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

Sponsor

Peter Morris (Other)

Overall Status

Completed

CT.gov ID

NCT04612608

Collaborator

(none)

Enrollment

Location

Arms

7.2

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
ARDS, Human	Procedure: upright bed	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The intervention arm will undergo a protocol of 4x per day bed elevation to 60 degrees for 30 minutes.The intervention arm will undergo a protocol of 4x per day bed elevation to 60 degrees for 30 minutes.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 26, 2021

Actual Primary Completion Date :

Jan 1, 2022

Actual Study Completion Date :

Jan 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Usual Care
Active Comparator: Intervention Intervention arm	Procedure: upright bed moving the bed into an upright position

Arm

Intervention/Treatment

No Intervention: Control

Usual Care

Active Comparator: Intervention

Intervention arm

Procedure: upright bed

moving the bed into an upright position

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky	Lexington	Kentucky	United States	40536

Sponsors and Collaborators

Peter Morris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peter Morris, Professor, University of Kentucky

ClinicalTrials.gov Identifier:

NCT04612608

Other Study ID Numbers:

60328

First Posted:

Nov 3, 2020

Last Update Posted:

Apr 12, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Acute Lung Injury

Study Results

No Results Posted as of Apr 12, 2022