Reliability of Diaphragm Ultrasound: Intra- and Interrater Analysis
ConditionDiaphragm Issues
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Any elective surgical patient
Age ≥18 years
American Society of Anesthesiologists class I to III
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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).
Time frame
Through study completion, an average of 2 years2
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).
Time frame
Through study completion, an average of 2 yearsSecondary outcomes
1
To measure the intra-rater reliability of the excursion of the dome of the diaphragm (DOD)
To 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
Time frame
Through study completion, an average of 2 years2
To measure the inter-rater reliability of the excursion of the dome of the diaphragm (DOD)
To 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
Time frame
Through study completion, an average of 2 years3
To measure intra-rater reliability of the Thickening Fraction, (TF) of the ZOA
To 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.
Time frame
Through study completion, an average of 2 years4
To measure inter-rater reliability of the Thickening Fraction, (TF) of the ZOA
To 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.
Time frame
Through study completion, an average of 2 yearsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: