Endotracheal IntubationNCT05689125
Bougies as Aid for Endotracheal Intubation Via Video Laryngoscopy During Continuous Chest Compressions
A study testing Railroaded bougie, Preloaded bougie and Stylet in people with Endotracheal Intubation and Cardiopulmonary Resuscitation, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The goal of this clinical trials is to analyze the effects of using bougies as adjuncts on the performance of endotracheal intubation via video laryngoscopy during cardiopulmonary resuscitation in anesthesia residents. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endotracheal Intubation, Cardiopulmonary Resuscitation, Simulation
- What is being tested?
- Railroaded bougie, Preloaded bougie and Stylet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 9 Feb 2023to 20 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Residents who are enrolled in the three-year standardized residency training program in the Department of Anesthesiology, Peking Union Medical College Hospital in February, 2023.
Who cannot join
- Residents who refuse to participate and residents who fail the pre-test.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Bougies as Aid for Endotracheal Intubation Via Video Laryngoscopy During Continuous Chest Compressions by Anesthesia Residents: a Randomized Crossover Simulation Trial
The goal of this clinical trials is to analyze the effects of using bougies as adjuncts on the performance of endotracheal intubation via video laryngoscopy during cardiopulmonary resuscitation in anesthesia residents. The main question it aims to answer is whether bougie use has a significant effect on first-attempt failure of endotracheal intubation via video laryngoscopy during continuous chest compressions. Participants will perform endotracheal intubation via video laryngoscopy by four methods in a randomized order in a simulated cardiopulmonary resuscitation scenario on a manikin. The four methods are endotracheal intubations assisted by a railroaded bougie, assisted by a preloaded bougie, assisted by a stylet, and with no assistance. Researchers will compare the first-attempt failure rate of the four methods to see if a railroaded bougie method has a significant different first-attempt failure from that of the other three methods.
- Being tested
- Railroaded bougie, Preloaded bougie, Stylet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Railroaded bougieDevice
Residents expose the glottis by a video laryngoscope and place the tip of bougie through the vocal cords. Then, an assistant loads an endotracheal tube on the free end of the bougie. Residents advance the endotracheal tube over the bougie and withdraw the bougie.
Preloaded bougieDevice
Residents expose the glottis by a video laryngoscope and perform the endotracheal intubation using a bougie with a preloaded endotracheal tube while an assistant secures the free end of the bougie. Residents withdraw the bougie when the endotracheal tube reaches an appropriate depth.
StyletDevice
Residents expose the glottis by a video laryngoscope and perform the endotracheal intubation with the assistance of a stylet. An assistant withdraws the stylet when the tip of the endotracheal tube passes through the vocal cords. Then residents place the endotracheal tube to an appropriate depth.
| Study group | Role | What they receive |
|---|---|---|
| Railroaded bougie | Experimental | An endotracheal tube is loaded onto a bougie posterior to the placement of the bougie into the trachea. Receives: Device: Railroaded bougie |
| Preloaded bougie | Other | An endotracheal tube is loaded onto a bougie prior to initiating laryngoscopy. Receives: Device: Preloaded bougie |
| Stylet | Active comparator | A stylet is placed within an endotracheal tube prior to initiating laryngoscopy. Receives: Device: Stylet |
| Naked endotracheal tube | No intervention | Residents expose the glottis by a video laryngoscope and perform the endotracheal intubation without assistance of stylet or bougie. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure on the first attempt
An attempt is terminated and defined as a failure when a resident tries for one minute but is still unable to start ventilation, or when a resident feels unable to succeed and decides to give up, or when a resident withdraws a laryngoscope blade, a bougie, or a tube out of the month after the initial insertion. This outcome will be measured based on videos of endotracheal intubation procedures recorded by a camera placed on the right side of the manikin.
Measured: At the completion of the intubation
Secondary outcomes (4)
Failure on two attempts
If the first attempt of a method fails, the resident will be given a second opportunity of the same method. This outcome will be measured based on videos of endotracheal intubation procedures recorded by a camera placed on the right side of the manikin.
Measured: At the completion of the intubation
Duration of the first attempt
The time elapsed between the insertion of a laryngoscope blade into the month and either the start of ventilation in a successful attempt or the termination of a failed attempt. This outcome will be measured based on videos of endotracheal intubation procedures recorded by a camera placed on the right side of the manikin.
Measured: At the completion of the intubation
Overall intubation duration
Duration of the first attempt if it succeeds or the sum of the duration of both attempts if the first attempt fails. This outcome will be measured based on videos of endotracheal intubation procedures recorded by a camera placed on the right side of the manikin.
Measured: At the completion of the intubation
Self-reported intubation difficulty
0-10 ranking scale with 0 representing "the easiest" and 10 "the most difficult" rated by the residents.
Measured: At the completion of the intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start9 Feb 2023
- Primary completion20 Feb 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will perform endotracheal intubation by four methods in a randomized order. The four methods are endotracheal intubations assisted by a railroaded bougie, assisted by a preloaded bougie, assisted by a stylet, and with no assistance.
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang YuGuang, Peking Union Medical College Hospital
- Investigators
- Xu Li, MD, Study chair, Peking Union Medical College HospitalYuguang Huang, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689125
- Sponsor's protocol ID
- K2562
- Status last verified
- Jun 2023
- First submitted
- 6 Jan 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study plan can be obtained from the principal investigator on request.
