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

Overview

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.

Full Title of Study: “Taipei City Hospital ZhongXing Branch, Emergency Department”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 20, 2021

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: bougie-assisted intubation
    • use bougie as guide, intubation with loading endotracheal tube under direct or video laryngoscopy
  • Active Comparator: intubation with epiglottic lifting
    • Lifting of epiglottis with stylet-equipped endotracheal tube to assist intubation under direct or video laryngoscopy
  • No Intervention: Traditional intubation
    • intubation under direct or video laryngoscopy without epiglottis lifting nor bougie-assited

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

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

  • age below 18 year-old

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Taipei City Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hung,Tzu-Yao, Director of emergency department – Taipei City Hospital

References

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. doi: 10.5812/aapm.38507. eCollection 2016 Aug.

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