Cerebral Blood FlowNCT04291326
Cerebral Blood Flow Velocity Changes During Laparoscopic Surgery
An observational study of Cerebral Blood Flow, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Little is known about how implementation of pneumoperitoneum contributes to cerebral blood flow in pediatrics. We investigated this question in patients undergoing laparoscopic surgery, hypothesizing that cardiorespiratory changes during this procedure would reduce cerebral perfusion. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Cerebral Blood Flow
- What is being tested?
- Transfontanelle ultrasound
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Mar 2020to 28 Dec 2021
- 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 2 years
- All sexes
- No healthy volunteers
- Child
Study population: pediatric patients undergoing general anesthesia for laparoscopic surgery
Who may be able to join
- pediatric patients undergoing laparoscopic surgery
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Jin-Tae Kim
Seoul
Jin-Tae Kim, MD. PhD, 82-2-2072-3664, jintae73@gmail.com
About this study
Official title: A Study on Cerebral Blood Flow Velocity Changes During Laparoscopic Surgery in Pediatric Patients: Observational Study Using Transfontanelle Ultrasound
Little is known about how implementation of pneumoperitoneum contributes to cerebral blood flow in pediatrics. We investigated this question in patients undergoing laparoscopic surgery, hypothesizing that cardiorespiratory changes during this procedure would reduce cerebral perfusion.
- Conditions
- Cerebral Blood Flow
- Being tested
- Transfontanelle ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfontanelle ultrasoundDiagnostic test
cerebral blood flow measurement using transfontanelle ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow
cerebral blood flow measurement using transfontanelle ultrasound
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start20 Mar 2020
- Primary completion28 Dec 2021 (estimated)
- Study completion28 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Blood FlowStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291326
- Sponsor's protocol ID
- 2002-036-110
- Status last verified
- Mar 2021
- First submitted
- 28 Feb 2020
- Last updated
- 16 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Cerebral Blood Flow Velocity Changes During Laparoscopic Surgery in Pediatric Patients: Observational Study Using Transfontanelle Ultrasound
- ClinicalTrials.gov ID
- NCT04291326
- Acronym / sponsor ID
- 2002-036-110
- Conditions
- Cerebral Blood Flow
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 28 Dec 2021 (estimated)
- Study completion
- 28 Dec 2021 (estimated)
- First posted
- 2 Mar 2020 (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.
Little is known about how implementation of pneumoperitoneum contributes to cerebral blood flow in pediatrics. We investigated this question in patients undergoing laparoscopic surgery, hypothesizing that cardiorespiratory changes during this procedure would reduce cerebral perfusion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatric patients undergoing general anesthesia for laparoscopic surgery
Key inclusion criteria (1 listed)
- pediatric patients undergoing laparoscopic surgery
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transfontanelle ultrasoundcerebral blood flow measurement using transfontanelle ultrasound | Diagnostic test | – |
Primary outcome
Cerebral blood flow
Time frame: intraoperative
cerebral blood flow measurement using transfontanelle ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
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 Cerebral Blood Flow, 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: status not confirmed, as of the sponsor's last update on 16 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral blood flow (time frame: intraoperative). 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 16 Mar 2021; AzTrials last refreshed its copy on 27 Oct 2026.