Clinical trial NCT02882594: Testing the Reliability and Validity of the CIBA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality Improvement
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 384
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients aged 1 to 13 years undergoing inhalation inductions for general anesthesia

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.

Detailed description: The proposed research study will assess the reliability and validity of a new tool that is being used in the Department of Anesthesia (The Child Induction Behavioral Assessment tool) to grade the difficulty of patient behaviors exhibited during anesthesia inductions. The Child Induction Behavioral Assessment (CIBA) tool is more succinct than previously validated tools for assessing behavioral responses to inhalation inductions, making it practical for use in a busy clinical practice setting. Having clinicians document a patient's behavioral response to induction using the CIBA tool is useful because this information can help to optimize subsequent induction plans if the patient returns. Additionally, population data may be collected using electronic data reports for QI purposes. Prior to using data from the CIBA tool in QI initiatives, it is important to assess whether this tool is reliable and valid.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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)
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Medical Center
state: Ohio
Study officials:
References:
citation: 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.