Investigation of Pupillometry as Guide for Extubation Readiness in Anesthetized Children

NCT04947397 | Completed Results DMC FDA Device

• 1 other identifier: 20-32664
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Investigation of pupillometry as guide for extubation readiness in anesthetized children.

Conditions

Anesthesia; Laryngospasm on Emergence

Keywords

Pediatric; Anesthesia; Extubation; Pupillometry

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately after extubation

Secondary Outcomes (1)

• Anesthetic Vapor Concentration at Extubation

  At the time of extubation

Other Outcomes (1)

• Breath-holding

  Prior to extubation

Study Arms (2)

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

Diagnostic Test: Pupillometry

Interventions

Pupillometry DIAGNOSTIC_TEST

Pupillometry prior to extubation

Group 2

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children undergoing general anesthesia and endotracheal intubation for surgery.
• American Society of Anesthesiologists Physical Status Class I and II patients.

You may not qualify if:

• Central nervous system abnormality.
• Ophthalmologic abnormality.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609, United States

Location

Results Point of Contact

• Title: Daniel Abelson
• Organization: University of California San Francisco

daniel.abelson@ucsf.edu

510 428 3000

Study Officials

• Daniel Abelson, MD

  UCSF Benioff Children's Hospital Oakland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: July 1, 2021
• Study Start: June 20, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: January 22, 2025
• Results First Posted: January 22, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)