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Trial Outcomes & Findings for Investigation of Pupillometry as Guide for Extubation Readiness in Anesthetized Children (NCT NCT04947397)

NCT ID: NCT04947397

Last Updated: 2025-01-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Immediately after extubation

Results posted on

2025-01-22

Participant Flow

Participant milestones

Participant milestones
Measure
Group 1
Traditional deep extubation at 1.5 minimum alveolar concentration (MAC)
Group 2
Deep extubation guided by pupillometry -- at \< 0.5 MAC of vapor + propofol and fentanyl Pupillometry: Pupillometry prior to extubation
Overall Study
STARTED
10
10
Overall Study
COMPLETED
10
10
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Not collected because not relevant. Pupillometry is not considered dependent on whether male or female.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Group 1
n=10 Participants
Traditional deep extubation at 1.5 minimum alveolar concentration (MAC)
Group 2
n=10 Participants
Deep extubation guided by pupillometry -- at \< 0.5 MAC of vapor + propofol and fentanyl Pupillometry: Pupillometry prior to extubation
Total
n=20 Participants
Total of all reporting groups
Age, Continuous
4.4 years
STANDARD_DEVIATION 2.9 • n=10 Participants
5.5 years
STANDARD_DEVIATION 3.2 • n=10 Participants
5.0 years
STANDARD_DEVIATION 3.0 • n=20 Participants
Sex: Female, Male
Female
0 Participants
Not collected because not relevant. Pupillometry is not considered dependent on whether male or female.
0 Participants
Not collected because not relevant. Pupillometry is not considered dependent on whether male or female.
0 Participants
Not collected because not relevant. Pupillometry is not considered dependent on whether male or female.
Sex: Female, Male
Male
0 Participants
Not collected because not relevant. Pupillometry is not considered dependent on whether male or female.
0 Participants
Not collected because not relevant. Pupillometry is not considered dependent on whether male or female.
0 Participants
Not collected because not relevant. Pupillometry is not considered dependent on whether male or female.
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
10 participants
n=10 Participants
10 participants
n=10 Participants
20 participants
n=20 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Group 1
n=10 Participants
Traditional deep extubation at 1.5 minimum alveolar concentration (MAC)
Group 2
n=10 Participants
Deep extubation guided by pupillometry -- at \< 0.5 MAC of vapor + propofol and fentanyl Pupillometry: Pupillometry prior to extubation
Extubation Success
10 Participants
10 Participants

SECONDARY outcome

Timeframe: At the time of extubation

Percent of end-tidal sevoflurane at extubation

Outcome measures

Outcome measures
Measure
Group 1
n=10 Participants
Traditional deep extubation at 1.5 minimum alveolar concentration (MAC)
Group 2
n=10 Participants
Deep extubation guided by pupillometry -- at \< 0.5 MAC of vapor + propofol and fentanyl Pupillometry: Pupillometry prior to extubation
Anesthetic Vapor Concentration at Extubation
3.8 Percent of sevoflurane
Standard Deviation 0
0.8 Percent of sevoflurane
Standard Deviation 0.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Prior to extubation

Measurement tool: Capnogram

Outcome measures

Outcome data not reported

Adverse Events

Group 1

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group 2

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel Abelson

University of California San Francisco

Phone: 510 428 3000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place