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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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18 September 2023 |
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Main ID: |
NCT03225508 |
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Date of registration:
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19/07/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Diaphragmatic Motion Using Linear Ultrasound
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Scientific title:
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A Novel Method to Measure Diaphragmatic Motion and Excursion |
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Date of first enrolment:
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August 1, 2017 |
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Target sample size:
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175 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03225508 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Canada
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Contacts
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Name:
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Anahi Perlas, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Health Network, Toronto |
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Name:
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Anahi Perlas, MD |
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Address:
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Telephone:
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4166035118 |
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Email:
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anahi.perlas@uhn.ca |
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Affiliation:
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Name:
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Jayanta Chowdhury |
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Address:
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Telephone:
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Email:
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jayanta.chowdhury@uhn.ca |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Phase 1 Any healthy adult patient undergoing elective surgery
Phase 2 Any adult patient, undergoing elective upper limb surgery that involves an
interscalene or supraclavicular brachial plexus block.
Exclusion Criteria:
(i) Inability to obtain an informed consent (e.g. language barrier) (ii) BMI > 35 (iii)
Known pre-existing diaphragmatic dysfunction (iv) Existing lung pathology
1. Smoker
2. Known abnormal pulmonary function tests
3. Severe pulmonary disease e.g., COPD, asthma, pulmonary fibrosis, or any other
significant respiratory disease that would adversely affect diaphragm function or
pulmonary function tests
Additional Criteria for Phase 2 Any contraindication to an interscalene or supraclavicular
brachial plexus block
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Examination of Diaphragm Movement Using Ultrasound
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Diaphragm; Movement
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Intervention(s)
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Diagnostic Test: Linear Ultrasound to Measure Diaphragmatic Movement
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Diagnostic Test: Pulmonary function tests
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Diagnostic Test: Curvilinear Ultrasound to Measure Diaphragmatic Movement
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Primary Outcome(s)
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Time taken to measure diaphragmatic excursion
[Time Frame: 60 minutes]
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Secondary Outcome(s)
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Quantify and compare the reduction in diaphragmatic motion following a phrenic nerve block
[Time Frame: 2 hours]
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Normal range of values for diaphragmatic excursion using linear ultrasound
[Time Frame: 30 mins]
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Success rate of measuring both the left and right hemi-diaphragmatic movement
[Time Frame: 60 mins]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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