Difficult Airway IntubationNCT07915661
Pediatric Intubation Simulations With Bougie
A study testing Simulation-Based Bougie-Assisted Pediatric Intubation Training in people with Difficult Airway Intubation, run by University of Texas at Austin at 1 site in United States.
Trial summary
This study evaluates whether simulation-based training improves pediatric emergency medicine providers' competence and confidence in bougie-assisted intubation for difficult pediatric airways. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Difficult Airway Intubation
- What is being tested?
- Simulation-Based Bougie-Assisted Pediatric Intubation Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pediatric Emergency Medicine, Pediatric Intensive Care Unit, and Anesthesiology providers at our institution
Who cannot join
- Providers not in the above specialties or not currently seeing patients at our institution.
- Providers who are also simulation staff
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas at Austin
Austin, Texas, 78723
About this study
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.
Read the detailed description
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:
- To assess baseline experience, comfort, confidence, and utilization of bougie-assisted intubation
- To evaluate the effect of simulation-based bougie training on provider confidence and competence in performing bougie-assisted pediatric intubation
- To assess retention of provider confidence at 6 months following simulation-based training
- Conditions
- Difficult Airway Intubation
- Being tested
- Simulation-Based Bougie-Assisted Pediatric Intubation Training
- Keywords
- simulation, pediatrics, intubation, emergency medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation-Based Bougie-Assisted Pediatric Intubation TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Post-Tonsillectomy Bleeding to Cervical Spine Injury | Experimental | Participants receive bougie education and practice before completing a difficult airway simulation involving post-tonsillectomy bleeding, followed by a simulation involving cervical spine injury. Receives: Other: Simulation-Based Bougie-Assisted Pediatric Intubation Training |
| Cervical Spine Injury to Post-Tonsillectomy Bleeding | Experimental | 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. Receives: Other: Simulation-Based Bougie-Assisted Pediatric Intubation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the simulation session (approximately 30 minutes).
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Six months following simulation-based training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start27 Oct 2026
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Difficult Airway IntubationStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lina Palomares, University of Texas at Austin
- Investigators
- Matthew Wilkinson, MD, MPH, Study director, The University of Texas at Austin Dell Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915661
- Sponsor's protocol ID
- 00009870
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Prekker ME, Bjorklund AR, Myers C, Harvey L, Horton GB, Goldstein J, Usher SC, Reardon RF, Robinson A, Strobel AM, Driver BE. The Pediatric Bougie for the First Tracheal Intubation Attempt in Critically Ill Children. Ann Emerg Med. 2023 Jun;81(6):667-676. doi: 10.1016/j.annemergmed.2023.01.016. Epub 2023 Feb 24.
PubMed 36841658Nishisaki A, Turner DA, Brown CA 3rd, Walls RM, Nadkarni VM; National Emergency Airway Registry for Children (NEAR4KIDS); Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. A National Emergency Airway Registry for children: landscape of tracheal intubation in 15 PICUs. Crit Care Med. 2013 Mar;41(3):874-85. doi: 10.1097/CCM.0b013e3182746736.
PubMed 23328260Shen HN, Lu CL, Li CY. Do physicians have lower risk of severe sepsis and associated mortality? A matched cohort study*. Crit Care Med. 2014 Apr;42(4):816-23. doi: 10.1097/CCM.0000000000000033.
PubMed 24231761Elendu C, Amaechi DC, Okatta AU, Amaechi EC, Elendu TC, Ezeh CP, Elendu ID. The impact of simulation-based training in medical education: A review. Medicine (Baltimore). 2024 Jul 5;103(27):e38813. doi: 10.1097/MD.0000000000038813.
PubMed 38968472
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Intubation Simulations With Bougie
- ClinicalTrials.gov ID
- NCT07915661
- Acronym / sponsor ID
- 00009870
- Conditions
- Difficult Airway Intubation
- Keywords
- simulation, pediatrics, intubation, emergency medicine
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 27 Oct 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Nov 2026 (actual)
- 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.
