Investigation of Pupillometry as Guide for Extubation Readiness in Anesthetized Children

December 19, 2023 updated by: University of California, San Francisco
Investigation of pupillometry as guide for extubation readiness in anesthetized children.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Can a pupil metric be used to make extubation more safe in anesthetized children?

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extubation success
Time Frame: Immediately after extubation
Extubation without pathologic airway response such as laryngospasm
Immediately after extubation

Secondary Outcome Measures

Outcome Measure
Time Frame
Anesthetic vapor concentration at extubation
Time Frame: At the time of extubation
At the time of extubation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breath-holding
Time Frame: Prior to extubation
Measurement tool: Capnogram
Prior to extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Daniel Abelson, MD, UCSF Benioff Children's Hospital Oakland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2022

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

June 11, 2021

First Submitted That Met QC Criteria

June 23, 2021

First Posted (Actual)

July 1, 2021

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-32664

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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