Assessing the Role of Inclined Positioning in Acute Respiratory Distress Syndrome Patients Recovery (ARISE)
Primary Purpose
ARDS, Human
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
upright bed
Sponsored by
About this trial
This is an interventional treatment trial for ARDS, Human
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
Sites / Locations
- University of Kentucky
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control
Intervention
Arm Description
Usual Care
Intervention arm
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04612608
Brief Title
Assessing the Role of Inclined Positioning in Acute Respiratory Distress Syndrome Patients Recovery
Acronym
ARISE
Official Title
Assessing the Role of Inclined Positioning in Acute Respiratory Distress Syndrome Patients Recovery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 26, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peter Morris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS, Human
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual Care
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Intervention arm
Intervention Type
Procedure
Intervention Name(s)
upright bed
Intervention Description
moving the bed into an upright position
Primary Outcome Measure Information:
Title
highest value per day of mechanical ventilation of total respiratory system compliance
Description
total respiratory system compliance measured 4x daily for each day of mechanical ventilation
Time Frame
from the day of randomization, every day of mechanical ventilation until death or liberation from mechanical ventilation up to day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Investigators will plan to make individual participant data (IPD) available to other researchers
IPD Sharing Time Frame
The data will be available one year following initial study publication for an additional one year
IPD Sharing Access Criteria
Discussion of purpose of request with the primary investigator
Learn more about this trial
Assessing the Role of Inclined Positioning in Acute Respiratory Distress Syndrome Patients Recovery
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