NCT06301867

Brief Summary

More than 300,00 people in the United States experience acute respiratory failure and require mechanical ventilation every year. Of those that recover and are extubated, the most common reason for reintubation is recurrent respiratory failure. Our study proposes a novel methodology for identifying those patients most at risk for recurrent respiratory failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
248

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

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

Study Start

First participant enrolled

March 1, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2024

Completed
Last Updated

November 21, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

March 4, 2024

Last Update Submit

November 19, 2024

Conditions

Mechanical Ventilation ComplicationWeaning Failure

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients who had a plateau pressure measured prior to extubation as a measure of feasibility

    Feasibility is defined as 95% of patients having had a plateau pressure measured prior to extubation.

    Day 0

Secondary Outcomes (1)

  • Percentage of patients who were reintubated prior to hospital discharge

    Day 0 to Day 90

Study Arms (1)

Extubated Patients

All patients receiving mechanical ventilation who are extubated in the intensive care units during the study period.

Diagnostic Test: Plateau Pressure

Interventions

Plateau PressureDIAGNOSTIC_TEST

Plateau pressure will be measured on all patients in the participating intensive care units prior to extubation.

Extubated Patients

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All mechanically ventilated patients in participating intensive care units.

You may qualify if:

  • Extubated in participating ICU during study period

You may not qualify if:

  • Previously extubated during hospitaliztion
  • Extubation as part of transitioning to comfort measures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 8, 2024

Study Start

March 1, 2024

Primary Completion

July 21, 2024

Study Completion

November 5, 2024

Last Updated

November 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)