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Heart Rate Variability and Cardiorespiratory Complications During Ophthalmic Arterial Chemotherapy for Retinoblastoma

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03450590
Collaborator
(none)
38
Enrollment
1
Location
17
Actual Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A patient undergoing ophthalmic arterial chemosurgery may experience a sudden, profound decrease in lung compliance when the microcatheter is in the ICA or ophthalmic artery. However, underlying pathophysiology of the respiratory complication is unknown. In this study, the investigators are going to investigate the relation between underlying balance of parasympathetic and sympathetic tone and the respiratory complications by analyzing heart rate beat-to-beat variability.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A patient undergoing ophthalmic arterial chemosurgery may experience a sudden, profound decrease in lung compliance when the microcatheter is in the ICA or ophthalmic artery. However, underlying pathophysiology of the respiratory complication is unknown. In this study, the investigators are going to investigate the relation between underlying balance of parasympathetic and sympathetic tone and the respiratory complications by analyzing heart rate beat-to-beat variability. Also, the investigators are going to investigate whether baseline heart rate variability can predict respiratory complications during the procedures.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    38 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Relation Between Heart Rate Variability and Cardiorespiratory Complications During Ophthalmic Arterial Chemotherapy for Retinoblastoma
    Actual Study Start Date :
    Apr 9, 2018
    Actual Primary Completion Date :
    Sep 9, 2019
    Actual Study Completion Date :
    Sep 9, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Heart rate variability [5 min after microcatheter enters ophthalmic artery]

      Heart rate variability

    Secondary Outcome Measures

    1. Heart rate variability [5 min after anesthesia induction]

      Heart rate variability

    2. Heart rate variability [5 min before end of anesthesia]

      Heart rate variability

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 20 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients undergoing ophthalmic arterial chemotherapy
    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of 03080

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Tae Kyong Kim, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tae Kyong Kim, Clinical assistant professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT03450590
    Other Study ID Numbers:
    • IAchemo_HRV
    First Posted:
    Mar 1, 2018
    Last Update Posted:
    Oct 4, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tae Kyong Kim, Clinical assistant professor, Seoul National University Hospital
    heart rate variability
    intraarterial chemotherapy
    ophthalmic arterial chemotherapy
    Additional relevant MeSH terms:
    Retinoblastoma

    Study Results

    No Results Posted as of Oct 4, 2021