Assessing the Role of Inclined Positioning in Acute Respiratory Distress Syndrome Patients Recovery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of intermittent, nearly vertical, patient positioning in a specialized upright bed, on outcomes of mechanically ventilated patients with acute respiratory distress syndrome (ARDS) who are in the ICU.

Detailed Description
-----------------
The purpose of this study is to determine the effect of intermittent, nearly vertical, patient positioning in a specialized upright bed, on outcomes of mechanically ventilated patients with acute respiratory distress syndrome (ARDS) who are in the ICU. This study is a prospective, non-blinded, feasibility, randomized study of ARDS patients, who will be randomized into two treatment groups. One treatment arm will deliver scheduled sessions of upright bed positioning (study intervention), while the other treatment arm receives routine bed position care (care provided exclusively with the bed in the supine position). ICU Practitioners know that positional changes improve clinical outcomes when turning patients from supine to prone (back to belly); however, other positional changes including upright positioning are far less studied. It is well known that in ARDS patients who become proned, an improvement in aeration occurs in the dorsal lung regions (prone positioning has been shown to reduce ARDS mortality). Thus the investigators predict that in this study, the upright positioning holds the potential to further recruit collapsed lung areas. Augmentation of aerated lung while in the upright position is expected to increase the highest value measured per ventilator day of the respiratory system compliance in the upright bed position arm, in a greater fashion than the highest value measured per ventilator day of daily total respiratory system compliance for the usual care arm.

Official Title
-----------------
Assessing the Role of Inclined Positioning in Acute Respiratory Distress Syndrome Patients Recovery

Conditions
-----------------
ARDS, Human

Intervention / Treatment
-----------------
* Procedure: upright bed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Berlin criteria ARDS Exclusion Criteria: ARDS greater than 72 hours Neurologic disease known to prolong weaning Pregnancy Known diagnosis of pulmonary fibrosis Implanted cardiac pacer/defibrillator prisoner

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The intervention arm will undergo a protocol of 4x per day bed elevation to 60 degrees for 30 minutes.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual Care | |
| Active Comparator: Intervention<br>Intervention arm | Procedure: upright bed<br>* moving the bed into an upright position<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| highest value per day of mechanical ventilation of total respiratory system compliance | total respiratory system compliance measured 4x daily for each day of mechanical ventilation | from the day of randomization, every day of mechanical ventilation until death or liberation from mechanical ventilation up to day 28 |