Investigation of Pupillometry as Guide for Extubation Readiness in Anesthetized Children
Primary Purpose
Anesthesia, Laryngospasm on Emergence
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pupillometry
Sponsored by
About this trial
This is an interventional prevention trial for Anesthesia focused on measuring Pediatric, Anesthesia, Extubation, Pupillometry
Eligibility Criteria
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.
Sites / Locations
- UCSF Benioff Children's Hospital OaklandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Group 1
Group 2
Arm Description
Traditional deep extubation at 1.5 minimum alveolar concentration (MAC)
Deep extubation guided by pupillometry -- at < 0.5 MAC of vapor + propofol and fentanyl
Outcomes
Primary Outcome Measures
Extubation success
Extubation without pathologic airway response such as laryngospasm
Secondary Outcome Measures
Anesthetic vapor concentration at extubation
Full Information
NCT ID
NCT04947397
First Posted
June 11, 2021
Last Updated
September 22, 2022
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT04947397
Brief Title
Investigation of Pupillometry as Guide for Extubation Readiness in Anesthetized Children
Official Title
Investigation of Pupillometry as Guide for Extubation Readiness in Anesthetized Children
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Laryngospasm on Emergence
Keywords
Pediatric, Anesthesia, Extubation, Pupillometry
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
No Intervention
Arm Description
Traditional deep extubation at 1.5 minimum alveolar concentration (MAC)
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Deep extubation guided by pupillometry -- at < 0.5 MAC of vapor + propofol and fentanyl
Intervention Type
Diagnostic Test
Intervention Name(s)
Pupillometry
Intervention Description
Pupillometry prior to extubation
Primary Outcome Measure Information:
Title
Extubation success
Description
Extubation without pathologic airway response such as laryngospasm
Time Frame
Immediately after extubation
Secondary Outcome Measure Information:
Title
Anesthetic vapor concentration at extubation
Time Frame
At the time of extubation
Other Pre-specified Outcome Measures:
Title
Breath-holding
Description
Measurement tool: Capnogram
Time Frame
Prior to extubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Abelson, MD
Phone
(510) 428-3070
Email
daniel.abelson@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Abelson, MD
Organizational Affiliation
UCSF Benioff Children's Hospital Oakland
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Benioff Children's Hospital Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Abelson
Email
daniel.abelson@ucsf.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Investigation of Pupillometry as Guide for Extubation Readiness in Anesthetized Children
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