Airway ManagementITBPNCT07747922
Novel Integrated Tube-Bougie Prototype for Endotracheal Intubation in Airway Simulation
A study testing EPATS (Integrated Tube-Bougie Prototype), Standard gum elastic bougie and Standard stylet in people with Airway Management and Endotracheal Intubation, run by Huseyin Cahit Halhalli, MD at 1 site in Turkey (Türkiye).
Trial summary
Endotracheal intubation is a critical airway management procedure that frequently requires adjunctive devices, such as stylets or elastic bougies, to facilitate successful tube placement. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Airway Management, Endotracheal Intubation, Difficult Airway
- What is being tested?
- EPATS (Integrated Tube-Bougie Prototype), Standard gum elastic bougie and Standard stylet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2026to 15 Dec 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Professional Status: Being an Emergency Medicine Resident actively undergoing specialty training at the University of Health Sciences, Kocaeli City Hospital, Department of Emergency Medicine.
- Voluntary Participation: Voluntarily agreeing to participate in the study and providing written informed consent prior to enrollment.
- Postgraduate year (PGY) 1-4 residents.
- Willing and able to provide written informed consent.
Who cannot join
- Refusal to Participate: Declining to participate or refusing to provide written informed consent.
- Physical or Neurological Limitations: Having any pre-existing physical, motor, or neurological impairment that could interfere with manual dexterity, procedural performance, or airway management simulation (e.g., hand injuries, tremors, etc.).
- Inability to complete all study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
University of Health Sciences, Kocaeli City Hospital
Köseköy, Kocaeli, 41060
Huseyin Cahit Halhalli, MD, +902622252700, huseyin.halhalli@sbu.edu.tr
About this study
Official title: A Prospective Randomized Crossover Simulation Study Comparing an Integrated Tube-Bougie Prototype With Standard Stilet-Assisted and Gum Elastic Bougie Assisted Endotracheal Intubation
Endotracheal intubation is a critical airway management procedure that frequently requires adjunctive devices, such as stylets or elastic bougies, to facilitate successful tube placement. Although videolaryngoscopy has become increasingly common, access to videolaryngoscopes remains limited in certain clinical settings, particularly in prehospital and resource-constrained environments. Consequently, stylets and bougies continue to play an essential role in airway management. To address this need, we developed a novel integrated tube-bougie prototype that combines the guidance function of an elastic bougie with an endotracheal tube into a single device.
This prospective, randomized, crossover simulation study is designed to compare the performance of the integrated tube-bougie prototype with conventional stylet-assisted and elastic bougie-assisted endotracheal intubation. Emergency medicine residents will perform intubations using all three techniques in both normal and difficult airway simulation scenarios according to a randomized crossover sequence.
Read more
The primary outcome is the time to successful endotracheal intubation. Secondary outcomes include first-attempt intubation success, perceived procedural difficulty assessed using a visual analog scale (VAS), incidence of esophageal intubation, dental trauma, and evaluation of the learning curve using cumulative sum (CUSUM) analysis.
The findings could contribute to the development of alternative airway assistive equipment for emergency airway management and training.
Read the detailed description
Endotracheal intubation is one of the most commonly performed advanced airway procedures in emergency and critical care. Successful intubation depends not only on adequate visualization of the glottis but also on successful advancement of the endotracheal tube through the vocal cords. Adjunctive devices, such as stylets and elastic bougies, are widely used to facilitate tube placement. However, these devices require additional procedural steps and device exchanges, which may increase procedural complexity and prolong intubation time.
EPATS (Integrated Tube-Bougie Prototype) is a novel airway device developed to integrate the guidance function of an elastic bougie directly into an endotracheal tube. By combining both functions into a single device, EPATS is intended to simplify the intubation process while preserving the advantages of bougie-assisted intubation.
This prospective, randomized, crossover simulation study will evaluate the performance of EPATS compared with conventional elastic bougie-assisted and stylet-assisted endotracheal intubation. Emergency medicine residents will perform endotracheal intubation using all three techniques in both normal and difficult airway simulation scenarios according to a randomized crossover sequence. Before study initiation, all participants will receive standardized training in the use of EPATS and the elastic bougie appropriate to their level of experience. All intubation procedures will be performed under standardized simulation conditions.
The primary outcome is the time to successful endotracheal intubation. Secondary outcomes include first-attempt intubation success, perceived procedural difficulty assessed using a visual analog scale (VAS), incidence of esophageal intubation, dental trauma, and evaluation of the learning curve using cumulative sum (CUSUM) analysis.
This study will determine whether EPATS improves procedural efficiency and intubation performance compared with conventional intubation adjuncts in a standardized simulation environment.