Publications
Xu X, Ma H, Zhang Y, Liu W, Jung B, Li X, Shen L. Efficacy of bougie first approach for endotracheal intubation with video laryngoscopy during continuous chest compression: a randomized crossover manikin trial. BMC Anesthesiol. 2024 May 21;24(1):181. doi: 10.1186/s12871-024-02560-3.
PubMed 38773386
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bougies as Aid for Endotracheal Intubation Via Video Laryngoscopy During Continuous Chest Compressions by Anesthesia Residents: a Randomized Crossover Simulation Trial
- ClinicalTrials.gov ID
- NCT05689125
- Acronym / sponsor ID
- K2562
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 18 Jan 2023 (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.
The goal of this clinical trials is to analyze the effects of using bougies as adjuncts on the performance of endotracheal intubation via video laryngoscopy during cardiopulmonary resuscitation in anesthesia residents. The main question it aims to answer is whether bougie use has a significant effect on first-attempt failure of endotracheal intubation via video laryngoscopy during continuous chest compressions. Participants will perform endotracheal intubation via video laryngoscopy by four methods in a randomized order in a simulated cardiopulmonary resuscitation scenario on a manikin. The four methods are endotracheal intubations assisted by a railroaded bougie, assisted by a preloaded bougie, assisted by a stylet, and with no assistance. Researchers will compare the first-attempt failure rate of the four methods to see if a railroaded bougie method has a significant different first-attempt failure from that of the other three methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will perform endotracheal intubation by four methods in a randomized order. The four methods are endotracheal intubations assisted by a railroaded bougie, assisted by a preloaded bougie, assisted by a stylet, and with no assistance.
| Arm | Type | Receives |
|---|---|---|
| Railroaded bougie | Experimental | Device: Railroaded bougieAn endotracheal tube is loaded onto a bougie posterior to the placement of the bougie into the trachea. |
| Preloaded bougie | Other | Device: Preloaded bougieAn endotracheal tube is loaded onto a bougie prior to initiating laryngoscopy. |
| Stylet | Active comparator | Device: StyletA stylet is placed within an endotracheal tube prior to initiating laryngoscopy. |
| Naked endotracheal tube | No intervention | –Residents expose the glottis by a video laryngoscope and perform the endotracheal intubation without assistance of stylet or bougie. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Residents who are enrolled in the three-year standardized residency training program in the Department of Anesthesiology, Peking Union Medical College Hospital in February, 2023.
Key exclusion criteria (1 listed)
- Residents who refuse to participate and residents who fail the pre-test.
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 |
|---|---|---|
| Railroaded bougieResidents expose the glottis by a video laryngoscope and place the tip of bougie through the vocal cords. Then, an assistant loads an endotracheal tube on the free end of the bougie. Residents advance the endotracheal tube over the bougie and withdraw the bougie. | Device | Railroaded bougie |
| Preloaded bougieResidents expose the glottis by a video laryngoscope and perform the endotracheal intubation using a bougie with a preloaded endotracheal tube while an assistant secures the free end of the bougie. Residents withdraw the bougie when the endotracheal tube reaches an appropriate depth. | Device | Preloaded bougie |
| StyletResidents expose the glottis by a video laryngoscope and perform the endotracheal intubation with the assistance of a stylet. An assistant withdraws the stylet when the tip of the endotracheal tube passes through the vocal cords. Then residents place the endotracheal tube to an appropriate depth. | Device | Stylet |
Primary outcome
Failure on the first attempt
Time frame: At the completion of the intubation
An attempt is terminated and defined as a failure when a resident tries for one minute but is still unable to start ventilation, or when a resident feels unable to succeed and decides to give up, or when a resident withdraws a laryngoscope blade, a bougie, or a tube out of the month after the initial insertion. This outcome will be measured based on videos of endotracheal intubation procedures recorded by a camera placed on the right side of the manikin.
4 secondary outcomes
Failure on two attempts
Time frame: At the completion of the intubation
Duration of the first attempt
Time frame: At the completion of the intubation
Overall intubation duration
Time frame: At the completion of the intubation
Self-reported intubation difficulty
Time frame: At the completion of the intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Derived from this study: PubMed 38773386Xu X, Ma H, Zhang Y, Liu W, Jung B, Li X, Shen L. Efficacy of bougie first approach for endotracheal intubation with video laryngoscopy during continuous chest compression: a randomized crossover manikin trial. BMC Anesthesiol. 2024 May 21;24(1):181. doi: 10.1186/s12871-024-02560-3.
- Individual participant dataSharing planned: No. The study plan can be obtained from the principal investigator on request.
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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. This study is not recruiting at the moment.
Xu Li, MD study chair
Peking Union Medical College Hospital
Yuguang Huang, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Railroaded bougie, Preloaded bougie and Stylet in people with Endotracheal Intubation and Cardiopulmonary Resuscitation, run by Peking Union Medical College Hospital at 1 site in China.
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 1 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: finished, as of the sponsor's last update on 13 Jun 2023. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Failure on the first attempt (time frame: At the completion of the intubation). 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 NCT05689125, which also lists 1 linked publication.
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 13 Jun 2023.