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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  
NIL 
 
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  
Status 
Not Applicable 
 
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 patientIVC 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

 
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