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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03450590
Other study ID # IAchemo_HRV
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 9, 2018
Est. completion date September 9, 2019

Study information

Verified date October 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date September 9, 2019
Est. primary completion date September 9, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 20 Years
Eligibility Inclusion Criteria: - Patients undergoing ophthalmic arterial chemotherapy Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Heart rate variability Heart rate variability 5 min after microcatheter enters ophthalmic artery
Secondary Heart rate variability Heart rate variability 5 min after anesthesia induction
Secondary Heart rate variability Heart rate variability 5 min before end of anesthesia