FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/11/060138 [Registered on: 22/11/2023] Trial Registered Prospectively
Last Modified On: 17/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Comparison of common carotid artery corrected flow time and inferior vena cava collapsibility index measured by ultrasonography for prediction of hypotension after general anesthesia in adult patients  
Scientific Title of Study   Comparison of common carotid artery corrected flow time and inferior vena cava collapsibility index measured by ultrasonography for prediction of hypotension after general anesthesia in adult patients undergoing elective gastro-intestinal surgery 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chavan santosh hariba  
Designation  Junior resident  
Affiliation  Lokmanya Tilak Municipal General Hospital and Medical College 
Address  4th floor , department of Anesthesiology,College building ,Lokmanya tilak municipal medical College,sion,Mumbai 400022 Mumbai MAHARASHTRA 400022 India

Mumbai
MAHARASHTRA
400022
India 
Phone  7020117982  
Fax    
Email  dr.santosh1111@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Preeti SRustagi 
Designation  Associate Professor LTMMC AND GH 
Affiliation  Lokmanya Tilak Municipal General Hospital and Medical College 
Address  4th floor , department of Anesthesiology,College building ,Lokmanya tilak municipal medical College,sion,Mumbai 400022 Mumbai MAHARASHTRA 400022 India

Mumbai
MAHARASHTRA
400022
India 
Phone  9769215359  
Fax    
Email  drpreetirustagi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Chavan santosh hariba 
Designation  Junior resident 
Affiliation  Lokmanya Tilak Municipal General Hospital and Medical College 
Address  4th floor , department of Anesthesiology,College building ,Lokmanya tilak municipal medical College,sion,Mumbai 400022 Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  7020117982  
Fax    
Email  dr.santosh1111@gmail.com  
 
Source of Monetary or Material Support  
Lokmanya Tilak Municipal Medical College General Hospital Sion Mumbai  
 
Primary Sponsor  
Name  Lokmanya Tilak Municipal Medical College and General Hospital Sion Mumbai  
Address  Lokmanya Tilak Municipal Medical College and General Hospital Sion Mumbai  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr santosh hariba Chavan  Lokmanya Tilak Municipal Medical College and General Hospital Sion Mumbai   Fourth floor department of Anesthesiology College building
Mumbai
MAHARASHTRA 
7020117982

dr.santosh1111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee human research lokmanya tilak municipal medical College and general hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K928||Other specified diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  All patients undergoing elective gastrointestinal surgery with General
anesthesia age 18 - 45 years.
1)American Society of Anesthesiologists – Physical status (ASA-PS:I, II,III)
2)Patient willing to participate in our study. 
 
ExclusionCriteria 
Details  Patient with peripheral artery disease.
1)Patients with known carotid artery stenosis.
2) Pregnant patients.
3) Patients with cardiac comorbidity and arrhythmia.
4)Patients with history of neck surgery/neck trauma
5)Patients with respiratory distress.
6)Patients with increased intra-abdominal pressure. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To compare the predictive value of corrected common carotid artery flow time and IVC collapsibility index for hypotension after general anesthesia
time and inferior vena cava collapsibility index for hypotension after general
anaesthesia in patients undergoing surgery 
2,4,6,10.15,20,25, 30 min after induction of anaesthesia  
 
Secondary Outcome  
Outcome  TimePoints 
To measure common carotid cFT and assess its specificity, sensitivity
and predictive value for hypotension after general anesthesia
2. To measure and assess IVC collapsibility index ultrasonographicalyand
assess its specificity, sensitivity and predictive value for hypotension after
general anesthesia
 
2,4,6,10.15,20,25, 30 min after induction of anaesthesia  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/12/2023 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.santosh1111@gmail.com].

  6. For how long will this data be available start date provided 01-05-2025 and end date provided 01-08-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Hypotension is common after induction of general anesthesia¹, and
intraoperative hypotension is associated with postoperative end-organ injury2,3.
The incidence of hypotension after induction of general anaesthesia is variable
and depends on the patients characteristics, volume status of the patient, and the
induction agent used4,.Immediately after induction of general anaesthesia,
patients are at particular risk of hypotension because of the cardiovascular
depressant and vasodilatory effects of induction agents, as well as a lack of
surgical stimulation. Furthermore, patients undergoing elective gastro-intestinal
surgery may be hypovolemic for multiple reasons, such as preoperative fasting,
bowel preparation, etc. Hypovolemia increases the risk of hypotension3,4Despite
worldwide improvement in preoperative optimization and changing practices
promoting the avoidance of unnecessary fasting and bowel preparation, post-
anaesthesia induction hypotension is still a concern.
Latent hypovolemia where there is a decrease in circulating blood volume
without obvious hemodynamic changes and/or organ dysfunction increases the
risk of the development of hypoperfusion in response to external impacts such
as anaesthesia and surgery5
.Preoperative assessment of intravascular volume
statusand identification of latent hypovolemia can help clinicians to ensure
patient safety and a chance to implement proper fluid replacement before
inducing general anaesthesia.
A number of dynamic parameters that assess volume status have been
recommended recently to guide perioperative fluid therapy6 In addition Point of
care ultrasound assessment of major vessels is being increasingly used by
clinicians to assess intravascular volume status.7
Ultrasound measurements of
inferior vena cava (IVC) diameter with respiration and IVC collapsibility index (CI), have been recommended as rapid non-invasive methods for estimating
volume status and to predict hypotension after anaesthesia8,9
However, an assessment of the IVC has several limitations, such as it
may be difficult to obtain IVC measurements in patients with distended
abdomen and it may be of limited utility when there are excessive respiratory
efforts
10
.
Carotid artery Doppler measurements have several advantages, as it is
non-invasive, and because the carotid artery is a superficial artery, it is
technically easy to obtain measurements.Corrected Flow Time (cFT) for
carotid artery is the carotid systole time, with heart rate correction
applied.11It is reported to correlate with intravascular volume status.
12The
common carotid artery corrected flow time(cFT) is not affected by respiratory
efforts; hence, it also can be used as a marker of volume responsiveness in
spontaneously breathing patients.13 .The cFT measured in the common carotid
artery has also been reported as predictor of hypotension after induction of
general anaesthesia14
This study aims to compare Common carotid
arterycFT&IVCcollapsibility index for predicting post -induction hypotension
in adult patients undergoing elective gastro-intestinal surgery.
 
Close