Quality ImprovementNCT02882594
Testing the Reliability and Validity of the CIBA
An observational study of Quality Improvement, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 year to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality Improvement
- What is being tested?
- Observing patient behaviors for anesthesia induction compliance
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 384 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: patients aged 1 to 13 years undergoing inhalation inductions for general anesthesia
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45229-3039
About this study
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.
Read the 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.
- Conditions
- Quality Improvement
- Being tested
- Observing patient behaviors for anesthesia induction compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observing patient behaviors for anesthesia induction complianceBehavioural
Observing patient behaviors for anesthesia induction compliance so to test reliability and validity of the CIBA Tool
| Study group | Role | What they receive |
|---|---|---|
| CIBA Study Cohort | Patients aged 1 to 13 years undergoing inhalation inductions for general anesthesia Receives: Behavioral: Observing patient behaviors for anesthesia induction compliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality ImprovementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882594
- Sponsor's protocol ID
- 2015-2812
- Status last verified
- Jul 2017
- First submitted
- 15 Aug 2016
- Last updated
- 1 Aug 2017
- Results posted
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30531219
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Reliability and Validity of the CIBA
- ClinicalTrials.gov ID
- NCT02882594
- Acronym / sponsor ID
- 2015-2812
- Conditions
- Quality Improvement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CIBA Study Cohort | – | Behavioral: Observing patient behaviors for anesthesia induction compliancePatients aged 1 to 13 years undergoing inhalation inductions for general anesthesia |
Who may qualify
- Ages
- 1 year to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- patients aged 1 to 13 years undergoing inhalation inductions for general anesthesia
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observing patient behaviors for anesthesia induction complianceObserving patient behaviors for anesthesia induction compliance so to test reliability and validity of the CIBA Tool | Behavioural | CIBA Study Cohort |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Derived from this study: PubMed 30531219Winterberg 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality Improvement, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02882594, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.