechanical ventilation

Time Frame

14 days

Title

Duration of intensive care unit stay

Time Frame

days

Title

Duration of hospital stay

Time Frame

days

Title

Safety of the Semi-Recumbent and Lateral-Trendelenburg position

Time Frame

14 days

Title

Use of Sedatives

Time Frame

14 days

Title

Use of Antimicrobials

Time Frame

14 days

Title

ICU mortality

Time Frame

28 days

Title

Hospital mortality

Time Frame

28 days

Title

28 Days mortality

Time Frame

28 days

Title

Assessment of nursing-related issues in the lateral-Trendelenburg position

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

City

Milano

State/Province

ZIP/Postal Code

20122

Country

Italy

Facility Name

Hospital Clinic

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

29149418

Citation

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.

Results Reference

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The Gravity-VAP (Ventilator-Associated Pneumonia) Trial

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