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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
800
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
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Mi, Italy
Hospital Clinic
Barcelona, Spain
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)
Time frame: 14 days of mechanical ventilation
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
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