General AnesthesiaNCT03693417
Heated Circuit on Sore Throat
A study testing Heated circuit on and Heated circuit off in people with General Anesthesia, run by Keimyung University Dongsan Medical Center.
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 endotracheal intubation for general anesthesia. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Heated circuit on and Heated circuit off
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2018to 1 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- Patients scheduled for general anesthesia with 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
No sites are listed yet.
About this study
Official title: Heated Breathing Circuit on Postoperative Sore Throat After 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 endotracheal intubation for general anesthesia.
- Conditions
- General Anesthesia
- Being tested
- Heated circuit on, Heated circuit off
- Keywords
- pharyngitis, intubation, heat
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heated circuit onDevice
Heated circuit will be turned on.
Heated circuit offDevice
Heated circuit will be turned off.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Device: Heated circuit off |
| Heat | Experimental | Not described Receives: Device: Heated 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 hour
Measured: At 24 hour
Secondary outcomes (3)
Number of participants with postoperative sore throat
Measured: At 2, 4, and 24 hour
Number of participants with postoperative hoarseness
Measured: At 2, 4, and 24 hour
Wound pain scores
Visual analogue scales will be used (10: most imaginable pain, 0: no pain).
Measured: At 2, 4, and 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start1 Nov 2018 (estimated)
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 92 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
- NCT03693417
- Sponsor's protocol ID
- HeatPOSTSingle
- Status last verified
- Oct 2018
- First submitted
- 1 Oct 2018
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heated Breathing Circuit on Postoperative Sore Throat After Endobronchial Tube Insertion
- ClinicalTrials.gov ID
- NCT03693417
- Acronym / sponsor ID
- HeatPOSTSingle
- Conditions
- General Anesthesia
- Keywords
- pharyngitis, intubation, heat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 3 Oct 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 endotracheal intubation for general anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Heated circuit off |
| Heat | Experimental | Device: Heated circuit on |
Who may qualify
- Ages
- 19 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 general anesthesia with 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 circuit onHeated circuit will be turned on. | Device | Heat |
| Heated circuit offHeated circuit will be turned off. | Device | Control |
Primary outcome
Number of participants with postoperative sore throat for postoperative 24 hour
Time frame: At 24 hour
3 secondary outcomes
Number of participants with postoperative sore throat
Time frame: At 2, 4, and 24 hour
Number of participants with postoperative hoarseness
Time frame: At 2, 4, and 24 hour
Wound pain scores
Time frame: At 2, 4, and 24 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 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.
Questions about this trial
What is this clinical trial studying?
A study testing Heated circuit on and Heated circuit off in people with General Anesthesia, run by Keimyung University Dongsan Medical Center.
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 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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 hour (time frame: At 24 hour). 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 3 Oct 2018.