Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-24 @ 2:59 PM
NCT ID:
NCT07047859
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis : Confirmed autonomic nervous dysfunction (including palmar hyperhidrosis, craniofacial hyperhidrosis, or facial blushing).
2. Age : ≥18 years and ≤55 years.
3. Cardiopulmonary Function :
Normal preoperative chest CT scan and electrocardiogram (ECG).
4. Performance Status : ECOG score (see Attachment 1) of 0-1, indicating good clinical fitness and ability to perform daily activities independently.
5. Informed Consent : Patients and their families fully understand the study's purpose, procedures, risks, and potential benefits, voluntarily sign the Informed Consent Form, and agree to participate.
Exclusion Criteria:
1\. Abnormal Preoperative ECG :
1. Severe arrhythmias:
1. Type II second-degree or higher atrioventricular block.
2. Symptomatic ventricular arrhythmias.
3. Uncontrolled supraventricular arrhythmias (resting heart rate \>100 bpm). These may cause inadequate cardiac output, hypoperfusion of vital organs, and increased surgical risk.
2. Myocardial ischemia or infarction:
1. ECG showing ST-segment elevation/depression, T-wave inversion.
2. Pathological Q-waves indicating myocardial infarction. 2. Abnormal Chest CT :
1\) Severe pulmonary infections (e.g., lobar pneumonia, empyema) with symptoms like fever, cough, dyspnea. Surgery increases infection risk and may lead to atelectasis or respiratory failure.
2\) Pneumothorax or tension pneumothorax:
1. Significant lung collapse causing dyspnea.
2. Tension pneumothorax requiring immediate chest tube drainage. 3) Pleural effusion (moderate/large volume): Causes dyspnea or mediastinal shift; surgery may worsen respiratory function.
3\. Hyperthyroidism-induced facial blushing or generalized hyperhidrosis. 4. Anesthesia Contraindications : Allergy to anesthetics or high-risk conditions (severe pulmonary/cardiac dysfunction).
5\. Cognitive/Psychiatric Impairment : Inability to provide informed consent or understand study risks.
6\. Non-Compliance with Follow-up : Inability to adhere to postoperative visits.
7\. Immunodeficiency Disorders : Severe immunodeficiency, AIDS, or organ transplant history.
8\. Frailty/Advanced Age : Elderly patients with comorbidities or functional decline unfit for surgery.
9\. Severe Organ Dysfunction : Cirrhosis, renal failure, or inability to tolerate surgery/recovery.
10\. Active Infections : Under antibiotic treatment for pneumonia, tuberculosis, or bacterial infections.
11\. Uncontrolled Diabetes : Poor glycemic control with complications (retinopathy, diabetic foot).
12\. Concurrent Clinical Trials : Participation in other interventional studies affecting results.
13\. Severe Malnutrition : Significant weight loss or nutritional deficiency increasing anesthesia/surgical risks.
14\. Hematologic Disorders : Anemia, thrombocytopenia, or coagulopathies affecting hemostasis/recovery.
15\. Severe Chronic Respiratory Failure : Long-term ventilator dependence or tracheostomy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT07047859
Study Brief:
Protocol Section:
NCT07047859