Nasal Steam Therapy for Post-extubation Respiratory Events (PURE)

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

Study Overview

• Status: Recruiting
• Conditions: Intubation; Thyroid Cancer
• Intervention / Treatment: Procedure: Nasal steam therapy; Procedure: Routine management strategy

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.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jee Young Lee, MD(KMD), PhD; Phone Number: 082-31-782-3113; Email: happiade@chamc.co.kr

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 082-10414
      • Recruiting
      • Ilsan Cha Hospital
      • Contact: Jee Young Lee; Phone Number: 082-31-782-3113; Email: happiade@chamc.co.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nasal Steam therapy strategy; 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	Procedure: Nasal steam therapy; 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
Active Comparator: Routine management strategy; This 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.	Procedure: Routine management strategy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of treatment at Day 8, and follow up visit at Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Day 1, Day 4, Day 8, Day 15
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.	Day 1, Day 4, Day 8, Day 15

Collaborators and Investigators

• Sponsor: Ilsan Cha hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: thyroid cancer; post-extubaton; upper respiratory event
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID Numbers: ICICC-CT-24-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No