Parasympathetic Cardiovascular Function DisorderNCT03450590
Heart Rate Variability and Cardiorespiratory Complications During Ophthalmic Arterial Chemotherapy for Retinoblastoma
An observational study of Parasympathetic Cardiovascular Function Disorder, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Parasympathetic Cardiovascular Function Disorder
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Apr 2018to 9 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients undergoing ophthalmic arterial chemotherapy for retinoblastoma
Who may be able to join
- Patients undergoing ophthalmic arterial chemotherapy
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- heart rate variability, intraarterial chemotherapy, ophthalmic arterial chemotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Heart rate variability
Measured: 5 min after microcatheter enters ophthalmic artery
Secondary outcomes (2)
Heart rate variability
Heart rate variability
Measured: 5 min after anesthesia induction
Heart rate variability
Heart rate variability
Measured: 5 min before end of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start9 Apr 2018
- Primary completion9 Sep 2019
- Study completion9 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parasympathetic Cardiovascular Function DisorderStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae Kyong Kim, Seoul National University Hospital
- Investigators
- Tae Kyong Kim, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450590
- Sponsor's protocol ID
- IAchemo_HRV
- Status last verified
- Oct 2021
- First submitted
- 22 Feb 2018
- Last updated
- 4 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Heart Rate Variability and Cardiorespiratory Complications During Ophthalmic Arterial Chemotherapy for Retinoblastoma
- ClinicalTrials.gov ID
- NCT03450590
- Acronym / sponsor ID
- IAchemo_HRV
- Keywords
- heart rate variability, intraarterial chemotherapy, ophthalmic arterial chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients undergoing ophthalmic arterial chemotherapy for retinoblastoma
Key inclusion criteria (1 listed)
- Patients undergoing ophthalmic arterial chemotherapy
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart rate variability
Time frame: 5 min after microcatheter enters ophthalmic artery
Heart rate variability
2 secondary outcomes
Heart rate variability
Time frame: 5 min after anesthesia induction
Heart rate variability
Time frame: 5 min before end of anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
Related trials for Parasympathetic Cardiovascular Function Disorder
Recruiting
Comparison of Focal Cryoablation vs. Radiofrequency Cardioneuroablation for Bradyarrhythmias
Bradycardia, Syncope, Vasovagal
Enrolling by invitation
Low-frequency Electrical Stimulation for Cognitive Enhancement in Atrial Fibrillation
Cognitive Function Abnormal, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tae Kyong Kim principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parasympathetic Cardiovascular Function Disorder, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: 5 min after microcatheter enters ophthalmic artery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.