Not provided
Not provided
Not provided
Not provided
Steering Committee accepted DSMB advise to terminate the study after review of data analysis at second interim analysis
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| Azienda Ospedaliera San Gerardo di Monza | OTHER |
| Ospedale Nuovo del Mugello | UNKNOWN |
| Ospedale San Donato |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semirecumbent position | Active Comparator | Semirecumbent position of patients on mechanical ventilation in the bed of the ICU |
|
| lateral-Trendelenburg position | Experimental | lateral-Trendelenburg position of patients on mechanical ventilation in the bed of the ICU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lateral-Trendelenburg position | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of mechanical ventilation | 14 days | |
| Duration of intensive care unit stay | days | |
| Duration of hospital stay |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | Mi | 20122 | Italy | ||
| Hospital Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29149418 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
Not provided
Not provided
| OTHER |
| Azienda USL Reggio Emilia - IRCCS | OTHER_GOV |
| Ospedale S. Giovanni Bosco | OTHER |
| Fondazione IRCCS Policlinico San Matteo di Pavia | OTHER |
| Azienda Ospedaliero-Universitaria di Modena | OTHER |
| Ospedale Città di Sesto San Giovanni | UNKNOWN |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | OTHER |
| Azienda Ospedaliero-Universitaria di Parma | OTHER |
| Goethe University | OTHER |
| Clinical Hospital Centre Zagreb | OTHER |
| Santa Chiara Hospital | OTHER |
| Hospital Clinic of Barcelona | OTHER |
Not provided
Not provided
Not provided
Not provided
| days |
| Safety of the Semi-Recumbent and Lateral-Trendelenburg position | 14 days |
| Use of Sedatives | 14 days |
| Use of Antimicrobials | 14 days |
| ICU mortality | 28 days |
| Hospital mortality | 28 days |
| 28 Days mortality | 28 days |
| Assessment of nursing-related issues in the lateral-Trendelenburg position | 14 days |
| Barcelona |
| 08036 |
| Spain |
| D012141 |
| Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |