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

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.

Study Overview

• Status: Completed
• Conditions: ARDS, Human
• Intervention / Treatment: Procedure: upright bed

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University Of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Peter Morris

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2021
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 30, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 8, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 60328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No