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Diaphragm Ultrasound Measurements With Variations in Modes of Ventilation

NCT ID: NCT04319939

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-05

Study Completion Date

2022-04-11

Brief Summary

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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

Detailed Description

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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.

Conditions

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Mechanical Ventilation

Keywords

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Diaphragm Ultrasound Diaphragm Thickness Control Mode Ventilation Spontaneous Mode Ventilation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants receiving mechanical ventilation

Assist Control Mode and Pressure Support Mode Mechanical Ventilation

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35404772 (View on PubMed)

Other Identifiers

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IRB19-1627

Identifier Type: -

Identifier Source: org_study_id