Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
384 participants
OBSERVATIONAL
2016-03-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CIBA Study Cohort
Patients aged 1 to 13 years undergoing inhalation inductions for general anesthesia
Observing patient behaviors for anesthesia induction compliance
Observing patient behaviors for anesthesia induction compliance so to test reliability and validity of the CIBA Tool
Interventions
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Observing patient behaviors for anesthesia induction compliance
Observing patient behaviors for anesthesia induction compliance so to test reliability and validity of the CIBA Tool
Eligibility Criteria
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Inclusion Criteria
* Ages 1-13 years old
* Male or female
* Patients of any ethnicity
* Family and participant communicate primarily in English
* Patients with normal neurocognitive development
* Patients undergoing inhalation induction using an anesthesia mask
* American Society of Anesthesiologists (ASA) physical classification status I, II, or III
* Patients who do or do not receive a premedication for anxiety
* Parent/guardian present at the induction of anesthesia
Exclusion Criteria
* Neurocognitive delays
* Tracheostomy
* Intravenous (IV) induction or nitrous sedation prior to IV induction
* Coordinators unable to observe or fully observe the induction
* CIBA assessment not completed by anesthesia provider
1 Year
13 Years
ALL
Yes
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Locations
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Cincinnati Children's Medical Center
Cincinnati, Ohio, United States
Countries
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References
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Winterberg AV, Ding L, Hill LM, Stubbeman BL, Varughese AM. Validation of a Simple Tool for Electronic Documentation of Behavioral Responses to Anesthesia Induction. Anesth Analg. 2020 Feb;130(2):472-479. doi: 10.1213/ANE.0000000000003945.
Other Identifiers
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2015-2812
Identifier Type: -
Identifier Source: org_study_id
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