| CTRI Number |
CTRI/2025/08/092180 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
RETROSPECTIV OBSERVATIONAL STUDY |
| Study Design |
Other |
|
Public Title of Study
|
To compare the measured parameters of spirometry and Forced oscillation technique in COPD patients |
|
Scientific Title of Study
|
To study correlation of spirometry and forced oscillometry in patients of chronic obstructive airway disease- retrospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Heyma krishna Manoharan |
| Designation |
SENIOR RESIDENT |
| Affiliation |
Senior resident |
| Address |
Room No 63, Department of Pulmonary Medicine,All India Institute Of Medical Sciences (AIIMS),
Khanderi, Para Pipaliya, Rajkot, Gujarat, INDIA, 360006
Rajkot
GUJARAT
360006
India |
| Phone |
9131875109 |
| Fax |
|
| Email |
heymakrishna1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Heyma krishna Manoharan |
| Designation |
SENIOR RESIDENT |
| Affiliation |
AIIMS RAJKOT |
| Address |
Room No 63, Department of Pulmonary medicine,All India Institute Of Medical Sciences (AIIMS),
Khanderi, Para Pipaliya, Rajkot, Gujarat, INDIA, 360006
GUJARAT
360006
India |
| Phone |
9131875109 |
| Fax |
|
| Email |
heymakrishna1993@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Heyma krishna Manoharan |
| Designation |
SENIOR RESIDENT |
| Affiliation |
AIIMS RAJKOT |
| Address |
Room No 63, Department of Pulmonary Medicine,All India Institute Of Medical Sciences (AIIMS),Khanderi, Para Pipaliya, Rajkot, Gujarat, INDIA, 360006
GUJARAT
360006
India |
| Phone |
9131875109 |
| Fax |
|
| Email |
heymakrishna1993@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DRHEYMA KRISHNA MANOHARAN |
| Address |
All India Institute Of Medical Sciences (AIIMS),
Khanderi, Para Pipaliya, Rajkot, Gujarat, INDIA, 360006 |
| 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 |
All India Institute Of Medical Sciences (AIIMS), Rajkot |
Room no 63, Department of pulmonary medicine.
Rajkot
GUJARAT |
9131875109
heymakrishna1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Rajkot, Gujarat Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J984||Other disorders of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient of COPD who have undergone spirometry and forced oscillometry will be selected for inclusion in the study after obtaining written informed consent. |
|
| ExclusionCriteria |
| Details |
Those patient who do not give consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To study the correlation of FEVI obtained by spirometry with R5, R5-R20, Ax, X5, Fres obtained by forced Oscillometry.
2.To study the correlation of FEF25-75 obtained by spirometry with R5, R5-R20, Ax, Fres, X5 obtained by forced oscillometry.
3.To study the correlation of postbronchodilator change in FEV1 with R5 and R5-R20.
|
1 To study the correlation of FEVI obtained by spirometry with R5, R5-R20, Ax, X5, Fres obtained by forced Oscillometry.
2.To study the correlation of FEF25-75 obtained by spirometry with R5, R5-R20, Ax, Fres, X5 obtained by forced oscillometry.
3.To study the correlation of postbronchodilator change in FEV1 with R5 and R5-R20.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
30/08/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
I.
Pulmonary department at AIIMS Rajkot started performing spirometry from March 2022.
Forced oscillometry from November 2023. So list of all patients who were
diagnosed with COPD from November 2023 till date will be retreived from the
electronic medical record of the department.
II.
Patient of COPD who have undergone spirometry and forced
oscillometry will be selected for inclusion in the study after obtaining
written informed consent.
III.
Data extracted will include:
1.Demographic data- Age,
Gender, occupation, residence.
2.Smoking status-
Bidi/cigarette, smoking index, packs in year.
3.COPD GOLD stage.
4. Aetiology of COPD.
5.Spirometry parameters
FEV1, FVC. FEV1/FVC, FEF 25-75 pre and post bronchodilator.
6. Forced oscillometry
parameters – R5, R5-R20, Ax, Pre and Post Bronchodilator.
|