| CTRI Number |
CTRI/2021/04/032932 [Registered on: 19/04/2021] Trial Registered Prospectively |
| Last Modified On: |
14/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
This study is to predict low bloodpressure changes after giving general anaesthesia by measuring and comparing diameters of greater veins. |
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Scientific Title of Study
|
“Prospective Observational Study To Compare Subclavian Vein/Infraclavicular Axillary Vein Collapsibility Index With Inferior Venacava Collapsibility Index (During Spontaneous Breathing Or Deep Inspiration) In Predicting Hypotension After Induction Of General Anaesthesia.†|
| 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 |
KOLA HARI POORNIMA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE,KAHER |
| Address |
DEPARTMENT OF ANAESTHESIA,
2ND FLOOR,KLE DR.PRABHAKAR KORE HOSPITAL AND MEDICAL RESEARCH,JNMC CAMPUS ,BELAGAVI.
BELAGAVI
DEPARTMENT OF ANAESTHESIA,
2ND FLOOR,KLE DR.PRABHAKAR KORE HOSPITAL AND MEDICAL RESEARCH,JNMC CAMPUS ,BELAGAVI.
Belgaum
KARNATAKA
590010
India |
| Phone |
8106696541 |
| Fax |
|
| Email |
poornimahari89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrManjunath CPatil |
| Designation |
PROFESSOR |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE,KAHER |
| Address |
DEPARTMENT OF ANAESTHESIA,
2ND FLOOR,KLE DR.PRABHAKAR KORE HOSPITAL AND MEDICAL RESEARCH,
JNMC,NEHRUNAGAR,
BELAGAVI.
DEPARTMENT OF ANAESTHESIA,
2ND FLOOR,KLE DR.PRABHAKAR KORE HOSPITAL AND MEDICAL RESEARCH,JNMC CAMPUS ,BELAGAVI.
Belgaum
KARNATAKA
590010
India |
| Phone |
9743110637 |
| Fax |
|
| Email |
mcpatil52@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KOLA HARI POORNIMA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE,KAHER |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,2nd floor,KLE DR.PRABHAKAR KORE CHARITABLE HOSPITAL AND MEDICAL RESEARCH,JNMC campus,Nehru nagar,Belgaum.
DEPARTMENT OF ANAESTHESIOLOGY,2nd floor,KLE DR.PRABHAKAR KORE CHARITABLE HOSPITAL AND MEDICAL RESEARCH,JNMC campus,Nehru nagar,Belgaum.
Belgaum
KARNATAKA
590010
India |
| Phone |
8106696541 |
| Fax |
|
| Email |
poornimahari89@gmail.com |
|
|
Source of Monetary or Material Support
|
| SELF and KLE PRABAKHAR KORE HOSPITAL AND RESEARCH CENTRE |
|
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Primary Sponsor
|
| Name |
at KLEs Dr Prabhakar Kore charitable Hospital and Medical Research Centre |
| Address |
JNMC,KAHER,
NEHRU NAGAR,
BELAGAVI |
| Type of Sponsor |
Research institution and hospital |
|
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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 |
| DrKOLA HARI POORNIMA |
KLES DR. PRABHAKAR KORE HOSPITAL AND MEDICAL RESEARCH CENTRE |
Department of anaesthesiology,2nd floor,KLE DR.PRABHAKAR KORE HOSPITAL AND. EDICAL RESEARCH,JNMC CAMPUS,NEHRU NAGAR,BELGAUM
Belgaum
KARNATAKA |
8106696541
poornimahari89@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE ON HUMAN SUBJECTS RESEARCH |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K37||Unspecified appendicitis, |
|
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Intervention / Comparator Agent
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I and II.
Age between 18 to 60 years.
Patients undergoing elective surgeries under general anaesthesia.
Provides Consent
|
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| ExclusionCriteria |
| Details |
Patient undergoing emergency surgery.
Patient who are unable to give consent.
Patients requiring rapid sequence intubation.
Patient experiencing prolonged airway instrumentation because of difficult intubation.
Patients on vasopressors to maintain mean arterial blood pressure >65mmHg.
Presence of major peripheral vascular diseases
Patients with increased intra abdominal pressure.
Patients with implanted pacemaker/ cardioverter.
Patient with multiple risk factors
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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 |
| To compare the subclavian vein/infraclavicular axillary vein collapsibility index with Inferior venacava collapsibility index (during spontaneous breathing or deep inspiration) in predicting hypotension after induction of general anaesthesia. |
induction,2mins,4mins,6mins,8mins,incision. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To predict hypotension |
induction,2mins,4mins,6mins,8mins,incision. |
|
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Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
26/04/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
This study will be helpful in identifying the best method to predict hypotension after inducing the general anaesthesia using ultrasonographic evaluation of collapsibility of major veins,viz.. subclavian vein,inferior venacava. |