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NCT01626365 Clinical Trial

Thermosoftening of Double-lumen Tube to Reduce Sore Throat

Sore Throat Clinical Trial

Official title:
The Effect of Double-lumen Tube Thermosoftening Before Intubation to Reduce Hoarseness and Sore Throat

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01626365
Other study ID # JHBahk_DLT_thermosoftening
Secondary ID
Status Completed
Phase N/A
First received June 20, 2012
Last updated December 16, 2012
Start date May 2012
Est. completion date December 2012

Study information
Verified date December 2012
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of double-lumen tube thermosoftening before intubation to reduce postoperative hoarseness and sore throat.

Recruitment information / eligibility
Status Completed
Enrollment 154
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria:

- Patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes

Exclusion Criteria:

- Preoperative hoarseness or sore throat

- History of upper airway diseases

- Anticipated difficult airway

- Anesthesia time longer than 6 hours

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• non-thermosoftening
Intubation is performed with a double-lumen tube put into normal saline at room temperature.
• thermosoftening
Intubation is performed with a double lumen tube 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 Postoperative hoarseness up to 3 days after surgery No
Primary postoperative sore throat up to 3 days after surgery No
Secondary Vocal cord injuries up to 1 day after surgery No
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