CTRI Number |
CTRI/2022/03/041019 [Registered on: 11/03/2022] Trial Registered Prospectively |
Last Modified On: |
17/07/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Single Arm Study |
Public Title of Study
|
Ultrasound in palliative care |
Scientific Title of Study
|
Early integration of Point Of Care Ultrasound(POCUS) in Oncopalliative Care |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Shunmuga Priya I C |
Designation |
Junior resident |
Affiliation |
AIIMS, new delhi |
Address |
Room 154
Palliative care unit (PCU)
First floor,
Department of oncoanesthesia and palliative Medicine
IRCH,
AIIMS,new delhi
New Delhi DELHI 110029 India |
Phone |
9597873318 |
Fax |
|
Email |
priyamaanaveeran@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
SACHIDANAND JEE BHARATI |
Designation |
ADDITIONAL PROFESSOR |
Affiliation |
AIIMS, NEW DELHI |
Address |
Room 154
Palliative care unit (PCU)
First floor,
Department of oncoanesthesia and palliative Medicine
IRCH,
AIIMS,new delhi
New Delhi DELHI 110029 India |
Phone |
9968436042 |
Fax |
|
Email |
sachidadr@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Shunmuga Priya I C |
Designation |
Junior resident |
Affiliation |
AIIMS, new delhi |
Address |
Room 154
Palliative care unit (PCU)
First floor,
Department of oncoanesthesia and palliative Medicine
IRCH,
AIIMS,new delhi
New Delhi DELHI 110029 India |
Phone |
9597873318 |
Fax |
|
Email |
priyamaanaveeran@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
AIIMS New Delhi |
Address |
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 2 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr sushma bhatnagar |
AIIMS, new delhi |
dr.Sushma Bhatnagar-H.O.D
Dep of oncoanesthesia and palliative Medicine
Room 154
Palliative care unit (PCU)
first floor
IRCH.
New Delhi DELHI |
9811326453
sushmabhatnagar1@gmail.com |
Dr sushma bhatnagar |
NCI-AIIMS |
hospital block, third floor
palliative care ward
department of oncoanesthesia and palliative medicine Jhajjar HARYANA |
9811326453
sushmabhatnagar1@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH, AIIMS ,NEW DELHI |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: C801||Malignant (primary) neoplasm, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
99.00 Year(s) |
Gender |
Both |
Details |
Primary thoracoabdominopelvic and breast cancer patient of ECOG-PS 0-4 irrespective of disease staging and presenting symptoms requiring palliative care |
|
ExclusionCriteria |
Details |
Patient refusal to participate, admitted for End Of Life Care(EOLC),presence of cognitive impairment, agitation ,dementia |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To assess the role of early integration of POCUS in management of patients with thoracoabdominopelvic and breast cancer admitted in oncopalliative care |
at baseline |
|
Secondary Outcome
|
Outcome |
TimePoints |
To see type of intervention required after POCUS assesment
Role of POCUS assessment in formulating the treatment plan of patient. |
at baseline |
|
Target Sample Size
|
Total Sample Size="300" Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "320"
Final Enrollment numbers achieved (India)="320" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
11/03/2022 |
Date of Study Completion (India) |
08/04/2023 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
08/04/2023 |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
After obtaining institutional ethical clearance and CTRI
registration this study has been conducted over 13 months as a single cantered
study in our tertiary center to assess the role of early integration of POCUS
in abdomino-thoraco-pelvic-breast malignancy patients admitted to our
palliative care ward. When our study population presents to our palliative care
ward with some acute medical condition, POCUS evaluation of the thorax,
abdomen, DVT 2-point test (femoral vein and popliteal vein), ONSD is done for
all patients irrespective of symptoms. The POCUS diagnosis will be correlated
with the physical examination findings by a palliative physician and any new
finding potential to change the management plan is recorded as a positive POCUS
outcome. This examination is done on the same day of admission after the
clinical examination. Out of these 320 examined cases, 91 patients had positive
POCUS outcomes (28%). Also, the early presentation to palliative care since
diagnosis as seen with the highest of 72 patients presenting within 2 months of
diagnosis, increases the responsibility of the palliative physician to
improvise his skill on this easily available and reliable diagnostic tool.
Oncology patients with an increase in survival are seen along with advances in
treatment options, so there is a major cohort of palliative patients whose
acute symptoms are also inadequately evaluated contributing it all blindly to
the incurable nature/ stage of the disease, poor ECOG-PS of the patients. But
this bedside POCUS with its versatile nature is capable to provide a
non-invasive, affordable, time-saving report and helping in the management of
the symptoms to improve the quality of life in these patients. |