Actively Recruiting
Effectiveness and Safety of Nasal Herbal Steam Therapy for Post-extubation Respiratory Events: Pragmatic Randomized Controlled Parallel Group Study
Led by Ilsan Cha hospital · Updated on 2025-04-02
66
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of nasal steam therapy compared to routine management for upper respiratory symptoms that happen after endotracheal intubation in adults aged 19 to 69 years who had thyroid gland surgery under anesthesia. The study aims to confirm how well nasal steam therapy works by randomly assigning 66 patients to either a nasal steam therapy group or a routine management group. This is a practical trial where treatments are chosen based on each patient's condition and recorded for comparison. The nasal steam therapy group receives steam inhalation treatment every other day for a total of three sessions, targeting specific acupoints on the face. The routine management group receives usual clinical care, including drugs commonly used to manage upper respiratory symptoms, with treatment decisions made by doctors based on symptom severity and improvement. Treatment lasts for five days, and drug use may continue after the study period if decided by the clinician. Participants will be monitored from enrollment through treatment and follow-up visits, with assessments including the Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) up to day 15. Researchers will also track the incidence and severity of cough and quality of life related to thyroid cancer symptoms. All treatments, symptom changes, and patient-reported outcomes will be recorded to understand the therapies' impact and safety over the study period.
CONDITIONS
Brief Title
Nasal Steam Therapy for Post-extubation Respiratory Events
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 19 and 69 years
- Underwent thyroid gland surgical removal with endotracheal intubation
- American Society of Anesthesiologists (ASA) status I or II
- Developed upper respiratory symptoms after surgery
- Voluntarily agreed to participate and signed informed consent
You will not qualify if you...
- Diagnosed with symptomatic gastroesophageal reflux disease
- Chronic cough lasting more than 3 months before surgery, including bronchial asthma and COPD
- Developed other respiratory infections within the past month
- Taking or needing medications that affect treatment interpretation
- Scheduled for additional major treatments like reoperation, chemotherapy, or radiotherapy during the trial
- Pregnant, breastfeeding, or planning pregnancy during the study
- Expected difficulty complying with treatment, visits, or questionnaires as decided by medical staff
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days
Participants receive either nasal steam therapy every other day for a total of 3 sessions or routine management based on clinical judgment to improve upper respiratory symptoms after surgery.
3 visits for nasal steam therapy or visits as needed for routine management
Duration - 7 days
Participants are monitored for symptom improvement and quality of life after treatment completion.
1 follow-up visit on Day 15
Trial Site Locations
Total: 1 location
1
Ilsan Cha Hospital
Goyang-si, Gyeonggi-do, South Korea, 082-10414
Actively Recruiting
Research Team
J
Jee Young Lee, MD(KMD), PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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