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

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

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.

Study Overview

• Status: Completed
• Conditions: Thoracic Diseases; Intubation;Difficult
• Intervention / Treatment: Device: single lumen tube and bronchial blocker; Device: double lumen tube

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, Korea, Republic of
      • Ajou universiry hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single lumen tube and bronchial blocker; neck collar apply. fibreoptic intubation with single lumen tube and brochial blocker	Device: single lumen tube and bronchial blocker; neck collar apply. fibreoptic intubation with single lumen tube and bronchial blocker.
Experimental: Double lumen tube; neck collar apply. fibreoptic intubation with double lumen tube	Device: double lumen tube; neck collar apply. fibreoptic intubation with double lumen tube.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intubation time	the time from the passage of the fibreoptic bronchoscope beyond the teeth, to tracheal tube positioning above the carina.	through study completion, an average of 4 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
insertion time	the time from the passage of the fibreoptic bronchoscope beyond the teeth, to fibreoptic bronchoscope positioning above the carina	through study completion, an average of 4 hour
railroading time	the time from fibreoptic bronchoscope positioning above the carina to tracheal tube positioning above the carina.	through study completion, an average of 4 hour
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.	through study completion, an average of 4 hour
trauma around the glottis	fibreoptic observation of the glottic bleeding.	through study completion, an average of 4 hour
complication at the post-anesthesia care unit	hoarseness, sore throat, swallowing difficulty	through study completion, an average of 4 hour

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Investigators: Principal Investigator: Dae Hee Kim, M.D., Ajou unversity hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2018
• Primary Completion (Actual): April 22, 2019
• Study Completion (Actual): April 22, 2019

Study Registration Dates

• First Submitted: January 2, 2018
• First Submitted That Met QC Criteria: January 4, 2018
• First Posted (Actual): January 8, 2018

Study Record Updates

• Last Update Posted (Actual): April 23, 2019
• Last Update Submitted That Met QC Criteria: April 22, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: difficult intubation; double lumen tube; fibreoptic intubation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Thoracic Diseases
• Other Study ID Numbers: AJIRB-DEV-OBS-17-247

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No