Clinical trial NCT06840106: Nasal Steam Therapy for Post-extubation Respiratory Events
Official title: Effectiveness and Safety of Nasal Herbal Steam Therapy for Post-extubation Respiratory Events : Pragmatic Randomized Controlled, Parallel Grouped Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thyroid Cancer
Intubation
Keywords: thyroid cancer
post-extubaton
upper respiratory event
Lead sponsor: Ilsan Cha hospital
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 66
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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 in the results of Wisconsin Upper Respiratory Symptom Survey

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.

Eligibility criteria: 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

Primary outcomes:
measure: Wisconsin upper respiratory symptom survey-24, WURSS-24
timeFrame: From enrollment to the end of treatment at Day 8, and follow up visit at Day 15
Secondary outcomes:
measure: Incidence and severity of cough
timeFrame: Day 1, Day 4, Day 8, Day 15
measure: Thyroid cancer-Quality of Life (ThyCa-QoL)
timeFrame: Day 1, Day 4, Day 8, Day 15
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Ilsan Cha Hospital
state: Gyeonggi-do
Study officials:
References: