| CTRI Number |
CTRI/2018/03/012485 [Registered on: 12/03/2018] Trial Registered Prospectively |
| Last Modified On: |
27/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
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Type of Study
|
Observational |
| Study Design |
Single Arm Study |
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Public Title of Study
|
A New Study For Assessment Of Role Of Change In Diameter Of A Large Vein In Abdomen And Peak Velocity Of Blood In A Major Artery In Neck With Respiration,Interpreted With Ultrasound, In Prediction Of Post Spinal Anaesthesia Hypotension In Spontaneously Breathing Patients |
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Scientific Title of Study
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Assessment Of Role Of Inferior Vena Cava Collapsibility Index (IVCCI) And Variations In Carotid Artery Peak Systolic Velocity (CAPV)In Prediction Of Post Spinal Anesthesia Hypotension In Spontaneously Breathing Patients: A Pilot Study |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUMIT ROY CHOWDHURY |
| Designation |
Junior Resident |
| Affiliation |
AIIMS NEW DELHI |
| Address |
All India Institute of Medical Sciences, Department of Anaesthesiology, Pain Medicine and Critical Care, Main building, Fifth Floor, Room 5011, Ansarinagar
AIIMS,Ansarinagar,New Delhi-110029
South
DELHI
110029
India |
| Phone |
9874621132 |
| Fax |
|
| Email |
sumitroychowdhury94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rahul Kumar Anand |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
All India Institute of Medical Sciences, Department of Anaesthesiology, Pain Medicine and Critical Care, Main building, Fifth Floor, Room 5011,Ansarinagar
AIIMS,Ansarinagar,New Delhi-110029
South
DELHI
110029
India |
| Phone |
9013082271 |
| Fax |
|
| Email |
rahulanand00@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SUMIT ROY CHOWDHURY |
| Designation |
Junior Resident |
| Affiliation |
AIIMS NEW DELHI |
| Address |
All India Institute of Medical Sciences, Department of Anaesthesiology, Pain Medicine and Critical Care, Main building, Fifth Floor, Room 5011, Ansarinagar
AIIMS,Ansarinagar,New Delhi-110029
South
DELHI
110029
India |
| Phone |
9874621132 |
| Fax |
|
| Email |
sumitroychowdhury94@gmail.com |
|
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Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi, Ansarinagar.Pin-110029 |
|
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Primary Sponsor
|
| Name |
All India Institute of Medical Sciences New Delhi |
| Address |
AIIMS,Ansarinagar,New Delhi, 110029 |
| Type of Sponsor |
Research institution |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SUMIT ROY CHOWDHURY |
AIll India Institute of Medical Sciences, New Delhi |
Department of Anaesthesiology, Pain Medicine and Critical Care, Main building, Fifth Floor, Room 5011
South
DELHI |
9874621132
sumitroychowdhury94@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee For Post Graduate Research, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029 |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C402||Malignant neoplasm of long bones of lower limb, (2) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
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Intervention / Comparator Agent
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of ASA physical status I and II posted for elective lower abdominal surgeries to be done only under spinal anaesthesia.
2.Aged between 18-65 years. |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Patients undergoing Caesarean section
3.Known hypertensive patientsÂ
4.History of chronic alcoholismÂ
5.History or signs of Pulmonary hypertension
6.Coagulopathy
7.Local site infections
8.Inability to obtain good quality image
9.Presence of ascites
10.Patients with cardiac lesions like-tricuspid regurgitation(TR), Aortic Stenosis(AS).
11.Common carotid artery plaque. |
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Method of Generating Random Sequence
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Method of Concealment
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Blinding/Masking
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Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the correlation between IVCCI and post spinal anaesthesia hypotension.Â
2. To assess the correlation between respiratory variations of CAPV and post spinal anaesthesia hypotension. |
10 minutes |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the correlation between IVCCI and post spinal anaesthesia hypotension.Â
2. To assess the correlation between respiratory variations of CAPV and post spinal anaesthesia hypotension.
I dont have any secondary objectives, only have primary objectives. |
10 minutes |
|
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Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/03/2018 |
| Date of Study Completion (India) |
20/12/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
|
Hypotension is a common side effect of spinal anesthesia. There is no gold standard test to predict poat spinal hypotension.Isg guided assessment of IVC Collapsibility Index (IVCCI) and doppler guided measurement of variations of Carotid artery peak systolic velocity (CAPV) are two widely used predictors of fluid responsivenss. Fluid responsivenss and hypotension are closely related. We therefore want to do a pilot study to assess if there is any correlation of of IVCCI and CAPV with post spinal hypotension. As there’s no available to best of our knowledge, we will do a pilot study. |