Reliability of Diaphragm Ultrasound: Intra- and Interrater Analysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diaphragm Issues. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- To measure the intra-rater reliability of the excursion of the zone of apposition, (ZOA) [Time frame: Through study completion, an average of 2 years]
- To measure the inter-rater reliability of the excursion of the zone of apposition, (ZOA) [Time frame: Through study completion, an average of 2 years]
Secondary outcome measures (7)
- To measure the intra-rater reliability of the excursion of the dome of the diaphragm (DOD) [Time frame: Through study completion, an average of 2 years]
- To measure the inter-rater reliability of the excursion of the dome of the diaphragm (DOD) [Time frame: Through study completion, an average of 2 years]
- To measure intra-rater reliability of the Thickening Fraction, (TF) of the ZOA [Time frame: Through study completion, an average of 2 years]
- To measure inter-rater reliability of the Thickening Fraction, (TF) of the ZOA [Time frame: Through study completion, an average of 2 years]
- To measure the distribution of diaphragmatic measurements obtained for the ZOA method (Excursion of the ZOA) [Time frame: Through study completion, an average of 2 years]
- To measure the distribution of diaphragmatic measurements obtained for the DOD method [Time frame: Through study completion, an average of 2 years]
- To measure the distribution of diaphragmatic measurements obtained for the Thickening Fraction method (TF of the ZOA) [Time frame: Through study completion, an average of 2 years]
Eligibility criteria
Inclusion criteria
Participants must meet all the following inclusion criteria to be eligible for the study:
- Any elective surgical patient
- Age ≥18 years
- American Society of Anesthesiologists class I to III
Exclusion criteria
Participants will not be eligible for the study if any of the exclusion criteria is present:
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- Toronto Western Hospital, University Health Network — Toronto
Identifiers
NCT: NCT07747532 · 26-5084