Diaphragm Ultrasound Measurements With Variations in Modes of Ventilation

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. For patients receiving sedatives, an additional set of measurements will be taken during a standard of care interruption of sedatives

Study Overview

• Status: Active, not recruiting
• Conditions: Mechanical Ventilation
• Intervention / Treatment: 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. In patients receiving sedatives, additional measurements will be taken after an interruption of sedatives. Measurements will be compared between modes and on assist-control before and after an interruption of sedatives.

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.

• Study Type: Observational
• Enrollment (Estimated): 66

Contacts and Locations

• Study Contact: Name: John P Kress, MD; Phone Number: 773-702-6404; Email: jkress@medicine.bsd.uchicago.edu
• Study Contact Backup: Name: Anne Pohlman, MSN; Phone Number: 773-702-3804; Email: apohlman@medicine.bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients admitted to the medical intensive care unit and receiving mechanical ventilation

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End expiratory diaphragm thickness in controlled and spontaneous modes	Diaphragm ultrasound measurement at end expiration in assist control mode and pressure support mode	Less than 48 hours after mechanical ventilation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thickening fraction in controlled and spontaneous modes	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	Less than 48 hours after mechanical ventilation
Variance in peak inspiration thickness in controlled and spontaneous modes	Diaphragm ultrasound measurement at peak inspiration in assist control and pressure support	Less than 48 hours after mechanical ventilation
p0.1 measurements in controlled and spontaneous modes	A measure of respiratory drive obtained from the ventilator in assist control and pressure support	Less than 48 hours after mechanical ventilation

Collaborators and Investigators

• Sponsor: University of Chicago

Publications and helpful links

General Publications

• Pearson SD, Lin J, Stutz MR, Lecompte-Osorio P, Pohlman AS, Wolfe KS, Hall JB, Kress JP, Patel BK. Immediate Effect of Mechanical Ventilation Mode and Sedative Infusion on Measured Diaphragm Thickness. Ann Am Thorac Soc. 2022 Sep;19(9):1543-1550. doi: 10.1513/AnnalsATS.202111-1280OC.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Diaphragm Ultrasound; Diaphragm Thickness; Control Mode Ventilation; Spontaneous Mode Ventilation
• Other Study ID Numbers: IRB19-1627

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No