Condition or disease | Intervention/treatment | Phase |
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Intubation;Difficult Intubation Complication | Procedure: stylet-assisted epiglottic lifting Device: bougie-assisted intubation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Traditional intubation technique direct and video laryngoscope, bougie-assisted intubation, intubation with stylet assisted epiglottis lifting |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Taipei City Hospital ZhongXing Branch, Emergency Department |
Estimated Study Start Date : | March 1, 2019 |
Estimated Primary Completion Date : | February 20, 2021 |
Estimated Study Completion Date : | February 20, 2021 |
Arm | Intervention/treatment |
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Active Comparator: bougie-assisted intubation
use bougie as guide, intubation with loading endotracheal tube under direct or video laryngoscopy
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Device: bougie-assisted intubation
use bougie as a introducer. Pass the bougie to the trachea and pass the tube via bougie guide.
Other Name: bougie introducer
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Active Comparator: intubation with epiglottic lifting
Lifting of epiglottis with stylet-equipped endotracheal tube to assist intubation under direct or video laryngoscopy
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Procedure: stylet-assisted epiglottic lifting
use stylet-equipped enodtracheal tube to lift the epiglottis and pass the endotracheal tube
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No Intervention: Traditional intubation
intubation under direct or video laryngoscopy without epiglottis lifting nor bougie-assited
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Taiwan | |
Taipei City Hospital Zhong-Xing branch | Recruiting |
Taipei, Taiwan, 100 | |
Contact: Tzu-Yao Hung, MD 886-2-979305599 bryansolitude@gmail.com |
Tracking Information | |||||
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First Submitted Date ICMJE | December 23, 2018 | ||||
First Posted Date ICMJE | January 18, 2019 | ||||
Last Update Posted Date | February 19, 2019 | ||||
Estimated Study Start Date ICMJE | March 1, 2019 | ||||
Estimated Primary Completion Date | February 20, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | TCHCCT-Zhong-Xing-Emergency-Department-airway-clincal (TTC) | ||||
Official Title ICMJE | Taipei City Hospital ZhongXing Branch, Emergency Department | ||||
Brief 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. 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 Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Traditional intubation technique direct and video laryngoscope, bougie-assisted intubation, intubation with stylet assisted epiglottis lifting Masking: Double (Participant, Investigator)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
200 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | February 20, 2021 | ||||
Estimated Primary Completion Date | February 20, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Taiwan | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03808896 | ||||
Other Study ID Numbers ICMJE | TCHCCT-ZXERRP | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Hung,Tzu-Yao, Taipei City Hospital | ||||
Study Sponsor ICMJE | Taipei City Hospital | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Taipei City Hospital | ||||
Verification Date | February 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |