| CTRI Number |
CTRI/2020/09/028051 [Registered on: 25/09/2020] Trial Registered Prospectively |
| Last Modified On: |
24/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation between Inferior vena cava and fall in blood pressure after anaesthesia |
|
Scientific Title of Study
|
Assessment of validity of Preoperative inferior vena cava collapsibility index in predicting post induction hypotension- a cross sectional prevalence study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Annie Lalliankimi Fanai |
| Designation |
Junior resident |
| Affiliation |
Indira Gandhi Medical College |
| Address |
Department of Anaesthesiology and critical care IGMC Shimla 171001
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
|
| Fax |
|
| Email |
annie.teboihi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Jyoti Pathania |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Medical College |
| Address |
Department of Anaesthesiology and critical care IGMC Shimla 171001
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418120659 |
| Fax |
|
| Email |
pathaniajyoti7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Annie Lalliankimi Fanai |
| Designation |
Junior resident |
| Affiliation |
Indira Gandhi Medical College |
| Address |
Department of Anaesthesiology and critical care IGMC Shimla 171001
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
|
| Fax |
|
| Email |
annie.teboihi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and critical care IGMC Shimla |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical Care |
| Address |
Indira Gandhi Medical College Shimla Himachal Pradesh 171001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Anaesthesiology and critical care |
IGMC Shimla |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Annie Lalliankimi Fanai |
Department Of Anaesthesiology and Critical Care |
IGMC Shimla
Shimla
HIMACHAL PRADESH |
7005664080
annie.teboihi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K80||Cholelithiasis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 patients between the age of 40-60 years weighing 50-80 kg undergoing elective surgery under general anaesthesia with accessible epigastric region will be included in the study |
|
| ExclusionCriteria |
| Details |
Asa more than or equal to 3
Dyspnoea
Uncontrolled hypertension
Decompensated heart failure
Significant valvular disease
Significant carotid stenosis
Ejection fraction < 40%
Respiratory distress
Increased intra abdominal pressure
Anticipated difficult airway
Mental incompetence
Pheochromocytoma
Ivc non visualuzed |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out whether the inferior vena cava has any role in predicting the fall of blood pressure in patients after giving them anaesthesia |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To measure the inferior Vena cava collapsibity index pre-operatively
To measure the hemodynamic changes post induction and see its correlation with the inferior vena collapsibility index |
Measurement of hemodynamic changes every 1 minute post induction upto 4 minutes and then every 2 minutes upto 10 minutes post intubation |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/10/2020 |
| 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 |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To Assess the validity of Preoperative Inferior Vena Cava Collapsibility Index in predicting Post Induction hypotension by comparing the hemodynamic changes in relation to the inferior vena cava collapsibility index |