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

Intubation;Difficult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03889847
• Other study ID #: AJIRB-DEV-THE-18-44-
• Status: Completed
• Phase: N/A
• Start date: April 25, 2019
• Est. completion date: December 20, 2019

Study information

• Verified date: January 2021
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 20, 2019
• Est. primary completion date: December 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubation;Difficult

Intervention

Device:
• Fibreoptic intubation with silicone double lumen tube
Fibreoptic intubation with silicone double lumen tube
• Fibreoptic intubation with PVC double lumen tube
Fibreoptic intubation with PVC 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	railroading grade	grade of ease of railroading over fibreoptic bronchoscope.; no difficulty passing the tube; obstruction while passing the tube, relieved by withdrawal and 90 degree counter-clockwise rotation(2-1) or more than 90 degree rotation(2-2); obstruction necessitating more than one manipulation or external laryngeal manipulation; direct laryngoscope was required	an average of 2 minutes
Secondary	insertion time	time from insertion of FOB into mouth to tube placement into trachea and left main bronchus	an average of 2 minutes
Secondary	number of patients with trauma around glottis, observed by FOB	glottic trauma observation through FOB outside the tube	an average of 2minutes
Secondary	number of patients with tube repositioning during the surgery	count of tube repositioning with FOB during the surgery	an average of 3.5 hours
Secondary	number of patients with complication of hoarseness, sore throat, and swallowing difficulty	hoarseness, sore throat, swallowing difficulty in post-anesthesia care unit	an average of 30 minutes