Clinical trial NCT04319939: Diaphragm Ultrasound Measurements With Variations in Modes of Ventilation
Official title: Diaphragm Ultrasound Measurements With Variations in Modes of Ventilation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Mechanical Ventilation
Keywords: Diaphragm Ultrasound
Diaphragm Thickness
Control Mode Ventilation
Spontaneous Mode Ventilation
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients admitted to the medical intensive care unit and receiving mechanical 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.

Eligibility criteria: 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

Primary outcomes:
measure: End expiratory diaphragm thickness in controlled and spontaneous modes
timeFrame: Less than 48 hours after mechanical ventilation
Secondary outcomes:
measure: Thickening fraction in controlled and spontaneous modes
timeFrame: Less than 48 hours after mechanical ventilation
measure: Variance in peak inspiration thickness in controlled and spontaneous modes
timeFrame: Less than 48 hours after mechanical ventilation
measure: p0.1 measurements in controlled and spontaneous modes
timeFrame: Less than 48 hours after mechanical ventilation
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
Study officials:
References:
citation: 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.