The Gravity-VAP (Ventilator-Associated Pneumonia) Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Policlinico Hospital
Sponsor:
Collaborators:
Hospital Clinic of Barcelona
Massachusetts General Hospital
Azienda Ospedaliera San Gerardo di Monza
Information provided by (Responsible Party):
Mauro Panigada, MD, Policlinico Hospital
ClinicalTrials.gov Identifier:
NCT01138540
First received: June 4, 2010
Last updated: May 21, 2014
Last verified: May 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Policlinico Hospital:

Primary Outcome Measures:
  • Incidence of ventilator-associated pneumonia [ Time Frame: 14 days of mechanical ventilation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Duration of intensive care unit stay [ Time Frame: days ] [ Designated as safety issue: No ]
  • Duration of hospital stay [ Time Frame: days ] [ Designated as safety issue: No ]
  • Safety of the Semi-Recumbent and Lateral-Trendelenburg position [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Use of Sedatives [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Use of Antimicrobials [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • ICU mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Hospital mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • 28 Days mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Assessment of nursing-related issues in the lateral-Trendelenburg position [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: November 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (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
Genders Eligible for Study:   Both
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

Contacts
Contact: Mauro Panigada, MD +393356595545 mauro.panigada@policlinico.mi.it
Contact: Gianluigi Li Bassi, MD +34932275549 glibassi@clinic.ub.es

Locations
Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Recruiting
Milano, Mi, Italy, 20122
Contact: Mauro Panigada, MD    +390255033232    mauro.panigada@policlinico.mi.it   
Contact: Gianluigi Li Bassi    +34932275549    glibassi@clinic.ub.es   
Principal Investigator: Mauro Panigada, MD         
Spain
Hospital Clinic Recruiting
Barcelona, Spain, 08036
Contact: Gianluigi Li Bassi, MD    0034 932275549    glibassi@clinic.ub.es   
Principal Investigator: Gianluigi Li Bassi, MD         
Sponsors and Collaborators
Policlinico Hospital
Hospital Clinic of Barcelona
Massachusetts General Hospital
Azienda Ospedaliera San Gerardo di Monza
  More Information

No publications provided

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: May 21, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Policlinico Hospital:
VAP

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

ClinicalTrials.gov processed this record on October 23, 2014