AnesthesiaNCT04947397
Investigation of Pupillometry as Guide for Extubation Readiness in Anesthetized Children
A study testing Pupillometry in people with Anesthesia and Laryngospasm on Emergence, run by University of California, San Francisco at 1 site in United States.
Trial summary
Investigation of pupillometry as guide for extubation readiness in anesthetized children. Read more about this study
- Who is it for?
- Ages 2 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Laryngospasm on Emergence
- What is being tested?
- Pupillometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2022to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children undergoing general anesthesia and endotracheal intubation for surgery.
- American Society of Anesthesiologists Physical Status Class I and II patients.
Who cannot join
- Central nervous system abnormality.
- Ophthalmologic abnormality.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
About this study
Investigation of pupillometry as guide for extubation readiness in anesthetized children.
Read the detailed description
Can a pupil metric be used to make extubation more safe in anesthetized children?
- Conditions
- Anesthesia, Laryngospasm on Emergence
- Being tested
- Pupillometry
- Keywords
- Pediatric, Anesthesia, Extubation, Pupillometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PupillometryDiagnostic test
Pupillometry prior to extubation
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | Traditional deep extubation at 1.5 minimum alveolar concentration (MAC) |
| Group 2 | Experimental | Deep extubation guided by pupillometry -- at < 0.5 MAC of vapor + propofol and fentanyl Receives: Diagnostic Test: Pupillometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation Success
Maintenance of spontaneous ventilation without pathologic airway response such as laryngospasm.
Ventilation monitored in a standard manner, using chest wall movement, capnography, reservoir bag movement, condensation of anesthetic mask and auscultation.
Measured: Immediately after extubation
Secondary outcomes (1)
Anesthetic Vapor Concentration at Extubation
Percent of end-tidal sevoflurane at extubation
Measured: At the time of extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start20 Jun 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Abelson, MD, Principal investigator, UCSF Benioff Children's Hospital Oakland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947397
- Sponsor's protocol ID
- 20-32664
- Status last verified
- Dec 2024
- First submitted
- 11 Jun 2021
- Last updated
- 22 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pupillometry as Guide for Extubation Readiness in Anesthetized Children
- ClinicalTrials.gov ID
- NCT04947397
- Acronym / sponsor ID
- 20-32664
- Conditions
- Anesthesia, Laryngospasm on Emergence
- Keywords
- Pediatric, Anesthesia, Extubation, Pupillometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 1 Jul 2021 (actual)
- Results
- Posted 22 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigation of pupillometry as guide for extubation readiness in anesthetized children.
Detailed description
Can a pupil metric be used to make extubation more safe in anesthetized children?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –Traditional deep extubation at 1.5 minimum alveolar concentration (MAC) |
| Group 2 | Experimental | Diagnostic Test: PupillometryDeep extubation guided by pupillometry -- at < 0.5 MAC of vapor + propofol and fentanyl |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children undergoing general anesthesia and endotracheal intubation for surgery.
- American Society of Anesthesiologists Physical Status Class I and II patients.
Key exclusion criteria (2 listed)
- Central nervous system abnormality.
- Ophthalmologic abnormality.
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 |
|---|---|---|
| PupillometryPupillometry prior to extubation | Diagnostic test | Group 2 |
Primary outcome
Extubation Success
Time frame: Immediately after extubation
Maintenance of spontaneous ventilation without pathologic airway response such as laryngospasm. Ventilation monitored in a standard manner, using chest wall movement, capnography, reservoir bag movement, condensation of anesthetic mask and auscultation.
1 secondary outcome
Anesthetic Vapor Concentration at Extubation
Time frame: At the time of extubation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Daniel Abelson, MD principal investigator
UCSF Benioff Children's Hospital Oakland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pupillometry in people with Anesthesia and Laryngospasm on Emergence, run by University of California, San Francisco at 1 site in United States.
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 2 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 22 Jan 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 22 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Extubation Success (time frame: Immediately after extubation). 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 22 Jan 2025.