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Diaphragm Ultrasound Measurements With Variations in Modes of Ventilation

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ClinicalTrials.gov Identifier: NCT04319939
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
The overall objective of the study is to conduct an observational study involving intensive care unit patients receiving mechanical ventilation and determine if there are differences in diaphragm thickness ultrasound measurements during expiratory and inspiratory phases in a controlled and spontaneous mode.

Condition or disease Intervention/treatment
Mechanical Ventilation Other: Assist Control Mode and Pressure Support Mode Mechanical Ventilation

Detailed Description:

In this study diaphragm ultrasound measurements at end-expiration and peak inspiration phases in assist control and pressure support mode in consented patients admitted to the medical intensive care unit. One-time measurements will be obtained during the first 48hrs that the patients are receiving mechanical ventilation.

Three consecutive images will be obtained by an investigator that is blinded to the mode (controlled vs. spontaneous). Once measurements are obtained, a second investigator will switch to the other mode (controlled vs. spontaneous) and the blinded investigator will obtain three consecutive images after the patient has adjusted to the subsequent mode (one minute). Tidal volumes will be matched between modes as close as possible. The order of modes to ultrasound (controlled then spontaneous or spontaneous then controlled) will be determined by the non-blinded second investigator. Once the ultrasound measurements are obtained by the research team, image acquisition is concluded for the enrolled patient. The ventilator will be programmed back to the original settings determined by the medical ICU team.

The hypothesis is that the end-expiration diaphragm ultrasound measurement will be thicker in spontaneous mode than controlled mode.

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Study Type : Observational
Estimated Enrollment : 66 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diaphragm Ultrasound Measurements With Variations in Modes of Ventilation
Actual Study Start Date : February 5, 2020
Estimated Primary Completion Date : January 6, 2021
Estimated Study Completion Date : January 6, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
Participants receiving mechanical ventilation Other: Assist Control Mode and Pressure Support Mode Mechanical Ventilation
Diaphragm ultrasound measurements (end expiration and peak inspiration thickness) will be performed in assist control mode and pressure support mode mechanical ventilation in each participant. The participant will thus serve as his/her own control for these interventions.




Primary Outcome Measures :
  1. End expiratory diaphragm thickness in controlled and spontaneous modes [ Time Frame: Less than 48 hours after mechanical ventilation ]
    Diaphragm ultrasound measurement at end expiration in assist control mode and pressure support mode


Secondary Outcome Measures :
  1. Thickening fraction in controlled and spontaneous modes [ Time Frame: Less than 48 hours after mechanical ventilation ]
    Diaphragm ultrasound measurement at end expiration and inspiration to calculate thickening fraction = (peak inspiration thickness - end expiration thickness)/end expiration thickness in assist control and pressure support mode ventilation

  2. Variance in peak inspiration thickness in controlled and spontaneous modes [ Time Frame: Less than 48 hours after mechanical ventilation ]
    Diaphragm ultrasound measurement at peak inspiration in assist control and pressure support

  3. p0.1 measurements in controlled and spontaneous modes [ Time Frame: Less than 48 hours after mechanical ventilation ]
    A measure of respiratory drive obtained from the ventilator in assist control and pressure support



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
Sampling Method:   Probability Sample
Study Population
Adult patients admitted to the medical intensive care unit and receiving mechanical ventilation
Criteria

Inclusion Criteria:

  • Patients > 18 years of age
  • intubated and mechanically ventilated for < 48 hours at the time of screening

Exclusion Criteria:

  • pregnancy
  • history of diaphragmatic paralysis
  • neuromuscular blockade
  • cardiac arrest

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): NCT04319939


Contacts
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Contact: John P Kress, MD 773-702-6404 jkress@medicine.bsd.uchicago.edu
Contact: Anne Pohlman, MSN 773-702-3804 apohlman@medicine.bsd.uchicago.edu

Locations
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United States, Illinois
The University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: John P Kress, MD    773-702-6404    jkress@medicine.bsd.uchicago.edu   
Sponsors and Collaborators
University of Chicago
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT04319939    
Other Study ID Numbers: 19-1627
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Chicago:
Diaphragm Ultrasound
Diaphragm Thickness
Control Mode Ventilation
Spontaneous Mode Ventilation