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

This study has been terminated.
(Steering Committee accepted DSMB advise to terminate the study after review of data analysis at second interim analysis)
Sponsor:
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
Policlinico San Matteo Pavia Fondazione IRCCS
Azienda Ospedaliera - Universitaria di Modena
Ospedale Città di Sesto San Giovanni
Policlinico Universitario Agostino Gemelli
Azienda Ospedaliero-Universitaria di Parma
University Hospital, Frankfurt
Clinical Hospital Centre Zagreb
Santa Chiara Hospital
Hospital Clinic of Barcelona
Information provided by (Responsible Party):
Mauro Panigada, MD, Policlinico Hospital
ClinicalTrials.gov Identifier:
NCT01138540
First received: June 4, 2010
Last updated: June 14, 2017
Last verified: June 2017
  Purpose
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).

Condition Intervention Phase
Ventilator Associated Pneumonia Other: lateral-Trendelenburg position Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Mauro Panigada, MD, Policlinico Hospital:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • Duration of mechanical ventilation [ Time Frame: 14 days ]
  • Duration of intensive care unit stay [ Time Frame: days ]
  • Duration of hospital stay [ Time Frame: days ]
  • Safety of the Semi-Recumbent and Lateral-Trendelenburg position [ Time Frame: 14 days ]
  • Use of Sedatives [ Time Frame: 14 days ]
  • Use of Antimicrobials [ Time Frame: 14 days ]
  • ICU mortality [ Time Frame: 28 days ]
  • Hospital mortality [ Time Frame: 28 days ]
  • 28 Days mortality [ Time Frame: 28 days ]
  • Assessment of nursing-related issues in the lateral-Trendelenburg position [ Time Frame: 14 days ]

Estimated Enrollment: 800
Actual Study Start Date: November 2010
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138540

Locations
Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano, Mi, Italy, 20122
Spain
Hospital Clinic
Barcelona, Spain, 08036
Sponsors and Collaborators
Policlinico Hospital
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
Policlinico San Matteo Pavia Fondazione IRCCS
Azienda Ospedaliera - Universitaria di Modena
Ospedale Città di Sesto San Giovanni
Policlinico Universitario Agostino Gemelli
Azienda Ospedaliero-Universitaria di Parma
University Hospital, Frankfurt
Clinical Hospital Centre Zagreb
Santa Chiara Hospital
Hospital Clinic of Barcelona
  More Information

Responsible Party: Mauro Panigada, MD, MD, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT01138540     History of Changes
Other Study ID Numbers: Gravity-VAP Trial
Study First Received: June 4, 2010
Last Updated: June 14, 2017

Keywords provided by Mauro Panigada, MD, Policlinico Hospital:
VAP

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury

ClinicalTrials.gov processed this record on September 21, 2017