Cerebral LesionNCT05391282
Internal Carotid Artery Blood Flow in Infants With Prone Position
An observational study of Cerebral Lesion, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Little is known about how implementation of prone position contributes to general anesthesia-induced decrease in cerebral blood flow in infants. The investigators investigated this question in participants undergoing untethering, hypothesizing that cardiorespiratory changes during this procedure would reduce cerebral… Read more about this study
- Who is it for?
- Ages Up to 15 months
- Conditions the study is for
- Cerebral Lesion
- What is being tested?
- ultrasound assessment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 May 2022to 23 Dec 2023
- 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 15 months
- All sexes
- No healthy volunteers
- Child
Study population: pediatric neurosurgical patients
Who may be able to join
- pediatric neurosurgical patients receiving surgery under prone position
Who cannot join
- patients diagnosed as hydrocephalus
- premature closure of fontanelle
- patients diagnosed as patent ductus arteriosus or other congenital heart disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on Internal Carotid Artery Blood Flow Velocity Changes in Prone, Head Tilt and Trendelenberg Position in Infants: an Observational Study Using Transfontanel Ultrasound
Little is known about how implementation of prone position contributes to general anesthesia-induced decrease in cerebral blood flow in infants. The investigators investigated this question in participants undergoing untethering, hypothesizing that cardiorespiratory changes during this procedure would reduce cerebral perfusion.
- Conditions
- Cerebral Lesion
- Being tested
- ultrasound assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound assessmentOther
Transfontanel ultrasound assessment before and after prone positioning
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of internal carotid artery blood flow velocity
Measured: from induction of anesthesia to end of operation, about 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start23 May 2022 (estimated)
- Primary completion23 Dec 2023 (estimated)
- Study completion23 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral LesionStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun-hee Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391282
- Sponsor's protocol ID
- 2204-162-1320
- Status last verified
- May 2022
- First submitted
- 20 May 2022
- Last updated
- 31 May 2022
- 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 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Internal Carotid Artery Blood Flow Velocity Changes in Prone, Head Tilt and Trendelenberg Position in Infants: an Observational Study Using Transfontanel Ultrasound
- ClinicalTrials.gov ID
- NCT05391282
- Acronym / sponsor ID
- 2204-162-1320
- Conditions
- Cerebral Lesion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 23 May 2022 (estimated)
- Primary completion
- 23 Dec 2023 (estimated)
- Study completion
- 23 Dec 2023 (estimated)
- First posted
- 25 May 2022 (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 prone position contributes to general anesthesia-induced decrease in cerebral blood flow in infants. The investigators investigated this question in participants undergoing untethering, 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 15 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatric neurosurgical patients
Key inclusion criteria (1 listed)
- pediatric neurosurgical patients receiving surgery under prone position
Key exclusion criteria (3 listed)
- patients diagnosed as hydrocephalus
- premature closure of fontanelle
- patients diagnosed as patent ductus arteriosus or other congenital heart disease.
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 |
|---|---|---|
| ultrasound assessmentTransfontanel ultrasound assessment before and after prone positioning | Other | – |
Primary outcome
Changes of internal carotid artery blood flow velocity
Time frame: from induction of anesthesia to end of operation, about 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- 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 Lesion, 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 3 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 31 May 2022. 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?
Contact Eun-hee Kim (+82-2-2072-3664, beloveun@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of internal carotid artery blood flow velocity (time frame: from induction of anesthesia to end of operation, about 3 hours). 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 31 May 2022.