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

NCT ID: NCT04612608

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-26
• Study Completion Date: 2022-01-01

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.

Conditions

ARDS, Human

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Intervention arm

Group Type: ACTIVE_COMPARATOR

upright bed

Intervention Type: PROCEDURE

moving the bed into an upright position

Interventions

upright bed

moving the bed into an upright position

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peter Morris

OTHER

Sponsor Role: lead

Responsible Party

Peter Morris

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

60328

Identifier Type: -

Identifier Source: org_study_id