- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00631176
"Just-In-Time Training" in Pediatric Airway Management (JIT)
Effectiveness of "Just-In-Time" Training With/Without a High Fidelity Simulation on Patient Safety in Airway Management in Pediatric Intensive Care Unit
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
Appropriate airway management is the most critical point in pediatric resuscitation and pediatric critical care. It remains, however, a challenge for pediatric residents to learn and retain this critical skill. Recent report from our PICU showed pediatric residents participated only 28% of initial orotracheal intubation, and the rate of the first successful endotracheal tube placement was only 38% of all orotracheal intubation attempt. Repetitive poor-skilled intubation attempts may be associated with complication such as dental or laryngeal contusion, and prolonged intubation attempt may be associated with hypoxia and hemodynamic instability. In order to improve the operational performance in the efficacy (first attempt success rate) and safety (minimizing the associated events which could potentially lead to adverse events), a better training method is warranted.
Objectives:
To test the hypothesis that just-in-time training for pediatric airway management may improve patient safety and operational performance of orotracheal intubation and decreases intubation associated events in pediatric residents in the PICU. To test the hypothesis that high fidelity simulation may enhance the training efficacy and patient safety in simulation settings.
Study Design:
This is a prospective interventional study. During the eighteen months of study period, one of two on-call pediatric residents from 7 south PICU (24 beds) will receive 20 minutes of just-in-time pediatric airway management training. This training will occur before their shift starts before the morning round. This training will cover direct laryngoscopy technique, orotracheal intubation technique, confirmation of the tube placement and recognition of associated events. This training will be done with or without high fidelity simulation function. We will use SimBaby (Laerdal, Norway). The assignment will be randomized. The clinical data of orotracheal intubation are collected through NEAR-4 KIDS registry. Primary outcome is a change in a first attempt success rate by the residents in an overtrained group (7 South PICU) compared to standard training group (7 East PICU). The secondary outcome is the rate of resident participation in orotracheal intubation attempt, the number of intubation attempt before successful intubation by residents and the number of intubation associated events. The videotaped performance during the training is analyzed with Healthcare Failure Mode and Effect Analysis (HFMEA) and will be compared between high fidelity simulation training group and low fidelity simulation training group. The evaluation system developed by HFMEA will be validated by a performance of experienced and non-experienced intubators. Furthermore, the real orotracheal intubation team performance in both PICUs will be evaluated with scale by a research assistant. The demographic and training data of participants of real PICU intubations will be collected. No patient identifiable information will be collected. This data will also be kept in a password-protected research computer.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pediatric or Emergency Medicine Residents rotating through PICU in CHOP.
Exclusion Criteria:
- Anesthesiology residents
- Residents who had formal US training (ACGME accredited) in Neonatology or Pediatric Critical Care Medicine, Critical Care Medicine or Anesthesiology.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 2
|
On-call pediatric residents from 7 south PICU (24 beds) will receive 20 minutes of just-in-time pediatric airway management training.
This training will occur before their shift starts before the morning round.
This training will cover direct laryngoscopy technique, orotracheal intubation technique, confirmation of the tube placement and recognition of associated events.
This training will be done with or without high fidelity simulation function.
Other Names:
|
|
No Intervention: 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The primary endpoint will be the success of first intubation attempts by a resident.
Time Frame: per case
|
per case
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Vinay Nadkarni, MD, Children's Hospital of Philadelphia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2006-8-4931
- 5U18HS016678-02 (U.S. AHRQ Grant/Contract)
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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