A registry of data on lung oscillometry techniques (technique used to determine any obstruction or restriction in the lungs) of healthy participants, asthamatics, patients with COPD or any other respiratory disorders.
- Conditions
- NAOther and unspecified asthma, (2) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, (3) ICD-10 Condition: J479||Bronchiectasis, uncomplicated, (4) ICD-10 Condition: J439||Emphysema, unspecified,
- Registration Number
- CTRI/2021/12/038546
- Lead Sponsor
- Self Supported
- Brief Summary
Study Synopsis
**A) Title**: Lung Oscillometry Registry for patients with various Respiratory Disorders and healthy subjects (LEAD Study)
**B) Background:** To diagnose Obstructive Airways Disease (OADs), it is crucial to perform lung function tests. Not only do the lung function tests support to diagnose OADs, but also help to identify the severity of the obstruction and decide the pharmacotherapy based on the severity. The response to the administered intervention can also be monitored. Chest Physicians and other health care professionals have been using the conventional spirometer to diagnose Obstructive Airways Diseases (OADs) since many decades. But spirometry is not an easy test to be performed as it requires patient co-operation. In addition, spirometry cannot be performed in children below 5 years of age as well as the elderly people who have cognitive and physical impairment. Oscillometry techniques have proved to be an alternative sensitive diagnostic test to spirometry. Oscillometry technique is a non-invasive technique use to diagnose obstruction in the airways, which requires minimal patient co-operation. Unfortunately, unlike spirometry, there are no reference values or cut-offs available for the Indian population i.e., healthy and for patients with different respiratory diseases of different age group. Therefore, through the ARISE network, the LEAD study will form a lung oscillometry registry, whose data will be used to derive reference equations or cut-offs for the Indian as well as other countries healthy and with respiratory diseases, adult and paediatric population. Which in turn will contribute to the accuracy in diagnosing respiratory diseases by the physicians.
**C) Research Question:** What are the lung oscillometry values/ Predicted values/cut-offs/ Reference value for healthy adults and children as well as in patients with asthma, COPD, interstitial lung diseases and other respiratory diseases.
**D) Aim of the Study:** To develop a lung Oscillometry registry for Healthy adults and children to derive reference values as well as patients suffering with various respiratory disorders, such as asthma, COPD, interstitial lung diseases and other lung diseases so that cut-off values for various lung oscillometry indices can be generated.
**E) Study Design:** Cross-sectional, observational clinic or hospital- based prospective study. Study Code: ARISE/LEAD/01/2021 INTERNATIONAL NETWORK FOR LUNG OSCILLOMETRY RESEARCH Page 3 of 16 Registry for Lung Oscillometry Research Version 01 22 October 2021
**F) Study Population:** The registry will include oscillometry data from healthy subjects and patients with asthma, COPD, ILD and other respiratory disorders across different states in India as well as outside India.
**G) Data Collection variables (Adults):** (See Section 5.0 for detailed variables) 1. Demographics 2. Risk Factors: Educational Qualifications, Smoking Status, Type of residence, Type of cooking fuel, Occupation, Mosquito repellents and Medical History 3. Symptoms: Cough, Shortness of breath, Wheeze and Chest Tightness 4. COVID- 19 related questions 5. To be filled by Doctor: Final diagnosis 6. Spirometry Values 7. Lung Oscillometry Values 8. Other diagnostic reports to be uploaded if available
**H) Data Management:** All the data will be entered at the study sites in an electronic format, through an app developed exclusively to enter data related to the LEAD study. At the back end, data will be downloaded in an excel format at the ARISE data coordination centre without the identification of the study participant. All the data will be cleaned and checked for completeness by the data management team at ARISE. Once complete data is received it will be locked and taken for analysis.
**I) Statistical Analysis plan:** The preliminary analysis will be based on the descriptive statistics which includes frequency and percentages for categorical variables and mean and SD for continuous variable.
**J) Outcomes expected:** • Predicted values/cut-offs/ Reference values for the Antlia FOT device for the South-East Asian adult and paediatric populations in patients with Asthma, COPD, ILD and other respiratory diseases and healthy participants will be derived • Predicted values/cut-offs/ Reference values for the IOS for the adult and paediatric population in patients with Asthma, COPD, other ILD and other respiratory diseases and healthy participants will be derived
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 500
a)Healthy male and female subjects above the age of 5 years and adults b) Children > 5 years and adults of all ages having respiratory diseases including asthma, COPD, Interstitial lung disease, bronchiectasis.
Willingness to participate.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Predicted values/cut-offs/ Reference values for the Antlia FOT device for the South-East End of study Asian adult populations for Asthma, COPD, other ILD patients and healthy participants will End of study be derived End of study 2. Predicted values/cut-offs/ Reference values for the IOS for the adult Indian population in End of study patients with Asthma, COPD, other ILD patients and healthy participants will be derived End of study
- Secondary Outcome Measures
Name Time Method NA NA
Trial Locations
- Locations (8)
CGHS. Wellness Centre No. -5 . Pune, Maharashtra
🇮🇳Pune, MAHARASHTRA, India
Chest Research and Training Pvt Ltd
🇮🇳Pune, MAHARASHTRA, India
Dr Indus New Born and Childcare centre
🇮🇳(Suburban), MAHARASHTRA, India
Kalyan Hospital Vadodara, Gujarat
🇮🇳Vadodara, GUJARAT, India
Om Sai Childrens hospital
🇮🇳Kolhapur, MAHARASHTRA, India
Sanjivanee clinic
🇮🇳Raigarh, MAHARASHTRA, India
Shree Nursing Home
🇮🇳Aurangabad, MAHARASHTRA, India
Vhora Chest Clinic
🇮🇳Pune, MAHARASHTRA, India
CGHS. Wellness Centre No. -5 . Pune, Maharashtra🇮🇳Pune, MAHARASHTRA, IndiaDr Nagesh DhadgePrincipal investigator9822327445ndhadge@hotmail.com