Study Stopped
IRB approval expired
Change In Diaphragmatic Thickness Predicts Extubation Success
Can the Diaphragm Predict the Course of Mechanical Ventilation? A Prospective Study Evaluating Several M-Mode Ultrasound Measured Diaphragmatic Parameters and Their Effects on Weaning From Mechanical Ventilation
1 other identifier
observational
57
1 country
1
Brief Summary
We will investigate whether measurement of the change in thickness of the diaphragm during the respiratory cycle by ultrasound can predict extubation success in a 48 hour window. We will also asses whether this is only possible on low levels of pressure support as has been shown previously, or if this technique retains its predictive power at higher levels of pressure support.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 13, 2016
CompletedFirst Posted
Study publicly available on registry
January 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2017
CompletedResults Posted
Study results publicly available
March 9, 2020
CompletedMarch 9, 2020
January 1, 2016
2 years
January 13, 2016
February 24, 2020
February 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Extubation Success
Discontinuation from mechanical ventilation in 48 hours from ultrasound PI has left the institution. Efforts made to contact the PI were unsuccessful. No study data available.
48 hours
Secondary Outcomes (1)
Re-intubation
48 hours from removal of ventilatory support
Study Arms (1)
Main Cohort
all patients enrolled will have an ultrasound of their diaphragm performed once they are on a pressure support trial. Intervention: Diaphragm Ultrasound
Interventions
Once on a pressure support weaning trial, enrolled subjects will have an ultrasound of their right hemidiaphragm performed on three levels of pressure support: 15/5 10/5 and 5/5
Eligibility Criteria
Patients on mechanical ventilation in the intensive care unit
You may qualify if:
- age greater than 18, ventilated for \>24 hours
You may not qualify if:
- already chronically on mechanical ventilatory support, already has tracheostomy, has pathology that obscures visualization of the right hemidiaphragm, has acute stroke either hemorrhagic or ischemic, cannot identify appropriate decision maker to get informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
Limitations and Caveats
0 Participants analyzed. PI has left the institution. Efforts made to contact the PI were unsuccessful. No study data available.
Results Point of Contact
- Title
- Roberta Costello; Research Compliance
- Organization
- Albert Einstein Healthcare Network
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Blumhof, DO
Einstein Healthcare Network
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2016
First Posted
January 14, 2016
Study Start
January 1, 2015
Primary Completion
January 13, 2017
Study Completion
January 13, 2017
Last Updated
March 9, 2020
Results First Posted
March 9, 2020
Record last verified: 2016-01
Data Sharing
- IPD Sharing
- Will not share