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Thyroid CancerPURENCT06840106

Nasal Steam Therapy for Post-extubation Respiratory Events

A study testing Nasal steam therapy and Routine management strategy in people with Thyroid Cancer and Intubation, run by Ilsan Cha hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The effect of symptom improvement of nasal steam strategy compared to routine management strategy for upper respiratory symptoms occurring after endotracheal intubation in patients aged 19 years or older who underwent surgical removal under anesthesia requiring endotracheal intubation was evaluated by the difference… Read more about this study

Who is it for?
Ages 19 to 69 years
Conditions the study is for
Thyroid Cancer, Intubation
What is being tested?
Nasal steam therapy and Routine management strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteSouth Korea
Study dates
18 Feb 2025to 12 May 2025
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 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age of 19 to 69 years
  • Those who underwent surgical removal of the thyroid gland under endotracheal intubation due to a thyroid tumor
  • American Society of Anesthesiologists (ASA) status I or II
  • Those who developed upper respiratory symptoms after surgery ⑤ Voluntarily decided to participate in this clinical trial and signed the informed consent form

Who cannot join

  • Those diagnosed with symptomatic gastroesophageal reflux disease
  • Chronic cough lasting for more than 3 months prior to surgery, including bronchial asthma and chronic obstructive pulmonary disease (COPD)
  • Those who developed other respiratory infections within the past month ④ Those who are taking or are required to take other medications that may interfere with the interpretation of the treatment effect or results
  • Those who are scheduled to undergo additional major treatments such as reoperation, chemotherapy, and radiotherapy during the clinical trial period ⑥ Pregnant women, breastfeeding women, and those who plan to become pregnant during the study period ⑦ Others who are expected to have difficulty complying with the treatment, visits, and questionnaires stipulated in this protocol at the discretion of the medical staff

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Ilsan Cha Hospital

    Goyang-si, Gyeonggi-do, 082-10414

Other trials in South Korea

About this study

Official title: Effectiveness and Safety of Nasal Herbal Steam Therapy for Post-extubation Respiratory Events : Pragmatic Randomized Controlled, Parallel Grouped Study

The effect of symptom improvement of nasal steam strategy compared to routine management strategy for upper respiratory symptoms occurring after endotracheal intubation in patients aged 19 years or older who underwent surgical removal under anesthesia requiring endotracheal intubation was evaluated by the difference in the results of Wisconsin Upper Respiratory Symptom Survey

Read the detailed description

This study aims to confirm the comparative effectiveness of nasal steam therapy by conducting a practical randomized controlled clinical trial comparing 66 patients complaining of upper respiratory symptoms with patients treated with a nasal steam therapy strategy (33 patients) and patients treated with a routine management strategy (33 patients).

This study is a practical clinical study, and only randomly assigns patients to two groups: nasal steam therapy strategy and routine management strategy. The specific treatment method used is not determined in advance. The specific treatment is performed according to the clinical judgment according to the patient's condition. All treatment methods used during the study are recorded in the case report and compared.

The treatment will be administered for a total of 5 days, and drug treatment may not be discontinued after the study period at the clinician's discretion.

Being tested
Nasal steam therapy, Routine management strategy
Keywords
thyroid cancer, post-extubaton, upper respiratory event
Medical subject headings
Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nasal steam therapyProcedure or surgery

    Nasal steam therapy is performed once a every other day for a total of 3three times. The steam inhalation stimulates the acupoints of bilateral LI20, EX-HN8, and EX-HN9

  • Routine management strategyProcedure or surgery

    Depending on the patient's symptoms and degree of improvement, the clinician may utilize all drugs currently used in clinical practice to improve upper respiratory symptoms, if necessary. All drugs that fall under the Anatomical Therapeutic Chemical Classification System (ATC) codes of non-disease treatment (R01), throat disease treatment (R02), lung disease or expectorant (R03, R05), and other respiratory organ drugs (R06, R07) and other drugs. The usage and dosage should be within the range of the current clinical guidelines.