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.
Detailed description
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:
- To assess baseline experience, comfort, confidence, and utilization of bougie-assisted intubation
- To evaluate the effect of simulation-based bougie training on provider confidence and competence in performing bougie-assisted pediatric intubation
- To assess retention of provider confidence at 6 months following simulation-based training
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-Tonsillectomy Bleeding to Cervical Spine Injury | Experimental | Other: Simulation-Based Bougie-Assisted Pediatric Intubation TrainingParticipants receive bougie education and practice before completing a difficult airway simulation involving post-tonsillectomy bleeding, followed by a simulation involving cervical spine injury. |
| Cervical Spine Injury to Post-Tonsillectomy Bleeding | Experimental | Other: Simulation-Based Bougie-Assisted Pediatric Intubation TrainingParticipants 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pediatric Emergency Medicine, Pediatric Intensive Care Unit, and Anesthesiology providers at our institution
Key exclusion criteria (2 listed)
- Providers not in the above specialties or not currently seeing patients at our institution.
- Providers who are also simulation staff
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 |
|---|---|---|
| Simulation-Based Bougie-Assisted Pediatric Intubation TrainingParticipants 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. | Other | Cervical Spine Injury to Post-Tonsillectomy Bleeding, Post-Tonsillectomy Bleeding to Cervical Spine Injury |
Primary outcome
Time to Successful Bougie-Assisted Intubation
Time frame: During the simulation session (approximately 30 minutes).
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.
3 secondary outcomes
Change in Provider Comfort and Confidence With Bougie-Assisted Intubation
Time frame: Immediately before and after simulation-based training (approximately 60 minutes).
Retention of Provider Comfort and Confidence at 6 Months
Time frame: Baseline, immediately post-simulation, and 6 months post-simulation.
Frequency of Clinical Bougie Use Following Simulation-Based Training
Time frame: Six months following simulation-based training.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 36841658Prekker ME, Bjorklund AR, Myers C, Harvey L, Horton GB, Goldstein J, Usher SC, Reardon RF, Robinson A, Strobel AM, Driver BE. The Pediatric Bougie for the First Tracheal Intubation Attempt in Critically Ill Children. Ann Emerg Med. 2023 Jun;81(6):667-676. doi: 10.1016/j.annemergmed.2023.01.016. Epub 2023 Feb 24.
- Background: PubMed 23328260Nishisaki A, Turner DA, Brown CA 3rd, Walls RM, Nadkarni VM; National Emergency Airway Registry for Children (NEAR4KIDS); Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. A National Emergency Airway Registry for children: landscape of tracheal intubation in 15 PICUs. Crit Care Med. 2013 Mar;41(3):874-85. doi: 10.1097/CCM.0b013e3182746736.
- Background: PubMed 24231761Shen HN, Lu CL, Li CY. Do physicians have lower risk of severe sepsis and associated mortality? A matched cohort study*. Crit Care Med. 2014 Apr;42(4):816-23. doi: 10.1097/CCM.0000000000000033.
- Background: PubMed 38968472Elendu C, Amaechi DC, Okatta AU, Amaechi EC, Elendu TC, Ezeh CP, Elendu ID. The impact of simulation-based training in medical education: A review. Medicine (Baltimore). 2024 Jul 5;103(27):e38813. doi: 10.1097/MD.0000000000038813.
- Individual participant dataSharing planned: 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.
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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.
Matthew Wilkinson, MD, MPH study director
The University of Texas at Austin Dell Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation-Based Bougie-Assisted Pediatric Intubation Training in people with Difficult Airway Intubation, run by University of Texas at Austin 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 1 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 4 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Time to Successful Bougie-Assisted Intubation (time frame: During the simulation session (approximately 30 minutes).). 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 NCT07915661, which also lists 4 linked publications.
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 4 Nov 2026.