NCT01138540

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).

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2010

Typical duration for phase_3

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

4.4 years

First QC Date

June 4, 2010

Last Update Submit

June 14, 2017

Conditions

Ventilator Associated Pneumonia

Keywords

VAP

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Duration of mechanical ventilation

    14 days

  • Duration of intensive care unit stay

    days

  • Duration of hospital stay

    days

  • Safety of the Semi-Recumbent and Lateral-Trendelenburg position

    14 days

  • Use of Sedatives

    14 days

  • +5 more secondary outcomes

Study Arms (2)

Semirecumbent position

ACTIVE COMPARATOR

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

Other: lateral-Trendelenburg position

lateral-Trendelenburg position

EXPERIMENTAL

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

Other: lateral-Trendelenburg position

Interventions

lateral-Trendelenburg positionOTHER

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

Semirecumbent positionlateral-Trendelenburg position

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Mi, 20122, Italy

Location

Hospital Clinic

Barcelona, 08036, Spain

Location

Related Publications (1)

  • 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.

    PMID: 29149418DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 4, 2010

First Posted

June 7, 2010

Study Start

November 1, 2010

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

June 16, 2017

Record last verified: 2017-06

Locations

IT(1)ES(1)