| CTRI Number |
CTRI/2024/04/066152 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
31/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Comparative observational study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of two ultrasound guided measurement indices to predict hypotension after administration of general aneasthesia |
|
Scientific Title of Study
|
Comparison of inferior venacava collapsibility index with internal jugular vein collapsibility index for predicting post induction hypotension in general anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
FATHIMA C K |
| Designation |
Post graduate student |
| Affiliation |
Amrita institute of medical science, Kochi |
| Address |
Department of Anaesthesia and critical care
Amrita institute of medical sciences
Edapally, Kochi
Ernakulam KERALA 682041 India |
| Phone |
9496128839 |
| Fax |
|
| Email |
fathimack111@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sindhu Balakrishnan |
| Designation |
Clinical associate professor |
| Affiliation |
Amrita institute of medical science |
| Address |
Department of Anaesthesia and critical care
Amrita institute of medical sciences
Edapally, Kochi
Ernakulam KERALA 682041 India |
| Phone |
9895148416 |
| Fax |
|
| Email |
sindhuskumar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sindhu Balakrishnan |
| Designation |
Clinical associate professor |
| Affiliation |
Amrita institute of medical science |
| Address |
Department of Anaesthesia and critical care
Amrita institute of medical sciences
Edapally, Kochi
Ernakulam KERALA 682041 India |
| Phone |
9895148416 |
| Fax |
|
| Email |
sindhuskumar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
FATHIMA C K |
| Address |
Department of Anaesthesia and critical care
Amrita institute of medical sciences
Edapally, Kochi |
| Type of Sponsor |
Other [This is a non interventional study no fundings required] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sindhu Balakrishnan |
Department of Anaesthesia and critical care
Amrita institute of medical sciences
Edapally, Kochi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| FATHIMA C K |
Amrita institute of medical sciences |
Tower 6, Floor 1
Department of Anaesthesia and critical care
Amrita institute of medical sciences
Edapally, Kochi Ernakulam KERALA |
9496128839
fathimack111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethical committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K400||Bilateral inguinal hernia, with obstruction, without gangrene, (2) ICD-10 Condition: K400||Bilateral inguinal hernia, with obstruction, without gangrene, (3) ICD-10 Condition: C18||Malignant neoplasm of colon, (4) ICD-10 Condition: H679||Otitis media in diseases classified elsewhere, unspecified ear, (5) ICD-10 Condition: N209||Urinary calculus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1 Age more than 18 years
2 Only GA
3 Elective surgery
4 ASA 1 and 2
5 BMI less than 30 |
|
| ExclusionCriteria |
| Details |
1 Emergency surgery
2 ASA 3 and above
3 Combined general and regional anaesthesia
4 Already having IJV catheter collar bone fracture wound dressing at the site
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We will be able to predict hypotension in patients who are at increased risk and thus prevent all complications related to same |
study yet to start |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| By preventing hypotension we can prevent complications related to that |
study yet to start |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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)
|
01/06/2024 |
| 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="0" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background More than 300 million1 surgeries are performed every year and arterial hypotension is a common occurrence in patients undergoing surgery under general anaesthesia which is associated with unfavourable patient outcome .An arterial blood pressure below the lower limit of autoregulation can lead to ischemia2 of vital organs ie heart , brain and kidney leading to myocardial infarction or injury, stroke and acute kidney injury. These can lead to prolonged hospital stay with increased cost and can lead to mortality. Post induction hypotension(PIH) is defined as hypotension which occurs after induction of anaesthesia or from induction till beginning of surgical incision3 . The incidence of PIH has a range from 10.3% to 66.3% which may be because of the differencecs in criteria used to define hypotension. This post induction hypotension (PIH) is a modifiable factor which has an impact on the clinical outcome of the patient and so it is important that we prevent it at all cost. This may become possible if we are able to correctly predict it before its occurrence. Factors which influence the occurrence of PIH are the volume status of the patient , the drug and dose of the anaesthetic drug used for induction, administration of GA in combination with neuraxial block, lower SBP at the time of induction , elderly patient ,emergency surgery preoperatively volume depleted and diabetes mellitus. IVC collapsibility index (CI) by ultrasound provides a dynamic non invasive point of care estimate of relative intravascular volume. It has been shown to be a safe and non invasive technique to measure fluid responsiveness in ICU 4. IVC CI is predictive of volume responsiveness with a pooled sensitivity of 75% and specificity of 82% in mechanically ventilated patients and a pooled sensitivity of 71% and specificity of 81% in spontaneously breathing patient 5 IVC CI is calculated by the formula [maximum diameter on expiration-(minimum diameter on inspiration/ maximum diameter on expiration]. There are a few studies which have been done to look at IJV diameter , cross sectional area and their collapsibility index by ultrasonography as an indirect means of CVP. Killu et al showed that IJV CI of > 39% had a sensitivity of 87.5% and specificity of 100% in identifying hypovolemia in ICU patients. Purpose To check if the IVCCI or the IJVCI can predict hypotension before it occurs in patients undergoing surgeries under GA |