Intubation;DifficultNCT03808896
TCHCCT-Zhong-Xing-Emergency-Department-airway-clincal (TTC)
A study testing stylet-assisted epiglottic lifting and bougie-assisted intubation in people with Intubation;Difficult and Intubation Complication, run by Taipei City Hospital at 1 site in Taiwan.
Trial summary
In the previous study on mannekin, the investigators found stylet-assisted lifting of epiglottis is an useful technique on difficult airway (Cormack-Lehane grade IIIa, IIIb) without increasing subjective difficulty. It has no expenses other than the routine intubation process. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation;Difficult, Intubation Complication
- What is being tested?
- stylet-assisted epiglottic lifting and bougie-assisted intubation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2019to 20 Feb 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all the patients present to the emergency department with airway emergency who need intubation
Who cannot join
- age below 18 year-old
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei City Hospital Zhong-Xing branch
Taipei, 100
Tzu-Yao Hung, MD, 886-2-979305599, bryansolitude@gmail.com
About this study
Official title: Taipei City Hospital ZhongXing Branch, Emergency Department
In the previous study on mannekin, the investigators found stylet-assisted lifting of epiglottis is an useful technique on difficult airway (Cormack-Lehane grade IIIa, IIIb) without increasing subjective difficulty. It has no expenses other than the routine intubation process. Recently, the studies have proved that the bougie-assisted laryngoscopy can improve first pass intubation rate in the emergency department. However, bougie is a disposable device and may increased medical expenditure. The investigators will evaluate the safety of bougie and epiglottic lifting technique, as well as the first pass and overall success rate of intubation comparing to traditional video laryngoscopy and direct laryngoscopy.
Read the detailed description
A better strategy of managing Cormack-Lehane Grade III had been investigated by our previous study. The investigators' research results had been accepted and published by the journal BioMeidcal Central Anesthesiology. The investigators will be eager to do the further clinical trial to investigate the impact of this technique clinically. Besides, bougie assisted intubation is a effective, evidenced-proved intervention. The investigators will also like to find out the prognosis differences between these two techniques.
- Conditions
- Intubation;Difficult, Intubation Complication
- Being tested
- stylet-assisted epiglottic lifting, bougie-assisted intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stylet-assisted epiglottic liftingProcedure or surgery
use stylet-equipped enodtracheal tube to lift the epiglottis and pass the endotracheal tube
bougie-assisted intubationDevice
Also called bougie introducer
use bougie as a introducer. Pass the bougie to the trachea and pass the tube via bougie guide.
| Study group | Role | What they receive |
|---|---|---|
| bougie-assisted intubation | Active comparator | use bougie as guide, intubation with loading endotracheal tube under direct or video laryngoscopy Receives: Device: bougie-assisted intubation |
| intubation with epiglottic lifting | Active comparator | Lifting of epiglottis with stylet-equipped endotracheal tube to assist intubation under direct or video laryngoscopy Receives: Procedure: stylet-assisted epiglottic lifting |
| Traditional intubation | No intervention | intubation under direct or video laryngoscopy without epiglottis lifting nor bougie-assited |
What is being measured
The primary outcome is the main question the study is designed to answer.
first pass success rate
first pass sucess rate
Measured: through the intubation period, an average of 90 seconds
duration of intubation
Measured: through the intubation period, an average of 90 seconds
Secondary outcomes (2)
Immediate complications direct related to intubation process
esophageal intubation, bleeding, tracheal perforation
Measured: through the intubation period, an average of 90 seconds
Overall success rate
Include all intubation event
Measured: within 48 hours of 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 2019
- Study start1 Mar 2019 (estimated)
- Primary completion20 Feb 2021 (estimated)
- Study completion20 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intubation;DifficultStudies 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
- Parallel groups
- Model description
- Traditional intubation technique direct and video laryngoscope, bougie-assisted intubation, intubation with stylet assisted epiglottis lifting
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hung,Tzu-Yao, Taipei City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808896
- Sponsor's protocol ID
- TCHCCT-ZXERRP
- Status last verified
- Feb 2019
- First submitted
- 23 Dec 2018
- Last updated
- 19 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Driver B, Dodd K, Klein LR, Buckley R, Robinson A, McGill JW, Reardon RF, Prekker ME. The Bougie and First-Pass Success in the Emergency Department. Ann Emerg Med. 2017 Oct;70(4):473-478.e1. doi: 10.1016/j.annemergmed.2017.04.033.
