HoarsenessNCT01626365
Thermosoftening of Double-lumen Tube to Reduce Sore Throat
A study testing non-thermosoftening and thermosoftening in people with Hoarseness and Sore Throat, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hoarseness, Sore Throat, Vocal Cord Injuries
- What is being tested?
- non-thermosoftening and thermosoftening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes
Who cannot join
- Preoperative hoarseness or sore throat
- History of upper airway diseases
- Anticipated difficult airway
- Anesthesia time longer than 6 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Double-lumen Tube Thermosoftening Before Intubation to Reduce Hoarseness and Sore Throat
The purpose of this study is to investigate the effect of double-lumen tube thermosoftening before intubation to reduce postoperative hoarseness and sore throat.
- Conditions
- Hoarseness, Sore Throat, Vocal Cord Injuries
- Being tested
- non-thermosoftening, thermosoftening
- Keywords
- double-lumen tube, intubation, thermosoftening
- Medical subject headings
- Hoarseness, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-thermosofteningProcedure or surgery
Intubation is performed with a double-lumen tube put into normal saline at room temperature.
thermosofteningProcedure or surgery
Intubation is performed with a double lumen tube put into warm normal saline (40°C).
| Study group | Role | What they receive |
|---|---|---|
| non-thermosoftening | Active comparator | Double-lumen tube is put into a bottle of normal saline at room temperature (25°C) before intubation. Receives: Procedure: non-thermosoftening |
| thermosoftening | Experimental | Double-lumen tube is put into a bottle of warm normal saline (40°C) before intubation. Receives: Procedure: thermosoftening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative hoarseness
Measured: up to 3 days after surgery
postoperative sore throat
Measured: up to 3 days after surgery
Secondary outcomes (1)
Vocal cord injuries
Measured: up to 1 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HoarsenessStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626365
- Sponsor's protocol ID
- JHBahk_DLT_thermosoftening
- Status last verified
- Dec 2012
- First submitted
- 20 Jun 2012
- Last updated
- 18 Dec 2012
- Results posted
- No
Publications
Seo JH, Cho CW, Hong DM, Jeon Y, Bahk JH. The effects of thermal softening of double-lumen endobronchial tubes on postoperative sore throat, hoarseness and vocal cord injuries: a prospective double-blind randomized trial. Br J Anaesth. 2016 Feb;116(2):282-8. doi: 10.1093/bja/aev414.
PubMed 26787799
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Double-lumen Tube Thermosoftening Before Intubation to Reduce Hoarseness and Sore Throat
- ClinicalTrials.gov ID
- NCT01626365
- Acronym / sponsor ID
- JHBahk_DLT_thermosoftening
- Conditions
- Hoarseness, Sore Throat, Vocal Cord Injuries
- Keywords
- double-lumen tube, intubation, thermosoftening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effect of double-lumen tube thermosoftening before intubation to reduce postoperative hoarseness and sore throat.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-thermosoftening | Active comparator | Procedure: non-thermosofteningDouble-lumen tube is put into a bottle of normal saline at room temperature (25°C) before intubation. |
| thermosoftening | Experimental | Procedure: thermosofteningDouble-lumen tube is put into a bottle of warm normal saline (40°C) before intubation. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes
Key exclusion criteria (4 listed)
- Preoperative hoarseness or sore throat
- History of upper airway diseases
- Anticipated difficult airway
- Anesthesia time longer than 6 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-thermosofteningIntubation is performed with a double-lumen tube put into normal saline at room temperature. | Procedure or surgery | non-thermosoftening |
| thermosofteningIntubation is performed with a double lumen tube put into warm normal saline (40°C). | Procedure or surgery | thermosoftening |
Primary outcome
Postoperative hoarseness
Time frame: up to 3 days after surgery
postoperative sore throat
Time frame: up to 3 days after surgery
1 secondary outcome
Vocal cord injuries
Time frame: up to 1 day after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2012.
- Derived from this study: PubMed 26787799Seo JH, Cho CW, Hong DM, Jeon Y, Bahk JH. The effects of thermal softening of double-lumen endobronchial tubes on postoperative sore throat, hoarseness and vocal cord injuries: a prospective double-blind randomized trial. Br J Anaesth. 2016 Feb;116(2):282-8. doi: 10.1093/bja/aev414.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-thermosoftening and thermosoftening in people with Hoarseness and Sore Throat, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative hoarseness (time frame: up to 3 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01626365, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2012.