Diaphragm Ultrasound Measurements With Variations in Modes of Ventilation

NCT04319939 | Completed

• 1 other identifier: IRB19-1627
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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

Conditions

Mechanical Ventilation

Keywords

Diaphragm Ultrasound; Diaphragm Thickness; Control Mode Ventilation; Spontaneous Mode Ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Thickening fraction in controlled and spontaneous modes

  Less than 48 hours after mechanical ventilation

• Variance in peak inspiration thickness in controlled and spontaneous modes

  Less than 48 hours after mechanical ventilation

• p0.1 measurements in controlled and spontaneous modes

  Less than 48 hours after mechanical ventilation

Study Arms (1)

Participants receiving mechanical ventilation

Other: Assist Control Mode and Pressure Support Mode Mechanical Ventilation

Interventions

Assist Control Mode and Pressure Support Mode Mechanical Ventilation OTHER

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.

Participants receiving mechanical ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

• 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.

  PMID: 35404772 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: March 24, 2020
• Study Start: February 5, 2020
• Primary Completion: April 11, 2022
• Study Completion: April 11, 2022
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)