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Internal Carotid Artery Blood Flow in Pediatric Moyamoya Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04134221
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Hee-Soo Kim, Seoul National University Hospital

Brief Summary:
Little is known about how general anesthesia-induced decrease in cerebral blood flow in pediatric moyamoya pateints. We investigated this question in patients undergoing moyamoya surgery, hypothesizing that cardiorespiratory changes during this procedure would reduce cerebral perfusion.

Condition or disease Intervention/treatment
Carotid Artery, Internal Diagnostic Test: Ultrasound assessment

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study on Internal Carotid Artery Blood Flow Velocity in Children With Moyamoya Disease Undergoing Surgery: a Prospective Observational Study
Actual Study Start Date : October 18, 2019
Estimated Primary Completion Date : October 17, 2020
Estimated Study Completion Date : October 17, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Ultrasound assessment
    Ultrasound assessment of internal carotid artery blood flow


Primary Outcome Measures :
  1. Internal carotid artery blood flow velocity [ Time Frame: from anesthetic induction to end of surgery, an average of 5 hours ]
    ultrasound assessment of internal carotid artery blood flow velocity



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pediatric Moyamoya disease patients
Criteria

Inclusion Criteria:

  • pediatric patients undergoing encephaloduroarteriosynangiosis surgery for moyamoya disease

Exclusion Criteria:

  • cutaneous lesion on the neck

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134221


Locations
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Korea, Republic of
Hee-Soo Kim Recruiting
Seoul, Soul-t'ukpyolsi, Korea, Republic of, 03080
Contact: Hee-Soo Kim    1052878006    dami0605@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
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Responsible Party: Hee-Soo Kim, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04134221    
Other Study ID Numbers: 1910-055-106
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Moyamoya Disease
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases