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Clinical Trials/NCT03392766
NCT03392766
Completed
Not Applicable

Comparison of Fiberoptic Intubation Between Double Lumen Tube and Single Lumen Tube in Patients With Semi-rigid Neck Collar Immobilization of the Cervical Spine.

Ajou University School of Medicine1 site in 1 country80 target enrollmentFebruary 9, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intubation;Difficult
Sponsor
Ajou University School of Medicine
Enrollment
80
Locations
1
Primary Endpoint
intubation time
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Many intrathoracic procedures demand optimal collapse of the operative lung to facilitate surgical exposure. Single-lung ventilation can be achieved using a double-lumen tube (DLT), a Univent tube, or an independent bronchial blocker. Insertion of a DLT using a direct laryngoscope can be more difficult than that of single-lumen tube (SLT), especially in patients for whom airway difficulty is anticipated. The safest of the proposed methods involves the placement of an SLT with the aid of an fibreoptic bronchoscope (FOB), following which the SLT is replaced with a DLT using an airway exchange technique in these patients. HumanBroncho® (Insung Medical, Seoul, Korea) is a new silicone DLT with a soft, flexible, non-bevelled, wire-reinforced tip. The oval shape, obtuse angle, and short lateral internal diameter of the bronchial lumen and its flexibility may allow for advancement to the trachea over the FOB with as much as ease as a standard SLT. In the present study, the investigators aimed to test the hypothesis that the HumanBroncho® DLT would be non-inferior to a standard SLT with regard to intubation time over an FOB in patients with semi-rigid neck collar simulating difficult airway.

Registry
clinicaltrials.gov
Start Date
February 9, 2018
End Date
April 22, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ajou University School of Medicine
Responsible Party
Principal Investigator
Principal Investigator

DAE HEE KIM

Assistant Professor

Ajou University School of Medicine

Eligibility Criteria

Inclusion Criteria

  • patients undergoing thoracic surgery requiring one lung ventilation. American Society of Anesthesiologist, Physical Status 1,2

Exclusion Criteria

  • abnormality of upper airway gastroesophageal disease risk of aspiration BMI \> 35

Outcomes

Primary Outcomes

intubation time

Time Frame: through study completion, an average of 4 hour

the time from the passage of the fibreoptic bronchoscope beyond the teeth, to tracheal tube positioning above the carina.

Secondary Outcomes

  • grade of ease of insertion over fibreoptic bronchoscope(through study completion, an average of 4 hour)
  • complication at the post-anesthesia care unit(through study completion, an average of 4 hour)
  • railroading time(through study completion, an average of 4 hour)
  • insertion time(through study completion, an average of 4 hour)
  • trauma around the glottis(through study completion, an average of 4 hour)

Study Sites (1)

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