Investigation of Pupillometry as Guide for Extubation Readiness in Anesthetized Children

Not Applicable

Completed

• Conditions: Anesthesia; Laryngospasm on Emergence
• Interventions: Diagnostic Test: Pupillometry

• Registration Number: NCT04947397
• Lead Sponsor: University of California, San Francisco

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?

Study Timeline

• Study First Submitted: 2021-06-11
• Study First Submitted QC: 2021-06-23
• Study First Posted: 2021-07-01
• Study Start: 2022-06-20
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Results First Submitted: 2024-03-22
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-26
• Last Update Submitted: 2024-12-26
• Results First Posted: 2025-01-22
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Pupillometry	Deep extubation guided by pupillometry -- at \< 0.5 MAC of vapor + propofol and fentanyl

Primary Outcome Measures

Name	Time	Method
Extubation Success	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.

Secondary Outcome Measures

Name	Time	Method
Anesthetic Vapor Concentration at Extubation	At the time of extubation	Percent of end-tidal sevoflurane at extubation

Trial Locations

Locations (1)

UCSF Benioff Children's Hospital Oakland; 🇺🇸 Oakland, California, United States