Nasal Steam Therapy for Post-extubation Respiratory Events

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура 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
• Процедура 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

Первичные конечные точки

• Wisconsin upper respiratory symptom survey-24, WURSS-24 [Срок оценки: From enrollment to the end of treatment at Day 8, and follow up visit at Day 15]

Вторичные конечные точки (2)

• Incidence and severity of cough [Срок оценки: Day 1, Day 4, Day 8, Day 15]
• Thyroid cancer-Quality of Life (ThyCa-QoL) [Срок оценки: Day 1, Day 4, Day 8, Day 15]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Ilsan Cha Hospital — Goyang-si

Публикации

• 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. PMID 40955847

Идентификаторы

NCT: NCT06840106 · ICICC-CT-24-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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