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

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ClinicalTrials.gov Identifier: NCT03450590
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Tae Kyong Kim, Seoul National University Hospital

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
Parasympathetic Cardiovascular Function Disorder

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 Type : Observational
Estimated 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 : April 9, 2018
Estimated Primary Completion Date : March 15, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Heart rate variability [ Time Frame: 5 min after microcatheter enters ophthalmic artery ]
    Heart rate variability


Secondary Outcome Measures :
  1. Heart rate variability [ Time Frame: 5 min after anesthesia induction ]
    Heart rate variability

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



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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing ophthalmic arterial chemotherapy for retinoblastoma
Criteria

Inclusion Criteria:

  • Patients undergoing ophthalmic arterial chemotherapy

Exclusion Criteria:


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): NCT03450590


Contacts
Contact: Tae Kyong Kim 82-2-2072-2467 ktkktk@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Tae Kyong Kim, MD    82-2-2072-2467    ktkktk@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Tae Kyong Kim Seoul National University Hospital

Responsible Party: Tae Kyong Kim, Clinical assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03450590     History of Changes
Other Study ID Numbers: IAchemo_HRV
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tae Kyong Kim, Seoul National University Hospital:
heart rate variability
intraarterial chemotherapy
ophthalmic arterial chemotherapy

Additional relevant MeSH terms:
Retinoblastoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Retinal Neoplasms
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Retinal Diseases