Testing the Reliability and Validity of the CIBA

NCT ID: NCT02882594

Last Updated: 2017-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

384 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-06-30

Brief Summary

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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

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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.

Conditions

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Quality Improvement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CIBA Study Cohort

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

Observing patient behaviors for anesthesia induction compliance

Intervention Type BEHAVIORAL

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

Interventions

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Observing patient behaviors for anesthesia induction compliance

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cincinnati Children's Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30531219 (View on PubMed)

Other Identifiers

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2015-2812

Identifier Type: -

Identifier Source: org_study_id

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