Testing the Reliability and Validity of the CIBA

Completed

• Conditions: Quality Improvement
• Interventions: Behavioral: Observing patient behaviors for anesthesia induction compliance

• Registration Number: NCT02882594
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-08-24
• Study First Posted: 2016-08-30
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-28
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 384

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CIBA Study Cohort	Observing patient behaviors for anesthesia induction compliance	Patients aged 1 to 13 years undergoing inhalation inductions for general anesthesia

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cincinnati Children's Medical Center; 🇺🇸 Cincinnati, Ohio, United States