Lung SurgeryNCT03689127
Heated Breathing Circuit on Postoperative Sore Throat After Double-lumen Endobronchial Tube Insertion
A study testing Heated breathing circuit on and Heated breathing circuit off in people with Lung Surgery, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of heated breathing circuit in patients undergoing double-lumen endotracheal intubation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Surgery
- What is being tested?
- Heated breathing circuit on and Heated breathing circuit off
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2018to Nov 2019
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- Patients scheduled for double-lumen endotracheal intubation
Who cannot join
- Difficult airway
- Mallampatti scores greater than 2
- Recent sore throat
- Cervical spine disease
- Recent upper respiratory infection
- Recent analgesics
Show all 9Show fewer
- History of head and neck surgery
- Friable teeth
- Multiple intubation attempts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Heated Breathing Circuit on Postoperative Sore Throat in Patients Undergoing Double-lumen Endobronchial Tube Insertion
This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of heated breathing circuit in patients undergoing double-lumen endotracheal intubation.
- Conditions
- Lung Surgery
- Being tested
- Heated breathing circuit on, Heated breathing circuit off
- Keywords
- intubation, pharyngitis
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heated breathing circuit onDevice
Heated breathing circuit will be turned on.
Heated breathing circuit offDevice
Heated breathing circuit will be turned off.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Heated breathing circuit will be turned off. Receives: Device: Heated breathing circuit off |
| Heat | Experimental | Heated breathing circuit will be turned on. Receives: Device: Heated breathing circuit on |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with postoperative sore throat for postoperative 24 h
Measured: At 24 hours
Secondary outcomes (6)
Number of participants with postoperative sore throat
Measured: At 1, 6, and 24 hours
Postoperative sore throat scores
Measured: At 1, 6, and 24 hours
Number of participants with postoperative hoarseness
Measured: At 1, 6, and 24 hours
Number of participants with postoperative shivering
Measured: At 1, 6, and 24 hours
Wound pain scores
Visual anlogue scales will be used (10: most imaginable pain, 0: no pain).
Measured: At 1, 6, and 24 hours
Jaw discomfort scores
Visual anlogue scales will be used (10: most imaginable pain, 0: no pain).
Measured: At 1, 6, and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study startNov 2018 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung SurgeryStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun-Chang Kim, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689127
- Sponsor's protocol ID
- Heated Circuit POST
- Status last verified
- Sep 2018
- First submitted
- 27 Sep 2018
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Heated Breathing Circuit on Postoperative Sore Throat in Patients Undergoing Double-lumen Endobronchial Tube Insertion
- ClinicalTrials.gov ID
- NCT03689127
- Acronym / sponsor ID
- Heated Circuit POST
- Conditions
- Lung Surgery
- Keywords
- intubation, pharyngitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 28 Sep 2018 (actual)
- 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.
This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of heated breathing circuit in patients undergoing double-lumen endotracheal intubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Heated breathing circuit offHeated breathing circuit will be turned off. |
| Heat | Experimental | Device: Heated breathing circuit onHeated breathing circuit will be turned on. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-III
- Patients scheduled for double-lumen endotracheal intubation
Key exclusion criteria (9 listed)
- Difficult airway
- Mallampatti scores greater than 2
- Recent sore throat
- Cervical spine disease
- Recent upper respiratory infection
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 |
|---|---|---|
| Heated breathing circuit onHeated breathing circuit will be turned on. | Device | Heat |
| Heated breathing circuit offHeated breathing circuit will be turned off. | Device | Control |
Primary outcome
Number of participants with postoperative sore throat for postoperative 24 h
Time frame: At 24 hours
6 secondary outcomes
Number of participants with postoperative sore throat
Time frame: At 1, 6, and 24 hours
Postoperative sore throat scores
Time frame: At 1, 6, and 24 hours
Number of participants with postoperative hoarseness
Time frame: At 1, 6, and 24 hours
Number of participants with postoperative shivering
Time frame: At 1, 6, and 24 hours
Wound pain scores
Time frame: At 1, 6, and 24 hours
Jaw discomfort scores
Time frame: At 1, 6, and 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heated breathing circuit on and Heated breathing circuit off in people with Lung Surgery, run by Keimyung University Dongsan Medical Center 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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Sep 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun Chang Kim (+821028862876, onidori1979@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with postoperative sore throat for postoperative 24 h (time frame: At 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2018.