Mechanical VentilationNCT04319939
Diaphragm Ultrasound Measurements With Variations in Modes of Ventilation
An observational study of Mechanical Ventilation, run by University of Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2020to 11 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients admitted to the medical intensive care unit and receiving mechanical ventilation
Who may be able to join
- Patients > 18 years of age
- intubated and mechanically ventilated for < 48 hours at the time of screening
Who cannot join
- pregnancy
- history of diaphragmatic paralysis
- neuromuscular blockade
- cardiac arrest
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
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
Read the 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.
- Conditions
- Mechanical Ventilation
- Being tested
- Assist Control Mode and Pressure Support Mode Mechanical Ventilation
- Keywords
- Diaphragm Ultrasound, Diaphragm Thickness, Control Mode Ventilation, Spontaneous Mode Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assist Control Mode and Pressure Support Mode Mechanical VentilationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving mechanical ventilation | Not described Receives: Other: Assist Control Mode and Pressure Support Mode Mechanical Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
End expiratory diaphragm thickness in controlled and spontaneous modes
Diaphragm ultrasound measurement at end expiration in assist control mode and pressure support mode
Measured: Less than 48 hours after mechanical ventilation
Secondary outcomes (3)
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
Measured: Less than 48 hours after mechanical ventilation
Variance in peak inspiration thickness in controlled and spontaneous modes
Diaphragm ultrasound measurement at peak inspiration in assist control and pressure support
Measured: Less than 48 hours after mechanical ventilation
p0.1 measurements in controlled and spontaneous modes
A measure of respiratory drive obtained from the ventilator in assist control and pressure support
Measured: Less than 48 hours after mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start5 Feb 2020
- Primary completion11 Apr 2022
- Study completion11 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319939
- Sponsor's protocol ID
- IRB19-1627
- Status last verified
- Dec 2025
- First submitted
- 16 Jan 2020
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35404772
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragm Ultrasound Measurements With Variations in Modes of Ventilation
- ClinicalTrials.gov ID
- NCT04319939
- Acronym / sponsor ID
- IRB19-1627
- Conditions
- Mechanical Ventilation
- Keywords
- Diaphragm Ultrasound, Diaphragm Thickness, Control Mode Ventilation, Spontaneous Mode Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving mechanical ventilation | – | Other: Assist Control Mode and Pressure Support Mode Mechanical Ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the medical intensive care unit and receiving mechanical ventilation
Key inclusion criteria (2 listed)
- Patients > 18 years of age
- intubated and mechanically ventilated for < 48 hours at the time of screening
Key exclusion criteria (4 listed)
- pregnancy
- history of diaphragmatic paralysis
- neuromuscular blockade
- cardiac arrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assist Control Mode and Pressure Support Mode Mechanical VentilationDiaphragm 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. | Other | Participants receiving mechanical ventilation |
Primary outcome
End expiratory diaphragm thickness in controlled and spontaneous modes
Time frame: Less than 48 hours after mechanical ventilation
Diaphragm ultrasound measurement at end expiration in assist control mode and pressure support mode
3 secondary outcomes
Thickening fraction in controlled and spontaneous modes
Time frame: Less than 48 hours after mechanical ventilation
Variance in peak inspiration thickness in controlled and spontaneous modes
Time frame: Less than 48 hours after mechanical ventilation
p0.1 measurements in controlled and spontaneous modes
Time frame: Less than 48 hours after mechanical ventilation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Derived from this study: PubMed 35404772Pearson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End expiratory diaphragm thickness in controlled and spontaneous modes (time frame: Less than 48 hours after mechanical ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04319939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.