Early Identification and Prevention of Extubation Failure in Adults Using Integrated Pulmonary Index
IPI
1 other identifier
interventional
174
1 country
1
Brief Summary
The primary aim of this study is to compare reintubation rate when using standard medical therapy (SMT) versus a monitoring tool, Integrated Pulmonary Index (IPI), to alert clinicians of the patient's respiratory status and need for therapy after planned extubation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2020
1 active site
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
January 13, 2020
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedStudy Start
First participant enrolled
March 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedApril 8, 2021
April 1, 2021
1.1 years
January 13, 2020
April 6, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Reintubation rate at 72hours
Reintubation rate defined as requiring re-intubation and returning to mechanical ventilation within 72 hours after the initial discontinuation from the ventilation due to respiratory failure
72 hours
Secondary Outcomes (3)
Reintubation rate at 7 days
7 days
ICU length of stay
upto 12 weeks
ICU mortality
upto 12 weeks
Study Arms (2)
IPI group
EXPERIMENTALIPI monitoring
Control group
NO INTERVENTIONStandard monitoring
Interventions
Eligibility Criteria
You may qualify if:
- Adult subjects 18 years and older, endotracheally intubated and receiving assisted mechanical ventilation for more than 24hours, and
- Subjects under planned extubation based on the medical team approval
You may not qualify if:
- Subjects who are less than 18 years old,
- are pregnant,
- have tracheostomy tube as they do not qualify for extubation,
- have do-not-resuscitate or do-not-intubate orders,
- accidental or self-extubated patients,
- reintubation after study enrollment,
- are extubated terminally, or
- receiving extracorporeal membrane oxygenation (ECMO)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rush University Medical Center
Chicago, Illinois, 60612, United States
Related Publications (1)
Kaur R, Vines DL, Harnois LJ, Elshafei A, Johnson T, Balk RA. Identification and Prevention of Extubation Failure by Using an Automated Continuous Monitoring Alert Versus Standard Care. Respir Care. 2022 Oct;67(10):1282-1290. doi: 10.4187/respcare.09860. Epub 2022 Mar 28.
PMID: 35347080DERIVED
Study Officials
- STUDY CHAIR
David Vines, PhD
Rush University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Coordinator; MSc, RRT-ACCS, AE-C
Study Record Dates
First Submitted
January 13, 2020
First Posted
January 18, 2020
Study Start
March 9, 2020
Primary Completion
April 1, 2021
Study Completion
April 1, 2021
Last Updated
April 8, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share