Study groups in NCT06840106
Study groupRoleWhat they receive
Nasal Steam therapy strategyExperimentalNasal steam therapy is performed once a every other day for a total of 3three times. The steam inhalation stimulates the acupoints of bilateral LI20, EX-HN8, and EX-HN9
Receives: Procedure: Nasal steam therapy
Routine management strategyActive comparatorThis study is a practical clinical study, and the selection of drugs and other treatment methods will be based on the doctor's clinical judgment regarding the patient's symptoms, degree of improvement, etc. Drug administration or patient education will be implemented according to symptoms. Depending on the patient's symptoms and degree of improvement, the clinician may utilize all drugs currently used in clinical practice to improve upper respiratory symptoms, if necessary. All drugs that fall under the Anatomical Therapeutic Chemical Classification System (ATC) codes of non-disease treatment (R01), throat disease treatment (R02), lung disease or expectorant (R03, R05), and other respiratory organ drugs (R06, R07) and other drugs that clinicians orally administer in current clinical practice for the purpose of improving upper respiratory symptoms will be collected.
Receives: Procedure: Routine management strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Wisconsin upper respiratory symptom survey-24, WURSS-24

    WURSS is a questionnaire mainly used to evaluate symptoms of acute upper respiratory tract infection, and is divided into WURSS-11, WURSS-21, WURSS-24, WURSS-44, and WURSS-Kids versions. In this study, WURSS-24 will be used to evaluate the degree of daily symptom improvement by dividing it into items of symptoms, quality of life, and overall satisfaction, and 24 questions on a 7-point Likert scale. The most severe level is evaluated as 7 points, the least level as 1 point, and in the case of symptoms and quality of life that may be lost, 0 points are additionally recorded when the symptoms are lost.

    Measured: From enrollment to the end of treatment at Day 8, and follow up visit at Day 15

Secondary outcomes (2)

  1. Incidence and severity of cough

    • The number of times the participant experienced coughing during the day will be recorded.
    • The degree of discomfort in your daily life due to coughing will be assessed using the numeric rating scale (NRS). On the NRS, the patient selects a number from 0 to 10 that best represents their current level of discomfort (0 being no discomfort, 10 being the worst discomfort imaginable).

    Measured: Day 1, Day 4, Day 8, Day 15

  2. Thyroid cancer-Quality of Life (ThyCa-QoL)

    • THYCA-QoL is a health-related quality of life questionnaire developed for thyroid cancer and thyroid cancer survivors. It was developed using methodologically proven standard guidelines and is a validated questionnaire that can improve symptoms, treatment, aftercare, and disease experience of thyroid cancer survivors.

    Measured: Day 1, Day 4, Day 8, Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2025
  2. Study start18 Feb 2025
  3. Primary completion12 May 2025
  4. Study completion12 May 2025

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Nasal steam therapy is performed once a every other day for a total of 3three times. The steam inhalation stimulates the acupoints of bilateral LI20, EX-HN8, and EX-HN9
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06840106
Sponsor's protocol ID
ICICC-CT-24-01
Acronym
PURE
Status last verified
Nov 2026
First submitted
21 Jan 2025
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: This study is part of a national project and data will be provided based on the decision of the Korea Health Industry Development Institute under the Ministry of Health and Welfare.

Publications

  • Hong SE, Hyun MH, Lee SH, Kim BW, Kim HJ, Ko EJ, Lee JY. Effectiveness and Safety of Nasal Herbal Steam Therapy for Post-Extubation Respiratory Symptoms: A Methodology of Pragmatic Randomized Controlled, Parallel Grouped Study. Integr Cancer Ther. 2025 Jan-Dec;24:15347354251375469. doi: 10.1177/15347354251375469. Epub 2025 Sep 16.

    PubMed 40955847

Questions about this trial

What is this clinical trial studying?

A study testing Nasal steam therapy and Routine management strategy in people with Thyroid Cancer and Intubation, run by Ilsan Cha 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 4 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 6 Nov 2026. 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?

Wisconsin upper respiratory symptom survey-24, WURSS-24 (time frame: From enrollment to the end of treatment at Day 8, and follow up visit at Day 15). 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 NCT06840106, 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 6 Nov 2026.

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