Ventilator Associated PneumoniaPhase 3Gravity-VAPNCT01138540
The Gravity-VAP (Ventilator-Associated Pneumonia) Trial
A Phase 3 study testing lateral-Trendelenburg position in people with Ventilator Associated Pneumonia, run by Policlinico Hospital at 2 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- lateral-Trendelenburg position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2010to Apr 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Italy1 site
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Mi, 20122
About this study
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
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).
Read the 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.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- lateral-Trendelenburg position
- Keywords
- VAP
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Semirecumbent position | Active comparator | Semirecumbent position of patients on mechanical ventilation in the bed of the ICU Receives: Other: lateral-Trendelenburg position |
| lateral-Trendelenburg position | Experimental | lateral-Trendelenburg position of patients on mechanical ventilation in the bed of the ICU Receives: Other: lateral-Trendelenburg position |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 14 days of mechanical ventilation
Secondary outcomes (10)
Duration of mechanical ventilation
Measured: 14 days
Duration of intensive care unit stay
Measured: days
Duration of hospital stay
Measured: days
Safety of the Semi-Recumbent and Lateral-Trendelenburg position
Measured: 14 days
Use of Sedatives
Measured: 14 days
Use of Antimicrobials
Measured: 14 days
ICU mortality
Measured: 28 days
Hospital mortality
Measured: 28 days
28 Days mortality
Measured: 28 days
Assessment of nursing-related issues in the lateral-Trendelenburg position
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startNov 2010
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: Steering Committee accepted DSMB advise to terminate the study after review of data analysis at second interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Azienda Ospedaliera San Gerardo di Monza, Ospedale Nuovo del Mugello, Ospedale San Donato, Azienda USL Reggio Emilia - IRCCS, Ospedale S. Giovanni Bosco, Fondazione IRCCS Policlinico San Matteo di Pavia, Azienda Ospedaliero-Universitaria di Modena, Ospedale Città di Sesto San Giovanni, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Azienda Ospedaliero-Universitaria di Parma, Goethe University, Clinical Hospital Centre Zagreb, Santa Chiara Hospital, Hospital Clinic of Barcelona
- Responsible party
- Principal investigator, Mauro Panigada, MD, Policlinico Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138540
- Sponsor's protocol ID
- Gravity-VAP Trial
- Acronym
- Gravity-VAP
- Status last verified
- Jun 2017
- First submitted
- 4 Jun 2010
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29149418
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01138540
- Acronym / sponsor ID
- Gravity-VAP / Gravity-VAP Trial
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- VAP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Steering Committee accepted DSMB advise to terminate the study after review of data analysis at second interim analysis
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Azienda Ospedaliera San Gerardo di Monza, Ospedale Nuovo del Mugello, Ospedale San Donato, Azienda USL Reggio Emilia - IRCCS, Ospedale S. Giovanni Bosco, Fondazione IRCCS Policlinico San Matteo di Pavia, Azienda Ospedaliero-Universitaria di Modena, Ospedale Città di Sesto San Giovanni, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Azienda Ospedaliero-Universitaria di Parma, Goethe University, Clinical Hospital Centre Zagreb, Santa Chiara Hospital, Hospital Clinic of Barcelona
- Study start
- Nov 2010 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 7 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semirecumbent position | Active comparator | Other: lateral-Trendelenburg positionSemirecumbent position of patients on mechanical ventilation in the bed of the ICU |
| lateral-Trendelenburg position | Experimental | Other: lateral-Trendelenburg positionlateral-Trendelenburg position of patients on mechanical ventilation in the bed of the ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lateral-Trendelenburg positionlateral-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 | Other | Semirecumbent position, lateral-Trendelenburg position |
Primary outcome
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)
10 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Steering Committee accepted DSMB advise to terminate the study after review of data analysis at second interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Derived from this study: PubMed 29149418Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lateral-Trendelenburg position in people with Ventilator Associated Pneumonia, run by Policlinico Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Steering Committee accepted DSMB advise to terminate the study after review of data analysis at second interim analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ventilator-associated pneumonia (time frame: 14 days of mechanical ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01138540, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2017.