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Investigation of pupillometry as guide for extubation readiness in anesthetized children.
Can a pupil metric be used to make extubation more safe in anesthetized children?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pupillometry | Diagnostic Test | Pupillometry prior to extubation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Anesthetic Vapor Concentration at Extubation | Percent of end-tidal sevoflurane at extubation | At the time of extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Breath-holding | Measurement tool: Capnogram | Prior to extubation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Abelson, MD | UCSF Benioff Children's Hospital Oakland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Benioff Children's Hospital Oakland | Oakland | California | 94609 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Traditional deep extubation at 1.5 minimum alveolar concentration (MAC) |
| FG001 | Group 2 | Deep extubation guided by pupillometry -- at < 0.5 MAC of vapor + propofol and fentanyl Pupillometry: Pupillometry prior to extubation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Traditional deep extubation at 1.5 minimum alveolar concentration (MAC) |
| BG001 | Group 2 | Deep extubation guided by pupillometry -- at < 0.5 MAC of vapor + propofol and fentanyl Pupillometry: Pupillometry prior to extubation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age range: 2 years old through 10 years old |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Immediately after extubation |
|
Data were collected over the time period spanning extubation to discharge from the PACU, a time range of 1 to 3 hours.
Extubation of the trachea in pediatric anesthesia has inherent risks. Risks include airway compromise secondary to laryngospasm, bronchospasm or other forms of airway obstruction.
When severe, airway compromise can lead to cardiac arrest.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Traditional deep extubation at 1.5 minimum alveolar concentration (MAC) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Abelson | University of California San Francisco | 510 428 3000 | daniel.abelson@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2024 | Dec 26, 2024 | Prot_SAP_003.pdf |
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| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Not collected because not relevant. Pupillometry is not considered dependent on whether male or female. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Anesthetic Vapor Concentration at Extubation | Percent of end-tidal sevoflurane at extubation | Posted | Mean | Standard Deviation | Percent of sevoflurane | At the time of extubation |
|
|
|
| Other Pre-specified | Breath-holding | Measurement tool: Capnogram | Not Posted | Prior to extubation | Participants |
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Group 2 | Deep extubation guided by pupillometry -- at < 0.5 MAC of vapor + propofol and fentanyl Pupillometry: Pupillometry prior to extubation | 0 | 10 | 0 | 10 | 0 | 10 |
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