NCT07747532

Brief Summary

It is often difficult for anesthesiologists to select an ultrasound method that will give consistent results and also be a reliable way to examine the diaphragm, especially on the left side of the chest. In this study, two anesthesiologists blinded to one another's scan results, will perform ultrasound scan of the diaphragm using three different methods and the measurements will be analyzed to see the reliability of each method.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
21mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Aug 2026Jul 2028

First Submitted

Initial submission to the registry

July 21, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

August 5, 2026

Status Verified

July 1, 2026

Enrollment Period

1.6 years

First QC Date

July 21, 2026

Last Update Submit

July 30, 2026

Conditions

Diaphragm Issues

Keywords

Diaphragm ultrasoundIntra-rater analysisInter-rater analysisZone of Apposition, ZOADiaphragmatic diseasesDome of diaphragm, DODThickening Fraction, TF

Outcome Measures

Primary Outcomes (2)

  • To measure the intra-rater reliability of the excursion of the zone of apposition, (ZOA)

    To measure the intra-rater (between two measurements of the same scanner) reliability of the excursion of the ZOA using a linear probe over the lateral chest wall, quantified by Intraclass correlation coefficients (ICC).

    Through study completion, an average of 2 years

  • To measure the inter-rater reliability of the excursion of the zone of apposition, (ZOA)

    To measure the inter-rater (between two ultrasound scanners) reliability of the excursion of the zone of apposition, (ZOA) using a linear probe over the lateral chest wall, quantified by Intraclass correlation coefficients (ICC).

    Through study completion, an average of 2 years

Secondary Outcomes (7)

  • To measure the intra-rater reliability of the excursion of the dome of the diaphragm (DOD)

    Through study completion, an average of 2 years

  • To measure the inter-rater reliability of the excursion of the dome of the diaphragm (DOD)

    Through study completion, an average of 2 years

  • To measure intra-rater reliability of the Thickening Fraction, (TF) of the ZOA

    Through study completion, an average of 2 years

  • To measure inter-rater reliability of the Thickening Fraction, (TF) of the ZOA

    Through study completion, an average of 2 years

  • To measure the distribution of diaphragmatic measurements obtained for the ZOA method (Excursion of the ZOA)

    Through study completion, an average of 2 years

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient aged 18 years or over who are scheduled for any elective surgical procedure at Toronto Western Hospital or Women's College Hospital, Toronto.

You may qualify if:

  • Any elective surgical patient
  • Age ≥18 years
  • American Society of Anesthesiologists class I to III

You may not qualify if:

  • Pregnancy - patients will be asked if they are pregnant or not and screened post-consent from their medical chart.
  • History of diaphragmatic dysfunction
  • Previous surgical procedures on the lung, thorax or diaphragm.
  • Inability to understand the study activities and provide informed consent when explained about the study and the consent process
  • Refusal to participate in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital, University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

Study Officials

  • Laura Giron-Arango, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jayanta Chowdhury

CONTACT

4166035800jayanta.chowdhury@uhn.ca

Laura Giron-Arango, MD

CONTACT

4166035118laura.gironarango1@uhn.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2026

First Posted

August 5, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

August 5, 2026

Record last verified: 2026-07

Locations

CA(1)