Clinical trial NCT01138540: The Gravity-VAP (Ventilator-Associated Pneumonia) Trial
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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Ventilator Associated Pneumonia
Keywords: VAP
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Azienda Ospedaliera San Gerardo di Monza
name: Ospedale Nuovo del Mugello
name: Ospedale San Donato
name: Azienda USL Reggio Emilia - IRCCS
name: Ospedale S. Giovanni Bosco
name: Fondazione IRCCS Policlinico San Matteo di Pavia
name: Azienda Ospedaliero-Universitaria di Modena
name: Ospedale Città di Sesto San Giovanni
name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Azienda Ospedaliero-Universitaria di Parma
name: Goethe University
name: Clinical Hospital Centre Zagreb
name: Santa Chiara Hospital
name: Hospital Clinic of Barcelona
First posted: 2010-06-07
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Incidence of ventilator-associated pneumonia
timeFrame: 14 days of mechanical ventilation
Secondary outcomes:
measure: Duration of mechanical ventilation
timeFrame: 14 days
measure: Duration of intensive care unit stay
timeFrame: days
measure: Duration of hospital stay
timeFrame: days
measure: Safety of the Semi-Recumbent and Lateral-Trendelenburg position
timeFrame: 14 days
measure: Use of Sedatives
timeFrame: 14 days
measure: Use of Antimicrobials
timeFrame: 14 days
measure: ICU mortality
timeFrame: 28 days
measure: Hospital mortality
timeFrame: 28 days
measure: 28 Days mortality
timeFrame: 28 days
measure: Assessment of nursing-related issues in the lateral-Trendelenburg position
timeFrame: 14 days
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
state: Mi
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
References:
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.