| CTRI Number |
CTRI/2025/03/082670 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Clinical application of Forced Oscillometry In Patients with Interstitial Lung Disease. |
|
Scientific Title of Study
|
A Study of Characteristics of Forced Oscillometry In Patients with Interstitial Lung Disease. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Heyma krishna Manoharan |
| Designation |
senior resident |
| Affiliation |
AIIMS Rajkot, Gujarat |
| Address |
Room no 63,
Department of Pulmonary medicine
All India Institute of Medical Sciences Rajkot
Village khandheri,
Tehsil-Paddhari,
District- Rajkot Room NO 63,
Department of Pulmonary medicine
All India Institute of Medical Sciences Rajkot
Village khandheri,
Tehsil- Paddhari,
District- Rajkot Rajkot GUJARAT 360110 India |
| Phone |
9131875109 |
| Fax |
|
| Email |
heymakrishna1993@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Kunal Deokar |
| Designation |
Assistant professor |
| Affiliation |
AIIMS Rajkot, Gujarat |
| Address |
Room no 63,
Department of Pulmonary medicine,
All India Institute of Medical Sciences Rajkot
Village khandheri,
Tehsil-Paddhari,
District- Rajkot Room no 63,
Department of Pulmonary medicine,
All India Institute of Medical Sciences Rajkot
Village khandheri,
Tehsil-Paddhari,
District- Rajkot Rajkot GUJARAT 360110 India |
| Phone |
8169451380 |
| Fax |
|
| Email |
dkunal@live.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Heyma krishna Manoharan |
| Designation |
senior resident |
| Affiliation |
AIIMS Rajkot, Gujarat |
| Address |
Room no 63,
Department of Pulmonary medicine,
All India Institute of Medical Sciences Rajkot
Village khandheri,
Tehsil-Paddhari,
District- Rajkot Room no 63,
Department of Pulmonary medicine,
All India Institute of Medical Sciences Rajkot
Village khandheri,
Tehsil-Paddhari,
District- Rajkot Rajkot GUJARAT 360110 India |
| Phone |
9131875109 |
| Fax |
|
| Email |
heymakrishna1993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.HEYMA KRISHNA MANOHARAN Department of Pulmonary Medicine, Room No 63,AIIMS Rajkot,village Khandheri, Tehsil-Paddhari,District Rajkot, State-Gujarat, Country-India
Pincode-360110 |
|
|
Primary Sponsor
|
| Name |
HEYMA KRISHNA MANOHARAN |
| Address |
Room no 63,
Department of Pulmonary medicine,
All India Institute of Medical Sciences Rajkot
Village khandheri,
Tehsil-Paddhari,
District- Rajkot |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Heyma Krishna Manoharan |
AIIMS RAJKOT |
Room no 63
Department of Pulmonary medicine,AIIMS Rajkot, village khandheri, Tahsi-Paddhari, District Rajkot 360110 Rajkot GUJARAT |
9131875109
heymakrishna1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES, Rajkot, Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J849||Interstitial pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Cases:
Already diagnosed cases of Interstitial lung disease.
Patients providing prior written informed consent
Controls:
Healthy adults above 18 years of age without symptoms of any
respiratory disease like shortness of breath, cough, expectoration, wheezing, pleuritic chest pain and who are not a known case of any
respiratory disease. |
|
| ExclusionCriteria |
| Details |
1. Patients with concomitant respiratory diseases that could interfere with the results (malignancies, heart failure, emphysema, chest wall deformity, neuromuscular diseases, etc.)
2. Patients requiring oxygen at rest
3. Those not able to perform Forced Oscillometry, Spirometry,Lung volume estimation by Body Plethysmography, six minute walk test |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare reactance at 5 Hz (X5) determined by Forced
oscillometry technique between patients with ILD and healthy
individuals. |
At baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1.All newly diagnosed patients of Interstitial lung disease satisfying the inclusion criteria will be enrolled in the study after obtaining written informed consent. 2. Healthy individuals from community will be enrolled in the study after obtaining written informed consent. 3. Demographic details, and anthropometric data of cases with ILD and healthy individuals will be recorded on a predesigned proforma. 4. Clinical data, Forced Vital Capacity from Spirometry, Total lung capacity from body plethysmography and six-minute walk distance from six minute walk test of cases with ILD will be noted. 5.Enrolled participants will undergo Forced oscillometry according to the current European Respiratory Society guidelines.5 Forced Oscillometry device will be preformed using Tremoflo C100 airway oscillometry system, Thorasys,Montreal,Quebec,Canada,in accordance with the recent ERS guidelines. I. After explaining the technique, the participant will be allowed to breathe normally into the system. II. A minimum of three tests, each of 30 s duration, will be performed for each participant. III. Participants will be seated comfortably throughout, holding their heads in a neutral position and wear nose clips. IV. The participant will be asked to place their hands firmly on their cheeks to minimize the shunt effect of the upper airways. V. Participants will be instructed to keep their mouth tightly sealed around the mouthpiece and to keep their tongue low in the mouth by tucking it under the mouthpiece. VI. They will also be asked to avoid swallowing or talking.. Participants will be encouraged quietly throughout each test, to reassure them and to ensure as much freedom from technical errors as possible. 6. X5 inspiratory and expiratory reactance, resonant frequency, reactance area will be measured. |