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NCT03846713 Clinical Trial

Thermosoftening of Double-lumen Tube for Airway Exchanger Catheter

Intubation Complication Clinical Trial

Official title:
Effect of Thermal-softening of Double-lumen Endobronchial Tubes on Success Rate of Airway Exchange Catheter

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03846713
Other study ID # JHBahk_DLT_AEC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 27, 2017
Est. completion date December 2019

Study information
Verified date February 2019
Source Seoul National University Hospital
Contact Jae-Hyon Bahk, MD, PhD
Phone 82-2-2072-2818
Email bahkjh@snu.ac.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of double-lumen tube thermal-softening before intubation on the success rate of tube exchange by airway exchange catheter.

Recruitment information / eligibility
Status Recruiting
Enrollment 102
Est. completion date December 2019
Est. primary completion date September 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients undergoing thoracic surgery that requires bronchoscopy study before the placement of double-lumen tubes

Exclusion Criteria:

- Preoperative hoarseness or a sore throat

- History of upper airway diseases

- Anticipated difficult airway

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• non-thermosoftening
By using airway exchange catheter, tube exchange is performed from single to double lumen tube that was put into normal saline at room temperature.
• thermosoftening
By using airway exchange catheter, tube exchange is performed from single to double lumen tube that was put into warm normal saline (40°C).

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to intubate Length of time to exchange endotracheal tube from single- to double-lumen tube using airway exchange catheter. Intraoperative (During exchanging single- to double-lumen tube)
Secondary Postoperative hoarseness (4-points scoring) up to 48 hours after surgery
Secondary postoperative sore throat (4-points scoring) up to 48 hours after surgery
Secondary Vocal cord injuries assessed by videolaryngoscope vocal cord injuries observed after tube-exchange up to 1 hour after double-lumen tube extubation
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