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

ARDS, Human Clinical Trial

— ARISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04612608
• Other study ID #: 60328
• Status: Completed
• Phase: N/A
• Start date: May 26, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: April 2022
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS, Human
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Procedure:
• upright bed
moving the bed into an upright position

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Peter Morris

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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