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

October 1, 2021 updated by: Tae Kyong Kim, Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing ophthalmic arterial chemotherapy for retinoblastoma

Description

Inclusion Criteria:

  • Patients undergoing ophthalmic arterial chemotherapy

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate variability
Time Frame: 5 min after microcatheter enters ophthalmic artery
Heart rate variability
5 min after microcatheter enters ophthalmic artery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate variability
Time Frame: 5 min after anesthesia induction
Heart rate variability
5 min after anesthesia induction
Heart rate variability
Time Frame: 5 min before end of anesthesia
Heart rate variability
5 min before end of anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2018

Primary Completion (Actual)

September 9, 2019

Study Completion (Actual)

September 9, 2019

Study Registration Dates

First Submitted

February 22, 2018

First Submitted That Met QC Criteria

February 28, 2018

First Posted (Actual)

March 1, 2018

Study Record Updates

Last Update Posted (Actual)

October 4, 2021

Last Update Submitted That Met QC Criteria

October 1, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAchemo_HRV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parasympathetic Cardiovascular Function Disorder

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe