Comparison of Fiberoptic Bronchoscopic Intubation Between Silicone and Polyvinylchloride Double Lumen Tube.

NCT ID: NCT03889847

Last Updated: 2021-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-25
• Study Completion Date: 2019-12-20

Brief Summary

One lung ventilation (OLV) is required during thoracic procedure such as lung and esophagus surgery, and carried out by double lumen tube(DLT). Direct insertion of DLT over a fibreoptic bronchoscope (FOB) is considered more difficult and traumatic than that of a single-lumen tube. Recently, One recent simulation study demonstrated that a soft silicone DLT with a flexible, wire-reinforced bronchial tip (Fuji-Phycon tube) may shorten the time to intubation via tube exchange when compared with less compliant, polyvinyochloride(PVC) DLTs such as the Shilly or Rusch DLT. 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 easier than the Shilly tube.

In the present study, The investigators aimed to test the hypothesis that the silicone DLT would be easier than PVC DLT with regard to railroading grade over an FOB. Investigators further aimed to compare the intubation time over the FOB between the silicone DLT and PVC DLT.

Conditions

Intubation;Difficult

Study Design

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

Study Groups

silicone DLT

Fibreoptic intubation with silicone double lumen tube

Group Type: EXPERIMENTAL

Fibreoptic intubation with silicone double lumen tube

Intervention Type: DEVICE

Fibreoptic intubation with silicone double lumen tube

PVC DLT

Fibreoptic intubation with PVC double lumen tube

Group Type: EXPERIMENTAL

Fibreoptic intubation with PVC double lumen tube

Intervention Type: DEVICE

Fibreoptic intubation with PVC double lumen tube

Interventions

Fibreoptic intubation with silicone double lumen tube

Fibreoptic intubation with silicone double lumen tube

Intervention Type: DEVICE

Fibreoptic intubation with PVC double lumen tube

Fibreoptic intubation with PVC double lumen tube

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• patients undergoing thoracic surgery and one lung ventilation American Society of Anesthesiologist physical status 1,2

Exclusion Criteria

• abnormal upper airway, gastrointestinal 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

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dae Hee Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Locations

Ajou universiry hospital

Suwon, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

AJIRB-DEV-THE-18-44-

Identifier Type: -

Identifier Source: org_study_id