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

June 14, 2017 updated by: Mauro Panigada, MD, Policlinico Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of ventilator-associated pneumonia
Time Frame: 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)
14 days of mechanical ventilation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Hospital mortality
Time Frame: 28 days
28 days
Duration of hospital stay
Time Frame: days
days
Duration of mechanical ventilation
Time Frame: 14 days
14 days
Duration of intensive care unit stay
Time Frame: days
days
Safety of the Semi-Recumbent and Lateral-Trendelenburg position
Time Frame: 14 days
14 days
Use of Sedatives
Time Frame: 14 days
14 days
Use of Antimicrobials
Time Frame: 14 days
14 days
ICU mortality
Time Frame: 28 days
28 days
28 Days mortality
Time Frame: 28 days
28 days
Assessment of nursing-related issues in the lateral-Trendelenburg position
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Policlinico Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Gravity-VAP Trial

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