"Just-In-Time Training" in Pediatric Airway Management

NCT ID: NCT00631176

Last Updated: 2010-01-08

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a prospective interventional study 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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Orotracheal Intubation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Group Type EXPERIMENTAL

Just-In-Time Training

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Just-In-Time Training

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Over training Intubation training Rapid Refresher

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Pediatric or Emergency Medicine Residents rotating through PICU in CHOP.

Exclusion Criteria

1. Anesthesiology residents
2. Residents who had formal US training (ACGME accredited) in Neonatology or Pediatric Critical Care Medicine, Critical Care Medicine or Anesthesiology.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Children's Hospital of Philadelphia

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Vinay Nadkarni, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5U18HS016678-02

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

2006-8-4931

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Eliminating Monitor Overuse Trial (EMO Trial)
NCT05132322 ACTIVE_NOT_RECRUITING NA