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OpenTrials
Completed

NCT Number: NCT04612608

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

upright bed

Procedure

moving the bed into an upright position

Primary outcomes

  1. highest value per day of mechanical ventilation of total respiratory system compliance

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Peter Morris

Other

Registry information

Acronym: ARISE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 3, 2020
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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