An interventional study of Simulation-Based Bougie-Assisted Pediatric Intubation Training in Difficult Airway Intubation, sponsored by University of Texas at Austin. Enrolling by invitation at 1 site in United States. Open to participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by University of Texas at Austin · Not applicable, Interventional, and Other
This study evaluates whether simulation-based training improves pediatric emergency medicine providers' competence and confidence in bougie-assisted intubation for difficult pediatric airways. Because pediatric intubation is a high-risk, low-frequency procedure, simulation provides a safe environment for developing and assessing airway management skills. The study will assess providers' baseline experience and confidence, evaluate improvements following training, and examine confidence retention at six months.
Difficulty in pediatric airway management is associated with significant morbidity and mortality, including cardiac arrest and neurologic injury. Proficiency with airway management tools is essential for pediatric emergency medicine providers. The bougie, a flexible introducer used to facilitate endotracheal intubation, is widely used in adult airway management but has been less studied in pediatric populations.
Due to ethical and practical limitations, there is limited opportunity to study airway interventions in pediatric patients using randomized designs. Simulation-based training provides a safe and effective method to teach and evaluate skills for high-acuity, low-frequency procedures such as pediatric intubation.
The purpose of this study is to evaluate the use of simulation-based training for bougie-assisted intubation in pediatric emergency providers. The primary study research question is: Does simulation-based bougie training improve provider competence and confidence in managing difficult pediatric airways?
Study objectives include:
University of Texas at Austin is the lead sponsor of 328 studies on the registry; 79 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
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Exclusion Criteria:
Participants receive bougie education and practice before completing a difficult airway simulation involving post-tonsillectomy bleeding, followed by a simulation involving cervical spine injury.
Other: Simulation-Based Bougie-Assisted Pediatric Intubation Training
Participants will complete a simulation involving a difficult airway in a trauma patient with a cervical spine injury, followed by a simulation involving post-tonsillectomy bleeding. Bougie-assisted intubation performance will be assessed during both scenarios.
Other: Simulation-Based Bougie-Assisted Pediatric Intubation Training
Participants will receive a 5-minute educational lecture on bougie-assisted intubation, followed by 10 minutes of hands-on practice using a pediatric airway manikin. Participants will then complete two simulated difficult pediatric airway scenarios: (1) post-tonsillectomy bleeding with a bloody airway and (2) trauma with cervical spine immobilization. Using a randomized crossover design, participants will be assigned to the order in which they complete the scenarios. Each scenario will involve bougie-assisted intubation using a pediatric manikin and will be video-recorded to assess time to successful intubation. Participants will complete pre- and post-simulation surveys assessing confidence and comfort with bougie use, as well as a 6-month follow-up survey assessing confidence and self-reported clinical use.
Time to Successful Bougie-Assisted Intubation
Time (in seconds) from insertion of the laryngoscope into the mouth until successful endotracheal intubation and removal of the laryngoscope. Time will be measured for each of two simulated difficult pediatric airway scenarios using video recordings. Intubation times will be compared between scenarios and randomized sequences.
Time frame: During the simulation session (approximately 30 minutes).
Change in Provider Comfort and Confidence With Bougie-Assisted Intubation
Change in self-reported comfort and confidence with bougie-assisted pediatric intubation from pre-simulation to immediately post-simulation, as measured by participant surveys. Responses will be compared to assess changes following simulation-based training.
Time frame: Immediately before and after simulation-based training (approximately 60 minutes).
Retention of Provider Comfort and Confidence at 6 Months
Change in self-reported comfort with bougie-assisted pediatric intubation from baseline to immediately following simulation-based training. Comfort will be measured using a 5-point Likert scale, with higher scores indicating greater comfort. Changes in comfort scores will be assessed by comparing pre-simulation and post-simulation survey responses.
Time frame: Baseline, immediately post-simulation, and 6 months post-simulation.
Frequency of Clinical Bougie Use Following Simulation-Based Training
Participants will report the number of times they have used a bougie during clinical intubation procedures in the 6 months following simulation-based training. The outcome will be measured as the self-reported number of bougie-assisted intubations per participant during the follow-up period.
Time frame: Six months following simulation-based training.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual participant data (IPD) will not be shared due to the small sample size and potential risk of participant identification. The study involves healthcare providers from a single institution, and sharing individual-level data could compromise participant confidentiality.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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