Testing the Reliability and Validity of the CIBA
1 other identifier
observational
384
1 country
1
Brief Summary
The overall objective of the study is to improve the experience for pediatric patients undergoing anesthesia inductions. The specific objective for this proposal is to establish whether the CIBA tool demonstrates inter-rater reliability and concurrent validity with the Induction Compliance Checklist.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 15, 2016
CompletedFirst Posted
Study publicly available on registry
August 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedAugust 1, 2017
July 1, 2017
1.3 years
August 15, 2016
July 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Test the reliability and validity of the Child Induction Behavioral Assessment (CIBA) Tool by evaluating inter-rater reliability and concurrent reliability and validity of the CIBA tool with the already validated Induction Compliance Checklist (ICC)
two years
Study Arms (1)
CIBA Study Cohort
Patients aged 1 to 13 years undergoing inhalation inductions for general anesthesia
Interventions
Observing patient behaviors for anesthesia induction compliance so to test reliability and validity of the CIBA Tool
Eligibility Criteria
patients aged 1 to 13 years undergoing inhalation inductions for general anesthesia
You may qualify if:
- Presenting to Same Day Surgery department at CCHMC base campus for any surgical or Intervention Radiology procedure
- 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
You may not qualify if:
- Guardian unavailable to give consent
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45229-3039, United States
Related Publications (1)
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.
PMID: 30531219DERIVED
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2016
First Posted
August 30, 2016
Study Start
March 1, 2016
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
August 1, 2017
Record last verified: 2017-07