Testing the Reliability and Validity of the CIBA

July 28, 2017 updated by: Children's Hospital Medical Center, Cincinnati
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

384

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229-3039
        • Cincinnati Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 13 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients aged 1 to 13 years undergoing inhalation inductions for general anesthesia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CIBA Study Cohort
Patients aged 1 to 13 years undergoing inhalation inductions for general anesthesia
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time 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)
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

August 15, 2016

First Submitted That Met QC Criteria

August 24, 2016

First Posted (Estimate)

August 30, 2016

Study Record Updates

Last Update Posted (Actual)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 28, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-2812

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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