Clinical Trials Directory

Trials / Terminated

TerminatedNCT04176445

Body Positioning and Pulmonary Aeration During Mechanical Ventilation

Influence of Body Positioning on Pulmonary Aeration Among Mechanically Ventilated Critical Ill Patients

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
19 (actual)
Sponsor
Hospital Moinhos de Vento · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The present randomized crossover clinical trial aims to evaluate the influence of different body postures on pulmonary aeration among mechanically ventilated critically ill patients. Patients admitted to the intensive care unit receiving invasive mechanical ventilation \>24 hours, and without contraindications to mobilization, will be randomly assigned to one of two sequences of interventions at a single day: arm 1: bedside sitting posture followed by orthostatic board at 45º and 60º; arm 2: orthostatic board at 45º, 60º and 80º followed by bedside sitting posture. Each postural protocol (bedside sitting posture protocol or orthostatic board posture protocol) will last 30 minutes. A washout window period between 1,5h and 2,5h will be applied between the two postural interventions. The primary outcome is the lung aeration assessed using the Lung Ultrasound Score (LUS) performed by trained evaluators at the end of postural protocol. Secondary outcomes include ventilatory mechanics (static compliance, airway resistance and respiratory work), PaO2/FiO2 ratio, Level of consciousness according to the Richmond Agitation-Sedation Scale (RASS), and adverse events (hypertension, hypotension, tachicardia, bradycardia, tachypnea, bradypnea, decreased level of consciousness, patient distress, fall to knees, invasive device traction or loss, filter hemodialysis clotting or disruption).

Conditions

Interventions

TypeNameDescription
DEVICEOrthostatic board posturePatients will be verticalized at at 45º, 60º and 80º using an orthostatic board. The total posture protocol will last 30 minutes
OTHERBedside sitting posturePatients will be placed at the bedside, with support for the back and upper limbs. They will be kept at 90º of hip and knee flexion and feet supported. The total posture protocol will last 30 minutes.

Timeline

Start date
2019-12-03
Primary completion
2020-07-31
Completion
2020-07-31
First posted
2019-11-25
Last updated
2021-12-13
Results posted
2021-12-13

Locations

2 sites across 1 country: Brazil

Source: ClinicalTrials.gov record NCT04176445. Inclusion in this directory is not an endorsement.