Skip to content

Testing the Reliability and Validity of the CIBA

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02882594
Enrollment
384
Registered
2016-08-30
Start date
2016-03-31
Completion date
2017-06-30
Last updated
2017-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality Improvement

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.

Interventions

BEHAVIORALObserving patient behaviors for anesthesia induction compliance

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

Sponsors

Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 13 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026