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出境医 / 临床实验 / TCHCCT-Zhong-Xing-Emergency-Department-airway-clincal (TTC)

TCHCCT-Zhong-Xing-Emergency-Department-airway-clincal (TTC)

Study Description
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.

Condition or disease Intervention/treatment Phase
Intubation;Difficult Intubation Complication Procedure: stylet-assisted epiglottic lifting Device: bougie-assisted intubation Not Applicable

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
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
Active Comparator: bougie-assisted intubation
use bougie as guide, intubation with loading endotracheal tube under direct or video laryngoscopy
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

Active Comparator: intubation with epiglottic lifting
Lifting of epiglottis with stylet-equipped endotracheal tube to assist intubation under direct or video laryngoscopy
Procedure: stylet-assisted epiglottic lifting
use stylet-equipped enodtracheal tube to lift the epiglottis and pass the endotracheal tube

No Intervention: Traditional intubation
intubation under direct or video laryngoscopy without epiglottis lifting nor bougie-assited
Outcome Measures
Primary Outcome Measures :
  1. first pass success rate [ Time Frame: through the intubation period, an average of 90 seconds ]
    first pass sucess rate

  2. duration of intubation [ Time Frame: through the intubation period, an average of 90 seconds ]

Secondary Outcome Measures :
  1. Immediate complications direct related to intubation process [ Time Frame: through the intubation period, an average of 90 seconds ]
    esophageal intubation, bleeding, tracheal perforation

  2. Overall success rate [ Time Frame: within 48 hours of intubation ]
    Include all intubation event


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all the patients present to the emergency department with airway emergency who need intubation

Exclusion Criteria:

  • age below 18 year-old
Contacts and Locations

Locations
Layout table for location information
Taiwan
Taipei City Hospital Zhong-Xing branch Recruiting
Taipei, Taiwan, 100
Contact: Tzu-Yao Hung, MD    886-2-979305599    bryansolitude@gmail.com   
Sponsors and Collaborators
Taipei City Hospital
Tracking Information
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
 (submitted: January 16, 2019)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2019)
  • Immediate complications direct related to intubation process [ Time Frame: through the intubation period, an average of 90 seconds ]
    esophageal intubation, bleeding, tracheal perforation
  • Overall success rate [ Time Frame: within 48 hours of intubation ]
    Include all intubation event
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
Condition  ICMJE
  • Intubation;Difficult
  • Intubation Complication
Intervention  ICMJE
  • Procedure: stylet-assisted epiglottic lifting
    use stylet-equipped enodtracheal tube to lift the epiglottis and pass the endotracheal tube
  • 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
Study Arms  ICMJE
  • Active Comparator: bougie-assisted intubation
    use bougie as guide, intubation with loading endotracheal tube under direct or video laryngoscopy
    Intervention: Device: bougie-assisted intubation
  • Active Comparator: intubation with epiglottic lifting
    Lifting of epiglottis with stylet-equipped endotracheal tube to assist intubation under direct or video laryngoscopy
    Intervention: Procedure: stylet-assisted epiglottic lifting
  • No Intervention: Traditional intubation
    intubation under direct or video laryngoscopy without epiglottis lifting nor bougie-assited
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.
  • Ueda 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. eCollection 2016 Aug.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 16, 2019)
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:

  • all the patients present to the emergency department with airway emergency who need intubation

Exclusion Criteria:

  • age below 18 year-old
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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