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

NCT ID: NCT03392766

Last Updated: 2019-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-09
• Study Completion Date: 2019-04-22

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.

Conditions

Intubation;Difficult; Thoracic Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Single lumen tube and bronchial blocker

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

Group Type: EXPERIMENTAL

single lumen tube and bronchial blocker

Intervention Type: DEVICE

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

Double lumen tube

neck collar apply. fibreoptic intubation with double lumen tube

Group Type: EXPERIMENTAL

double lumen tube

Intervention Type: DEVICE

neck collar apply. fibreoptic intubation with double lumen tube.

Interventions

single lumen tube and bronchial blocker

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

Intervention Type: DEVICE

double lumen tube

neck collar apply. fibreoptic intubation with double lumen tube.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ajou University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

DAE HEE KIM

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dae Hee Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ajou unversity hospital

Locations

Ajou universiry hospital

Suwon, Gyeonggi-do, South Korea

Countries

South Korea

References

Kang S, Chae YJ, Kim DH, Bae SY, Yoo JY. Comparison of silicone double-lumen tube and polyvinyl chloride single-lumen tube in fiberoptic tracheal intubation on a difficult airway model: a randomized controlled non-inferiority trial. Sci Rep. 2023 May 24;13(1):8397. doi: 10.1038/s41598-023-35635-1.

Reference Type: DERIVED

PMID: 37225777 (View on PubMed)

Other Identifiers

AJIRB-DEV-OBS-17-247

Identifier Type: -

Identifier Source: org_study_id