| CTRI Number |
CTRI/2023/01/049101 [Registered on: 18/01/2023] Trial Registered Prospectively |
| Last Modified On: |
11/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Diagnostic Analytic |
| Study Design |
Other |
|
Public Title of Study
|
Use of ultrasound in assessing volume of fluid in the chest cavity and determining its nature |
|
Scientific Title of Study
|
Role of ultrasound in qualitative and quantitative assessment of pleural effusion - a diagnostic analytic study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anumeha Singh |
| Designation |
DNB Resident |
| Affiliation |
Max Super Speciality Hospital, Shalimar Bagh, New Delhi |
| Address |
Department of Radio-diagnosis
Max Super Speciality Hospital
FC-50, C and D block,
Shalimar Bagh, New Delhi
North West
DELHI
110088
India |
| Phone |
9868803977 |
| Fax |
|
| Email |
anumeha221291@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anumeha Singh |
| Designation |
DNB Resident |
| Affiliation |
Max Super Speciality Hospital, Shalimar Bagh, New Delhi |
| Address |
Department of Radio-diagnosis
Max Super Speciality Hospital
FC-50, C and D block,
Shalimar Bagh, New Delhi
North West
DELHI
110088
India |
| Phone |
9868803977 |
| Fax |
|
| Email |
anumeha221291@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prerna Garg |
| Designation |
Consultant |
| Affiliation |
Max Super Speciality Hospital, Shalimar Bagh, New Delhi |
| Address |
Department of Radio-diagnosis
Max Super Speciality Hospital
FC-50, C and D block,
Shalimar Bagh, New Delhi
North West
DELHI
110088
India |
| Phone |
9654546636 |
| Fax |
|
| Email |
findprerna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Max Super Speciality Hospital, Shalimar Bagh, New Delhi |
|
|
Primary Sponsor
|
| Name |
Max Super Speciality Hospital, Shalimar Bagh, New Delhi |
| Address |
Max Super Speciality Hospital
FC-50, C and D block, Shalimar Bagh, New Delhi - 110088 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anumeha Singh |
Max Super Speciality Hospital, Shalimar Bagh, New Delhi |
Department of Radio-Diagnosis, Ground Floor, FC-50, C and D block, Shalimar Bagh, New Delhi-110088
North West
DELHI |
9868803977
anumeha221291@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Max Healthcare Ethics Committee, Max Super Speciality Hospital, Saket, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J90||Pleural effusion, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients who are above 18 years of age having pleural effusion on lung USG. 2. All patients whose CT Chest done within 24 hours of the ultrasound. 3.All patients whose pleural fluid biochemical analysis done post thoracocentesis. |
|
| ExclusionCriteria |
| Details |
1. Pregnancy 2. Hemodynamically unstable patients 3. Patients not able to obey breathing instructions 4. Patients on mechanical ventilation 5. Patients with history of trauma 6. Subcutaneous emphysema over the chest
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary: 1. To differentiate transudative and exudative pleural effusion on lung USG based on the presence of a combination of factors including echogenicity, pleural thickening and septations, as compared to pleural fluid analyzed using Light’s criteria.
2. Estimation of volume of pleural effusion on lung USG using the Balik’s Formula (supine)/Goecke Formula (erect) as compared to CT chest volumetry. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To calculate the diagnostic accuracy of pleural internal echoes, thickening and septations in classifying pleural effusion as exudate. |
24 hours |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/01/2023 |
| 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="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to evaluate the diagnostic utility of ultrasonography in differentiating exudative from transudative pleural effusion and estimating its volume. The study will enrol a total of 100 subjects over 15-18 months period attending Departments of Medicine/ICU/Radio-Diagnosis in a Corporate hospital, and having pleural effusion diagnosed on USG. To differentiate transudative and exudative pleural effusion, lung USG will evaluate accuracy of presence of a combination of factors including echogenicity, septations and pleural thickening, as compared to pleural fluid analysed using Light’s criteria. Estimation of volume of pleural effusion on lung USG will use the Balik’s Formula (supine position)/Goecke Formula (erect position) as compared to CT chest volumetry. The diagnostic accuracy of various ultrasonographical features being used to distinguish between exudative and transudative pleural effusion will be calculated. Diagnosis of exudate/ transudate and volumetry on USG will help clinician assess the effusion as a whole without the need for invasive investigations like thoracocentesis. Faster diagnosis provided by USG will help make prompt therapeutic decisions and early institution of treatment. Further, in effusions whose nature is clear on ultrasonography and which do not cause distress to the patient, thoracocentesis can be avoided. However, in patients with respiratory distress and large volumes of effusion, therapeutic thoracocentesis would still be required. |