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

Ilsan Cha hospital

Status: Enrolling

Conditions: Thyroid Cancer; Intubation

Treatments: Procedure: Nasal steam therapy; Procedure: Routine management strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT06840106

ICICC-CT-24-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 19 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Nasal Steam therapy strategy

Experimental group

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

Treatment:

Procedure: Nasal steam therapy

Routine management strategy

Active Comparator group

Description:

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.

Treatment:

Procedure: Routine management strategy