Effectiveness and Safety of Nasal Herbal Steam Therapy for Post-extubation Respiratory Events : Pragmatic Randomized Controlled, Parallel Grouped Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Wisconsin upper respiratory symptom survey-24, WURSS-24
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor and the statistician will be blinded to evaluate the efficacy.
入排标准
- 年龄范围
- 19 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Nasal steam therapy (Procedure)
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.
干预措施: Routine management strategy (Procedure)
结局指标
主要结局
Wisconsin upper respiratory symptom survey-24, WURSS-24
时间窗: From enrollment to the end of treatment at Day 8, and follow up visit at Day 15
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.
次要结局
- Incidence and severity of cough(Day 1, Day 4, Day 8, Day 15)
- Thyroid cancer-Quality of Life (ThyCa-QoL)(Day 1, Day 4, Day 8, Day 15)
研究者
Jee Young Lee
Assistant professor
Ilsan Cha hospital