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Fiberoptic Bronchoscope of Double Lumen Tube and Single Lumen Tube in Patients With Semi-regid Neck Collar.

Primary Purpose

Intubation;Difficult, Thoracic Diseases

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
single lumen tube and bronchial blocker
double lumen tube
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Intubation;Difficult focused on measuring fibreoptic intubation, double lumen tube, difficult intubation

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ajou universiry hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Single lumen tube and bronchial blocker

Double lumen tube

Arm Description

neck collar apply. fibreoptic intubation with single lumen tube and brochial blocker

neck collar apply. fibreoptic intubation with double lumen tube

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

insertion time
the time from the passage of the fibreoptic bronchoscope beyond the teeth, to fibreoptic bronchoscope positioning above the carina
railroading time
the time from fibreoptic bronchoscope positioning above the carina to tracheal tube positioning above the carina.
grade of ease of insertion over fibreoptic bronchoscope
1, no difficulty passing the tube; 2, obstruction while passing the tube, relieved by withdrawal and a 90° counter-clockwise rotation; 3, obstruction necessitating more than one manipulation or external laryngeal manipulation; 4, direct laryngoscopy was required.
trauma around the glottis
fibreoptic observation of the glottic bleeding.
complication at the post-anesthesia care unit
hoarseness, sore throat, swallowing difficulty

Full Information

First Posted
January 2, 2018
Last Updated
April 22, 2019
Sponsor
Ajou University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03392766
Brief Title
Fiberoptic Bronchoscope of Double Lumen Tube and Single Lumen Tube in Patients With Semi-regid Neck Collar.
Official Title
Comparison of Fiberoptic Intubation Between Double Lumen Tube and Single Lumen Tube in Patients With Semi-rigid Neck Collar Immobilization of the Cervical Spine.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 9, 2018 (Actual)
Primary Completion Date
April 22, 2019 (Actual)
Study Completion Date
April 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation;Difficult, Thoracic Diseases
Keywords
fibreoptic intubation, double lumen tube, difficult intubation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single lumen tube and bronchial blocker
Arm Type
Experimental
Arm Description
neck collar apply. fibreoptic intubation with single lumen tube and brochial blocker
Arm Title
Double lumen tube
Arm Type
Experimental
Arm Description
neck collar apply. fibreoptic intubation with double lumen tube
Intervention Type
Device
Intervention Name(s)
single lumen tube and bronchial blocker
Intervention Description
neck collar apply. fibreoptic intubation with single lumen tube and bronchial blocker.
Intervention Type
Device
Intervention Name(s)
double lumen tube
Intervention Description
neck collar apply. fibreoptic intubation with double lumen tube.
Primary Outcome Measure Information:
Title
intubation time
Description
the time from the passage of the fibreoptic bronchoscope beyond the teeth, to tracheal tube positioning above the carina.
Time Frame
through study completion, an average of 4 hour
Secondary Outcome Measure Information:
Title
insertion time
Description
the time from the passage of the fibreoptic bronchoscope beyond the teeth, to fibreoptic bronchoscope positioning above the carina
Time Frame
through study completion, an average of 4 hour
Title
railroading time
Description
the time from fibreoptic bronchoscope positioning above the carina to tracheal tube positioning above the carina.
Time Frame
through study completion, an average of 4 hour
Title
grade of ease of insertion over fibreoptic bronchoscope
Description
1, no difficulty passing the tube; 2, obstruction while passing the tube, relieved by withdrawal and a 90° counter-clockwise rotation; 3, obstruction necessitating more than one manipulation or external laryngeal manipulation; 4, direct laryngoscopy was required.
Time Frame
through study completion, an average of 4 hour
Title
trauma around the glottis
Description
fibreoptic observation of the glottic bleeding.
Time Frame
through study completion, an average of 4 hour
Title
complication at the post-anesthesia care unit
Description
hoarseness, sore throat, swallowing difficulty
Time Frame
through study completion, an average of 4 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dae Hee Kim, M.D.
Organizational Affiliation
Ajou unversity hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou universiry hospital
City
Suwon
State/Province
Gyeonggi-do
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Fiberoptic Bronchoscope of Double Lumen Tube and Single Lumen Tube in Patients With Semi-regid Neck Collar.

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