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

Not Applicable

Completed

• Conditions: Intubation;Difficult
• Interventions: Device: Fibreoptic intubation with silicone double lumen tube; Device: Fibreoptic intubation with PVC double lumen tube

• Registration Number: NCT03889847
• Lead Sponsor: Ajou University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-03-22
• Study First Posted: 2019-03-26
• Study Start: 2019-04-25
• Primary Completion: 2019-12-19
• Study Completion: 2019-12-20
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-17
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
silicone DLT	Fibreoptic intubation with silicone double lumen tube	Fibreoptic intubation with silicone double lumen tube
PVC DLT	Fibreoptic intubation with PVC double lumen tube	Fibreoptic intubation with PVC double lumen tube

Primary Outcome Measures

Name	Time	Method
railroading grade	an average of 2 minutes	grade of ease of railroading over fibreoptic bronchoscope.; 1. no difficulty passing the tube; 2. obstruction while passing the tube, relieved by withdrawal and 90 degree counter-clockwise rotation(2-1) or more than 90 degree rotation(2-2); 3. obstruction necessitating more than one manipulation or external laryngeal manipulation; 4. direct laryngoscope was required

Secondary Outcome Measures

Name	Time	Method
insertion time	an average of 2 minutes	time from insertion of FOB into mouth to tube placement into trachea and left main bronchus
number of patients with complication of hoarseness, sore throat, and swallowing difficulty	an average of 30 minutes	hoarseness, sore throat, swallowing difficulty in post-anesthesia care unit
number of patients with trauma around glottis, observed by FOB	an average of 2minutes	glottic trauma observation through FOB outside the tube
number of patients with tube repositioning during the surgery	an average of 3.5 hours	count of tube repositioning with FOB during the surgery

Trial Locations

Locations (1)

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