Diaphragm Ultrasound Measurements With Variations in Modes of Ventilation

Mechanical Ventilation Clinical Trial

Official title:

Diaphragm Ultrasound Measurements With Variations in Modes of Ventilation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04319939
• Other study ID #: IRB19-1627
• Status: Active, not recruiting
• Start date: February 5, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 66
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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