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

Not Applicable

Completed

• Conditions: ARDS, Human
• Interventions: Procedure: upright bed

• Registration Number: NCT04612608
• Lead Sponsor: Peter Morris

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.

Study Timeline

• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-30
• Study First Posted: 2020-11-03
• Study Start: 2021-05-26
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-08
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	upright bed	Intervention arm

Primary Outcome Measures

Name	Time	Method
highest value per day of mechanical ventilation of total respiratory system compliance	from the day of randomization, every day of mechanical ventilation until death or liberation from mechanical ventilation up to day 28	total respiratory system compliance measured 4x daily for each day of mechanical ventilation

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States