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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
Outcome  TimePoints 
   
 
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.
 
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