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Diaphragm Ultrasound Measurements With Variations in Modes of Ventilation

Diaphragm Ultrasound Measurements With Variations in Modes of Ventilation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04319939
Enrollment
66
Registered
2020-03-24
Start date
2020-02-05
Completion date
2022-04-11
Last updated
2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation

Keywords

Diaphragm Ultrasound, Diaphragm Thickness, Control Mode Ventilation, Spontaneous Mode Ventilation

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

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.

Interventions

OTHERAssist 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.

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
End expiratory diaphragm thickness in controlled and spontaneous modesLess than 48 hours after mechanical ventilationDiaphragm ultrasound measurement at end expiration in assist control mode and pressure support mode

Secondary

MeasureTime frameDescription
Thickening fraction in controlled and spontaneous modesLess than 48 hours after mechanical ventilationDiaphragm 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
Variance in peak inspiration thickness in controlled and spontaneous modesLess than 48 hours after mechanical ventilationDiaphragm ultrasound measurement at peak inspiration in assist control and pressure support
p0.1 measurements in controlled and spontaneous modesLess than 48 hours after mechanical ventilationA measure of respiratory drive obtained from the ventilator in assist control and pressure support

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026