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 @ 10:17 PM
Ignite Modification Date:
2025-12-24 @ 10:17 PM
NCT ID:
NCT07075835
Eligibility Criteria:
Inclusion Criteria:
* Verified severe (30% \< forced expiratory volume in 1 second \< 49% or lung diffusion capacity \< 40%) and moderate (50% \< forced expiratory volume in 1 second \< 59% or lung diffusion capacity 40-60%) ventilation disorders in patients with different chronic lung diseases who are on optimal basic therapy (according to current clinical guidelines) and are in a stable state of respiratory disease (1 month without exacerbations)
* Signed informed voluntary consent to participate in the study
Exclusion Criteria:
* A history of thrombophlebitis and/or phlebitis
* Thoracic or abdominal aortic aneurysm
* Severe pathology of the valvular heart (Area of orifice in stenoses: Aortic and tricuspid valves: \< 1.0 cm²; Mitral valve: \< 1.5 cm². Pulmonary valve: pressure gradient between right ventricle and pulmonary artery \> 50 mmHg; In case of insufficiency, regurgitation of grade 3-4 according to echocardiography)
* Pregnancy
* High pulmonary hypertension (grade 2-3; \>45 mmHg)
* Catheterization cardiac arrest performed within 2-4 weeks before the study
* Tachyarrhythmias (device Myocard-12)
* Uncontrolled arterial hypertension (\>180/110 mmHg when treated with 3 drugs, one of which is a diuretic)
* Hemorrhagic conditions critical arterial ischemia of the lower extremities (Stages 3 and 4 of chronic arterial insufficiency of the lower extremities according to the Pokrovsky-Fontaine classification are patients with pain at rest and with trophic or infectious-inflammatory changes in the tissues of the extremities
* Dilatation of the heart cavities (device Philips iU22 Ultrasound)
* Ejection fraction \<50% (device Philips iU22 Ultrasound)
* Level of NT-pro BNP \> 125 pg/ml
* A history of myocardial infarction
* Severe renal (glomerular filtration rate \<30 ml/min/1,73 m2) failure
* Hepatic failure (B and C on the Child-Pugh scale)
* Poor tolerance of the procedure (side effects that disrupt the patient's condition and prevent the continuation of procedures (local: hyperemia, pain, and itching in the area of the cuff application; systemic: hypertensive reaction, dizziness)
* Low patient compliance (skipping more than 3 procedures), refusal to participate in the study
* Exacerbation of the underlying disease during the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
74 Years
Study:
NCT07075835
Study Brief:
Protocol Section:
NCT07075835