- Conditions
- Airway Management, Endotracheal Intubation, Difficult Airway
- Being tested
- EPATS (Integrated Tube-Bougie Prototype), Standard gum elastic bougie, Standard stylet
- Keywords
- Difficult Airway, Endotracheal Intubation, Airway Management, Emergency Medicine, Simulation, Manikin, Bougie, Gum Elastic Bougie, Stylet, EPATS, Medical Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPATS (Integrated Tube-Bougie Prototype)Device
The novel integrated tube-bougie prototype developed for endotracheal intubation.
Standard gum elastic bougieDevice
Standard gum elastic bougie used as an intubation adjunct.
Standard styletDevice
Standard intubating stylet used as an intubation adjunct.
| Study group | Role | What they receive |
|---|---|---|
| EPATS | Experimental | Participants will perform endotracheal intubation using the EPATS (Integrated Tube-Bougie Prototype) in both normal and difficult airway simulation scenarios. Receives: Device: EPATS (Integrated Tube-Bougie Prototype) |
| Standard Gum Elastic Bougie | Active comparator | Participants will perform endotracheal intubation using a standard gum elastic bougie in both normal and difficult airway simulation scenarios. Receives: Device: Standard gum elastic bougie |
| Standard Stylet | Active comparator | Participants will perform endotracheal intubation using a standard stylet in both normal and difficult airway simulation scenarios. Receives: Device: Standard stylet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to successful endotracheal intubation
The insertion and removal time (seconds) of the laryngoscope from the mouth will be recorded.
Measured: During the study procedure
Secondary outcomes (4)
First Pass Success (FPS)
Successful endotracheal intubation without removing the laryngoscope from the mouth. Attempts exceeding 60 seconds will be considered unsuccessful.
Measured: During the study procedure
Difficulty Assessment (VAS)
The practitioner's difficulty perception will be measured using a 0-100 mm visual analog scale.
Measured: At the end of the study procedure
Complications (Dental trauma and Esophageal intubation)
Complications for each procedure (dental trauma and esophageal intubation) will be determined by the researchers.
Measured: During the study procedure
Learning Curve (CUSUM)
For each participant, success/failure data will be used for analysis; this analysis will be considered exploratory. The number of endotracheal intubation attempts required to learn will be recorded in the data collection. Sequential intubation performance data will be analyzed using cumulative sum (CUSUM) analysis.
Measured: During the study procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start15 Oct 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will perform endotracheal intubation using three different techniques (EPATS, standard gum elastic bougie, and standard stylet) in each of the normal and difficult airway simulation scenarios. The order of interventions will be randomized, and each participant will complete all interventions according to a random crossover sequence.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huseyin Cahit Halhalli, MD
- Sponsor type
- Other government
- Collaborators
- Health Institutes of Turkey
- Responsible party
- Sponsor-investigator, Huseyin Cahit Halhalli, MD, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747922
- Sponsor's protocol ID
- ITBP-2026-01
- Acronym
- ITBP
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data (IPD) that comprise the published results will be shared. The shared data will include participant characteristics, randomization order, intubation performance measures (time to successful intubation, success on first attempt, difficulty rating, complications), and variables comprising primary and secondary analyses. No personal information will be included.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Crossover Simulation Study Comparing an Integrated Tube-Bougie Prototype With Standard Stilet-Assisted and Gum Elastic Bougie Assisted Endotracheal Intubation
- ClinicalTrials.gov ID
- NCT07747922
- Acronym / sponsor ID
- ITBP / ITBP-2026-01
- Conditions
- Airway Management, Endotracheal Intubation, Difficult Airway
- Keywords
- Difficult Airway, Endotracheal Intubation, Airway Management, Emergency Medicine, Simulation, Manikin, Bougie, Gum Elastic Bougie
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Huseyin Cahit Halhalli, MDOther government
- Collaborators
- Health Institutes of Turkey
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 5 Aug 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.
Endotracheal intubation is a critical airway management procedure that frequently requires adjunctive devices, such as stylets or elastic bougies, to facilitate successful tube placement. Although videolaryngoscopy has become increasingly common, access to videolaryngoscopes remains limited in certain clinical settings, particularly in prehospital and resource-constrained environments. Consequently, stylets and bougies continue to play an essential role in airway management. To address this need, we developed a novel integrated tube-bougie prototype that combines the guidance function of an elastic bougie with an endotracheal tube into a single device.
This prospective, randomized, crossover simulation study is designed to compare the performance of the integrated tube-bougie prototype with conventional stylet-assisted and elastic bougie-assisted endotracheal intubation. Emergency medicine residents will perform intubations using all three techniques in both normal and difficult airway simulation scenarios according to a randomized crossover sequence.
The primary outcome is the time to successful endotracheal intubation. Secondary outcomes include first-attempt intubation success, perceived procedural difficulty assessed using a visual analog scale (VAS), incidence of esophageal intubation, dental trauma, and evaluation of the learning curve using cumulative sum (CUSUM) analysis.