PubMed 28601269Ueda W, Arai YP. The Use of a Stylet to Aid the Lifting of the Epiglottis With a Video Laryngoscope. Anesth Pain Med. 2016 May 24;6(4):e38507. doi: 10.5812/aapm.38507. eCollection 2016 Aug.
PubMed 27843782
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taipei City Hospital ZhongXing Branch, Emergency Department
- ClinicalTrials.gov ID
- NCT03808896
- Acronym / sponsor ID
- TCHCCT-ZXERRP
- Conditions
- Intubation;Difficult, Intubation Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taipei City HospitalOther government
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 20 Feb 2021 (estimated)
- Study completion
- 20 Feb 2021 (estimated)
- First posted
- 18 Jan 2019 (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.
In the previous study on mannekin, the investigators found stylet-assisted lifting of epiglottis is an useful technique on difficult airway (Cormack-Lehane grade IIIa, IIIb) without increasing subjective difficulty. It has no expenses other than the routine intubation process. Recently, the studies have proved that the bougie-assisted laryngoscopy can improve first pass intubation rate in the emergency department. However, bougie is a disposable device and may increased medical expenditure. The investigators will evaluate the safety of bougie and epiglottic lifting technique, as well as the first pass and overall success rate of intubation comparing to traditional video laryngoscopy and direct laryngoscopy.
Detailed description
A better strategy of managing Cormack-Lehane Grade III had been investigated by our previous study. The investigators' research results had been accepted and published by the journal BioMeidcal Central Anesthesiology. The investigators will be eager to do the further clinical trial to investigate the impact of this technique clinically. Besides, bougie assisted intubation is a effective, evidenced-proved intervention. The investigators will also like to find out the prognosis differences between these two techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Traditional intubation technique direct and video laryngoscope, bougie-assisted intubation, intubation with stylet assisted epiglottis lifting
| Arm | Type | Receives |
|---|---|---|
| bougie-assisted intubation | Active comparator | Device: bougie-assisted intubationuse bougie as guide, intubation with loading endotracheal tube under direct or video laryngoscopy |
| intubation with epiglottic lifting | Active comparator | Procedure: stylet-assisted epiglottic liftingLifting of epiglottis with stylet-equipped endotracheal tube to assist intubation under direct or video laryngoscopy |
| Traditional intubation | No intervention | –intubation under direct or video laryngoscopy without epiglottis lifting nor bougie-assited |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all the patients present to the emergency department with airway emergency who need intubation
Key exclusion criteria (1 listed)
- age below 18 year-old
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 |
|---|---|---|
| stylet-assisted epiglottic liftinguse stylet-equipped enodtracheal tube to lift the epiglottis and pass the endotracheal tube | Procedure or surgery | intubation with epiglottic lifting |
| bougie-assisted intubationAlso: bougie introduceruse bougie as a introducer. Pass the bougie to the trachea and pass the tube via bougie guide. | Device | bougie-assisted intubation |
Primary outcome
first pass success rate
Time frame: through the intubation period, an average of 90 seconds
first pass sucess rate
duration of intubation
Time frame: through the intubation period, an average of 90 seconds
2 secondary outcomes
Immediate complications direct related to intubation process
Time frame: through the intubation period, an average of 90 seconds
Overall success rate
Time frame: within 48 hours of intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Background: PubMed 28601269Driver B, Dodd K, Klein LR, Buckley R, Robinson A, McGill JW, Reardon RF, Prekker ME. The Bougie and First-Pass Success in the Emergency Department. Ann Emerg Med. 2017 Oct;70(4):473-478.e1. doi: 10.1016/j.annemergmed.2017.04.033.
- Background: PubMed 27843782Ueda W, Arai YP. The Use of a Stylet to Aid the Lifting of the Epiglottis With a Video Laryngoscope. Anesth Pain Med. 2016 May 24;6(4):e38507. doi: 10.5812/aapm.38507. eCollection 2016 Aug.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stylet-assisted epiglottic lifting and bougie-assisted intubation in people with Intubation;Difficult and Intubation Complication, run by Taipei City Hospital at 1 site in Taiwan.
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: status not confirmed, as of the sponsor's last update on 19 Feb 2019. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
first pass success rate (time frame: through the intubation period, an average of 90 seconds). The study lists 2 primary outcomes in all. 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 NCT03808896, which also lists 2 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 19 Feb 2019.