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

Intubation;Difficult Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03392766
• Other study ID #: AJIRB-DEV-OBS-17-247
• Status: Completed
• Phase: N/A
• Start date: February 9, 2018
• Est. completion date: April 22, 2019

Study information

• Verified date: April 2019
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 22, 2019
• Est. primary completion date: April 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubation;Difficult
• Thoracic Diseases

Intervention

Device:
• single lumen tube and bronchial blocker
neck collar apply. fibreoptic intubation with single lumen tube and bronchial blocker.
• double lumen tube
neck collar apply. fibreoptic intubation with double lumen tube.

Locations

Country	Name	City	State
Korea, Republic of	Ajou universiry hospital	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	trauma around the glottis	fibreoptic observation of the glottic bleeding.	through study completion, an average of 4 hour
Secondary	complication at the post-anesthesia care unit	hoarseness, sore throat, swallowing difficulty	through study completion, an average of 4 hour