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

Not Applicable

Completed

• Conditions: Thoracic Diseases; Intubation;Difficult

• Registration Number: NCT03392766
• Lead Sponsor: Ajou University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-02
• Study First Submitted QC: 2018-01-04
• Study First Posted: 2018-01-08
• Study Start: 2018-02-09
• Status Verified: 2019-04
• Primary Completion: 2019-04-22
• Study Completion: 2019-04-22
• Last Update Submitted: 2019-04-22
• Last Update Posted: 2019-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
intubation time	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 Outcome Measures

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

Trial Locations

Locations (1)

Ajou universiry hospital; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of