The findings could contribute to the development of alternative airway assistive equipment for emergency airway management and training.
Detailed description
Endotracheal intubation is one of the most commonly performed advanced airway procedures in emergency and critical care. Successful intubation depends not only on adequate visualization of the glottis but also on successful advancement of the endotracheal tube through the vocal cords. Adjunctive devices, such as stylets and elastic bougies, are widely used to facilitate tube placement. However, these devices require additional procedural steps and device exchanges, which may increase procedural complexity and prolong intubation time.
EPATS (Integrated Tube-Bougie Prototype) is a novel airway device developed to integrate the guidance function of an elastic bougie directly into an endotracheal tube. By combining both functions into a single device, EPATS is intended to simplify the intubation process while preserving the advantages of bougie-assisted intubation.
This prospective, randomized, crossover simulation study will evaluate the performance of EPATS compared with conventional elastic bougie-assisted and stylet-assisted endotracheal intubation. Emergency medicine residents will perform endotracheal intubation using all three techniques in both normal and difficult airway simulation scenarios according to a randomized crossover sequence. Before study initiation, all participants will receive standardized training in the use of EPATS and the elastic bougie appropriate to their level of experience. All intubation procedures will be performed under standardized simulation conditions.
The primary outcome is the time to successful endotracheal intubation. Secondary outcomes include first-attempt intubation success, perceived procedural difficulty assessed using a visual analog scale (VAS), incidence of esophageal intubation, dental trauma, and evaluation of the learning curve using cumulative sum (CUSUM) analysis.
This study will determine whether EPATS improves procedural efficiency and intubation performance compared with conventional intubation adjuncts in a standardized simulation environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will perform endotracheal intubation using three different techniques (EPATS, standard gum elastic bougie, and standard stylet) in each of the normal and difficult airway simulation scenarios. The order of interventions will be randomized, and each participant will complete all interventions according to a random crossover sequence.
| Arm | Type | Receives |
|---|---|---|
| EPATS | Experimental | Device: EPATS (Integrated Tube-Bougie Prototype)Participants will perform endotracheal intubation using the EPATS (Integrated Tube-Bougie Prototype) in both normal and difficult airway simulation scenarios. |
| Standard Gum Elastic Bougie | Active comparator | Device: Standard gum elastic bougieParticipants will perform endotracheal intubation using a standard gum elastic bougie in both normal and difficult airway simulation scenarios. |
| Standard Stylet | Active comparator | Device: Standard styletParticipants will perform endotracheal intubation using a standard stylet in both normal and difficult airway simulation scenarios. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Professional Status: Being an Emergency Medicine Resident actively undergoing specialty training at the University of Health Sciences, Kocaeli City Hospital, Department of Emergency Medicine.
- Voluntary Participation: Voluntarily agreeing to participate in the study and providing written informed consent prior to enrollment.
- Postgraduate year (PGY) 1-4 residents.
- Willing and able to provide written informed consent.
Key exclusion criteria (3 listed)
- Refusal to Participate: Declining to participate or refusing to provide written informed consent.
- Physical or Neurological Limitations: Having any pre-existing physical, motor, or neurological impairment that could interfere with manual dexterity, procedural performance, or airway management simulation (e.g., hand injuries, tremors, etc.).
- Inability to complete all study procedures.
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 |
|---|---|---|
| EPATS (Integrated Tube-Bougie Prototype)The novel integrated tube-bougie prototype developed for endotracheal intubation. | Device | EPATS |
| Standard gum elastic bougieStandard gum elastic bougie used as an intubation adjunct. | Device | Standard Gum Elastic Bougie |
| Standard styletStandard intubating stylet used as an intubation adjunct. | Device | Standard Stylet |
Primary outcome
Time to successful endotracheal intubation
Time frame: During the study procedure
The insertion and removal time (seconds) of the laryngoscope from the mouth will be recorded.
4 secondary outcomes
First Pass Success (FPS)
Time frame: During the study procedure
Difficulty Assessment (VAS)
Time frame: At the end of the study procedure
Complications (Dental trauma and Esophageal intubation)
Time frame: During the study procedure
Learning Curve (CUSUM)
Time frame: During the study procedure
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 2 Sep 2026.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data (IPD) that comprise the published results will be shared. The shared data will include participant characteristics, randomization order, intubation performance measures (time to successful intubation, success on first attempt, difficulty rating, complications), and variables comprising primary and secondary analyses. No personal information will be included.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPATS (Integrated Tube-Bougie Prototype), Standard gum elastic bougie and Standard stylet in people with Airway Management and Endotracheal Intubation, run by Huseyin Cahit Halhalli, MD at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 2 Sep 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 Turkey (Türkiye). 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?
Contact Huseyin Cahit Halhalli, MD (+902622252700, huseyin.halhalli@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to successful endotracheal intubation (time frame: During the study procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2026.