Ventilator Associated Pneumonia
Conditions
Keywords
VAP
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.
Interventions
OTHERlateral-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
Sponsors
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
Policlinico Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ventilator-associated pneumonia | 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) |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Duration of mechanical ventilation | 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 |
| Use of Antimicrobials | 14 days |
Countries
Italy, Spain
Outcome results
None listed