NCT04612608

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 6, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

May 26, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

7 months

First QC Date

October 6, 2020

Last Update Submit

April 8, 2022

Conditions

ARDS, Human

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Control

NO INTERVENTION

Usual Care

Intervention

ACTIVE COMPARATOR

Intervention arm

Procedure: upright bed

Interventions

upright bedPROCEDURE

moving the bed into an upright position

Intervention

Eligibility Criteria

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

You may qualify if:

  • Berlin criteria ARDS

You may not qualify if:

  • ARDS greater than 72 hours
  • Neurologic disease known to prolong weaning
  • Pregnancy
  • Known diagnosis of pulmonary fibrosis
  • Implanted cardiac pacer/defibrillator
  • prisoner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The intervention arm will undergo a protocol of 4x per day bed elevation to 60 degrees for 30 minutes.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 6, 2020

First Posted

November 3, 2020

Study Start

May 26, 2021

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

April 12, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

Investigators will plan to make individual participant data (IPD) available to other researchers

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
The data will be available one year following initial study publication for an additional one year
Access Criteria
Discussion of purpose of request with the primary investigator

Locations

US(1)