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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  
AIIMS,NEW DELHI  
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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