Health Condition 1: J459- Other and unspecified asthma
Conditions
Interventions
Intervention1: Tremoflow: Forced Oscillation Technique (FOT) is a non-invasive, effort-independent method used to assess respiratory system mechanics by superimposing pressure oscillations on spontane
Sponsors
Roundworks Technologies Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: These inclusion criteria ensure that the study sample captures the diversity of clinical presentation (healthy to diseased), age (pediatric to adult), and technical feasibility (physical and cognitive ability to comply with FOT testing), thereby maximizing the reliability, generalizability, and interpretability of the study findings. Age should be more than 5 years Ability to perform FOT testing Informed consent obtained
Exclusion criteria
Exclusion criteria: Participants will be excluded from the study if they meet any of the following criteria. These criteria are intended to ensure participant safety, prevent potential harm, and avoid invalid or unreliable test results due to physiological, psychological, or situational limitations: 1. Acute Respiratory Distress or Exacerbation: a. Individuals currently experiencing a severe respiratory episode (e.g., asthma attack, COPD exacerbation, pneumonia) will be excluded. FOT testing in such patients may provoke further distress and produce highly variable or unreliable results. 2. Inability to Comply with Test Instructions: a. Participants unable to comprehend or follow simple instructions (due to age, cognitive impairment, or severe psychiatric illness) or who cannot maintain proper posture or seal around the mouthpiece during testing will be excluded. Non-cooperation significantly compromises data quality. 3. Recent Thoracic or Upper Abdominal Surgery: a. Any participant who has undergone thoracic or upper abdominal surgery in the past 8 weeks will be excluded. Such procedures may influence respiratory mechanics, cause discomfort during testing, or increase the risk of post-operative complications. 4. Facial or Upper Airway Abnormalities: a. Individuals with facial deformities, cleft palate, or recent facial trauma or surgery that precludes proper mouthpiece use will not be enrolled. Proper seal and airflow are essential for accurate FOT measurement. 5. Severe Cardiovascular Instability: a. Participants with recent myocardial infarction, unstable angina, uncontrolled hypertension, or heart failure NYHA class IV will be excluded. Although FOT is low-risk, even mild procedural stress could exacerbate cardiac conditions in unstable patients. 6. Severe Nausea, Vomiting, or Risk of Aspiration: a. Conditions that increase the risk of aspiration (e.g., active nausea, recent vomiting, impaired swallowing reflex) are contraindications to FOT testing. 7. Known or Suspected Infectious Diseases with Airborne Transmission Risk: a. Participants with confirmed or suspected infectious diseases such as tuberculosis, COVID-19, or influenza will be excluded to prevent cross-contamination and ensure safety for staff and other patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints focus on respiratory impedance parameters derived from Forced Oscillation Technique (FOT) testing. These parameters are selected based on their clinical relevance, reproducibility, and representation of key physiological features of the respiratory systemTimepoint: Estimated Duration: 6 months Interim analysis after 60 participants | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints encompass practical and subjective aspects of device usage, which are crucial for successful clinical implementationTimepoint: Estimated Duration: 6 months Interim analysis after 60 participants | — |
Countries
India
Contacts
Public ContactDr Vaishal Dineshbhai Sheth
Lungs Care Clinic
Outcome results
None listed