NCT07025421

Brief Summary

The pilot study will randomize 40 ARDS patients who if proning were required would be randomized to upright bed positioning or to stand of care with bed in the head of bed elevation position

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Aug 2025Aug 2026

First Submitted

Initial submission to the registry

June 9, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 25, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

10 months

First QC Date

June 9, 2025

Last Update Submit

August 25, 2025

Conditions

Acute Respiratory Distress Syndrome

Keywords

Bed Position

Outcome Measures

Primary Outcomes (1)

  • Change in Tidal Volume

    Mechanical Ventilator Tidal Volume

    within first 7 days of mechanical ventilation

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Upright bed positioning

Other: Intervention Upright Bed positioning

Standard of Care

NO INTERVENTION

Standard of Care Head of Bed Elevation

Interventions

Intervention Upright Bed positioningOTHER

Patient in receipt of the upright bed positioning will receive daily upright bed positioning time each day of mechanical ventilation following the time required by institutional protocol for ARDS - associated prone positioning

Intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Acute Respiratory Distress Syndrome

You may not qualify if:

  • Cancer
  • Active tracheostomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35223, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Central Study Contacts

peter morris, md

CONTACT

205-934-5548pmorris@uabmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 9, 2025

First Posted

June 17, 2025

Study Start

August 25, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Review with the UAB IRB for each request

Shared Documents
CSR
Time Frame
2028 - 2030
Access Criteria
All credible research organizations - please contact the UAB Pulmonary Division office

Locations

US(1)