Investigation of Pupillometry as Guide for Extubation Readiness in Anesthetized Children
Sponsor
University of California, San Francisco (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04947397
Collaborator
(none)
20
1
2
12
1.7
Study Details
Study Description
Brief Summary
Investigation of pupillometry as guide for extubation readiness in anesthetized children.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Can a pupil metric be used to make extubation more safe in anesthetized children?
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Investigation of Pupillometry as Guide for Extubation Readiness in Anesthetized Children
Anticipated Study Start Date
:
Jul 1, 2021
Anticipated Primary Completion Date
:
Jul 1, 2022
Anticipated Study Completion Date
:
Jul 1, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Group 1 Traditional deep extubation at 1.5 minimum alveolar concentration (MAC) |
|
| Experimental: Group 2 Deep extubation guided by pupillometry -- at < 0.5 MAC of vapor + propofol and fentanyl |
Diagnostic Test: Pupillometry
Pupillometry prior to extubation
|
Outcome Measures
Primary Outcome Measures
- Extubation success [Immediately after extubation]
Extubation without pathologic airway response such as laryngospasm
Secondary Outcome Measures
- Anesthetic vapor concentration at extubation [At the time of extubation]
Eligibility Criteria
Criteria
Ages Eligible for Study:
2 Years
to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Children undergoing general anesthesia and endotracheal intubation for surgery.
-
American Society of Anesthesiologists Physical Status Class I and II patients.
Exclusion Criteria:
-
Central nervous system abnormality.
-
Ophthalmologic abnormality.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCSF Benioff Children's Hospital Oakland | Oakland | California | United States | 94609 |
Sponsors and Collaborators
- University of California, San Francisco
Investigators
- Principal Investigator: Daniel Abelson, MD, UCSF Benioff Children's Hospital Oakland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT04947397
Other Study ID Numbers:
- 20-32664
First Posted:
Jul 1, 2021
Last Update Posted:
Jul 1, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by University of California, San Francisco
Additional relevant MeSH terms: