Testing the Reliability and Validity of the CIBA

Quality Improvement Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02882594
• Other study ID #: 2015-2812
• Status: Completed
• Phase: N/A
• First received: August 15, 2016
• Last updated: July 28, 2017
• Start date: March 2016
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Quality Improvement

Intervention

Behavioral:
• Observing patient behaviors for anesthesia induction compliance
Observing patient behaviors for anesthesia induction compliance so to test reliability and validity of the CIBA Tool

Locations

Country	Name	City	State
United States	Cincinnati Children's Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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