Pediatric AnesthesiaNCT02761954
Variation of Cerebral Blood Flow in Anterior Cerebral and Basilar Artery in Neonates and Infants in Genreal Anesthesia With Caudal Block
An observational study of Pediatric Anesthesia, run by Bürgerhospital Frankfurt.
Trial summary
With this study we want to see how the blood flow in the anterior cerebral artery (ACA) and the basilar artery (BA) after the caudal block changes. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Pediatric Anesthesia
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to 20 Dec 2017
- 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 12 months
- All sexes
- No healthy volunteers
- Child
Study population: infants and neonates undergoing a infraumbilical surgery in general anesthesia with caudal block
Who may be able to join
- opened big fontanella
- infraumbilical surgery
Who cannot join
- cardiac or cerebral disease
- prior operation on vertebra, heart or head/brain
- malforamtion of head or vertebra
- closed fontanella
- contraindication for caudal block (von-Willebrand-Syndrome, haemophilia,...)
About this study
Official title: Variation of Cerebral Blood Flow in Anterior Cerebral and Basilar Artery in Neonates and Infants - a Prospective Study During Planed Surgery of the Infra Umbilical Region in Combined Anaesthesia
With this study we want to see how the blood flow in the anterior cerebral artery (ACA) and the basilar artery (BA) after the caudal block changes.
- Conditions
- Pediatric Anesthesia
- Keywords
- regional anesthesia, caudal block
What is being measured
The primary outcome is the main question the study is designed to answer.
depression of blood flow in ACA & basilar artery after caudal block
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startJan 2016
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric AnesthesiaStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bürgerhospital Frankfurt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Erceg, Bürgerhospital Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761954
- Sponsor's protocol ID
- Kaudal Studie
- Status last verified
- Jul 2018
- First submitted
- 2 May 2016
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variation of Cerebral Blood Flow in Anterior Cerebral and Basilar Artery in Neonates and Infants - a Prospective Study During Planed Surgery of the Infra Umbilical Region in Combined Anaesthesia
- ClinicalTrials.gov ID
- NCT02761954
- Acronym / sponsor ID
- Kaudal Studie
- Conditions
- Pediatric Anesthesia
- Keywords
- regional anesthesia, caudal block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bürgerhospital FrankfurtUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 4 May 2016 (estimated)
- 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.
With this study we want to see how the blood flow in the anterior cerebral artery (ACA) and the basilar artery (BA) after the caudal block changes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- infants and neonates undergoing a infraumbilical surgery in general anesthesia with caudal block
Key inclusion criteria (2 listed)
- opened big fontanella
- infraumbilical surgery
Key exclusion criteria (5 listed)
- cardiac or cerebral disease
- prior operation on vertebra, heart or head/brain
- malforamtion of head or vertebra
- closed fontanella
- contraindication for caudal block (von-Willebrand-Syndrome, haemophilia,...)
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
depression of blood flow in ACA & basilar artery after caudal block
Time frame: one hour
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 11 Jul 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Anesthesia, run by Bürgerhospital Frankfurt.
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 2 inclusion and 5 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 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
depression of blood flow in ACA & basilar artery after caudal block (time frame: one hour). 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 11 Jul 2018; AzTrials last refreshed its copy on 8 Nov 2026.