Skip to content

Reliability of Diaphragm Ultrasound: Intra- and Interrater Analysis

Reliability of Diaphragm Ultrasound: Intra- and Interrater Analysis

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07747532
Acronym
ReDU analysis
Enrollment
58
Registered
2026-08-05
Start date
2026-08-01
Completion date
2028-07-01
Last updated
2026-08-05

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

Conditions

Diaphragm Issues

Keywords

Diaphragm ultrasound, Intra-rater analysis, Inter-rater analysis, Zone of Apposition, ZOA, Diaphragmatic diseases, Dome of diaphragm, DOD, Thickening Fraction, TF

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.

Detailed description

Ultrasound assessment of the diaphragm is a portable and non-invasive option for assessing and monitoring diaphragmatic function. The diaphragm is the main muscle used for breathing. It is a muscular organ that lies in between the thorax (chest) and abdomen. By moving up and down, it helps in our breathing by aiding both the right and the left lung to inflate and deflate. Assessing diaphragmatic function provides meaningful information in the setting of chronic lung diseases, obesity and diseases of nerve and muscle dysfunction and in assessing the diaphragmatic function before and after surgery. However, ultrasound assessment of the diaphragm on the left side of chest is sometimes difficult or impossible in a large proportion of patients. There are currently three ultrasound methods to examine the diaphragm, and to date, it is not clear which technique should be used as the most reliable method. The purpose of this research study is to find out how much reliable the different ultrasound methods are in assessing the movement of the diaphragm during respiration. 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. The investigators believe that the results of this study can guide medical professionals in selecting an ultrasound method that will give consistent results and a more reliable way to examine the diaphragm, especially on the left side of the chest.

Interventions

None listed

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Participants must meet all the following inclusion criteria to be eligible for the study: 1. Any elective surgical patient 2. Age ≥18 years 3. American Society of Anesthesiologists class I to III

Exclusion criteria

Participants will not be eligible for the study if any of the

Design outcomes

Primary

MeasureTime frameDescription
To measure the intra-rater reliability of the excursion of the zone of apposition, (ZOA)Through study completion, an average of 2 yearsTo 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).
To measure the inter-rater reliability of the excursion of the zone of apposition, (ZOA)Through study completion, an average of 2 yearsTo 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).

Secondary

MeasureTime frameDescription
To measure the intra-rater reliability of the excursion of the dome of the diaphragm (DOD)Through study completion, an average of 2 yearsTo measure the intra-rater (between two measurements of the same scanner) reliability of the excursion of the DOD measured using a curvilinear probe via the subcostal abdominal window, quantified by ICCs
To measure the inter-rater reliability of the excursion of the dome of the diaphragm (DOD)Through study completion, an average of 2 yearsTo measure the inter-rater (between two ultrasound scanners) reliability of the excursion of the DOD measured using a curvilinear probe via the subcostal abdominal window, quantified by ICCs
To measure intra-rater reliability of the Thickening Fraction, (TF) of the ZOAThrough study completion, an average of 2 yearsTo measure intra-rater (between two measurements of the same scanner) reliability of the Thickening Fraction, TF of the ZOA measured using a linear probe over the lateral chest wall, quantified by ICCs.
To measure inter-rater reliability of the Thickening Fraction, (TF) of the ZOAThrough study completion, an average of 2 yearsTo measure inter-rater (between two ultrasound scanners) reliability of the Thickening Fraction, (TF) of the ZOA measured using a linear probe over the lateral chest wall, quantified by ICCs.
To measure the distribution of diaphragmatic measurements obtained for the ZOA method (Excursion of the ZOA)Through study completion, an average of 2 yearsTo measure the distribution of diaphragmatic measurements obtained for the ZOA method (Excursion of the ZOA) using F-tests for ICCs
To measure the distribution of diaphragmatic measurements obtained for the DOD methodThrough study completion, an average of 2 yearsTo measure the distribution of diaphragmatic measurements obtained using the DOD method (Excursion of the DOD) using F-tests for ICCs
To measure the distribution of diaphragmatic measurements obtained for the Thickening Fraction method (TF of the ZOA)Through study completion, an average of 2 yearsTo measure the distribution of diaphragmatic measurements obtained for the Thickening fraction method (TF of the ZOA) using F-tests for ICCs

Countries

Canada

Contacts

CONTACTJayanta Chowdhury
jayanta.chowdhury@uhn.ca4166035800
CONTACTLaura Giron-Arango, MD
laura.gironarango1@uhn.ca4166035118
PRINCIPAL_INVESTIGATORLaura Giron-Arango, MD

University Health Network, Toronto

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026