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Change In Diaphragmatic Thickness Predicts Extubation Success

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02656199
Recruitment Status : Terminated (IRB approval expired)
First Posted : January 14, 2016
Results First Posted : March 9, 2020
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
Albert Einstein Healthcare Network

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.

Condition or disease Intervention/treatment
Mechanical Ventilation Complication Procedure: Diaphragm Ultrasound

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Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : January 2015
Actual Primary Completion Date : January 13, 2017
Actual Study Completion Date : January 13, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
Main Cohort
all patients enrolled will have an ultrasound of their diaphragm performed once they are on a pressure support trial. Intervention: Diaphragm Ultrasound
Procedure: Diaphragm Ultrasound
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




Primary Outcome Measures :
  1. Extubation Success [ Time Frame: 48 hours ]

    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.



Secondary Outcome Measures :
  1. Re-intubation [ Time Frame: 48 hours from removal of ventilatory support ]
    Reinstitution of mechanical ventilation within 48 hours of extubation PI has left the institution. Efforts made to contact the PI were unsuccessful. No study data available.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients on mechanical ventilation in the intensive care unit
Criteria

Inclusion Criteria:

  • age greater than 18, ventilated for >24 hours

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656199


Locations
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United States, Pennsylvania
Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Sponsors and Collaborators
Albert Einstein Healthcare Network
Investigators
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Principal Investigator: Scott Blumhof, DO Einstein Healthcare Network

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Responsible Party: Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT02656199    
Other Study ID Numbers: 4541
First Posted: January 14, 2016    Key Record Dates
Results First Posted: March 9, 2020
Last Update Posted: March 9, 2020
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Albert Einstein Healthcare Network:
Diaphragm
Ventilators, Mechanical