Nasal Steam Therapy for Post-extubation Respiratory Events
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-69
SponsorIlsan Cha hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Nasal steam therapy
Procedure/SurgeryNasal 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
Routine management strategy
Procedure/SurgeryDepending 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 the current clinical guidelines.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Nasal Steam therapy strategyExperimental treatment 1 intervention
Group B: Routine management strategyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Wisconsin upper respiratory symptom survey-24, WURSS-24
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.
Time frame
From enrollment to the end of treatment at Day 8, and follow up visit at Day 15Secondary outcomes
1
Incidence and severity of cough
* The number of times the participant experienced coughing during the day will be recorded. * The degree of discomfort in your daily life due to coughing will be assessed using the numeric rating scale (NRS). On the NRS, the patient selects a number from 0 to 10 that best represents their current level of discomfort (0 being no discomfort, 10 being the worst discomfort imaginable).
Time frame
Day 1, Day 4, Day 8, Day 152
Thyroid cancer-Quality of Life (ThyCa-QoL)
\- THYCA-QoL is a health-related quality of life questionnaire developed for thyroid cancer and thyroid cancer survivors. It was developed using methodologically proven standard guidelines and is a validated questionnaire that can improve symptoms, treatment, aftercare, and disease experience of thyroid cancer survivors.
Time frame
Day 1, Day 4, Day 8, Day 15Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov