| CTRI Number |
CTRI/2023/10/058810 [Registered on: 18/10/2023] Trial Registered Prospectively |
| Last Modified On: |
17/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of inferior vena cava blood vessel collapsibility using ultrasound before surgery in predicting the incidence of low blood pressure in patients undergoing general anaesthesia |
|
Scientific Title of Study
|
Preoperative ultrasonographic evaluation of inferior venacava collapsibilty as a predictor for hypotension associated with general anaesthesia: An Observational study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shantha |
| Designation |
Junior Resident |
| Affiliation |
Dr BR AMBEDKAR MEDICAL COLLEGE HOSPITAL |
| Address |
1st floor, OT complex block, DR B R Ambedkar medical college and hospital,Kadugondanahalli
Bengaluru-560045
Girls hostel,
DR B R Ambedkar medical college and hospital,Kadugondanahalli
Bengaluru-560045
Bangalore
KARNATAKA
560045
India |
| Phone |
6360119064 |
| Fax |
|
| Email |
poojarishanta1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Salim Iqbal |
| Designation |
Professor |
| Affiliation |
Dr B R Ambedkar Medical College Hospital |
| Address |
Senior staff room, 1st floor, OT complex block, DR B R Ambedkar medical college and hospital, Kadugondanahalli
Bengaluru-560045
Bangalore
KARNATAKA
560045
India |
| Phone |
9964651079 |
| Fax |
|
| Email |
drsalim_iqbal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Salim Iqbal |
| Designation |
Professor |
| Affiliation |
Dr B R Ambedkar Medical College Hospital |
| Address |
Senior staff room, 1st floor, OT complex block, DR B R Ambedkar medical college and hospital, Kadugondanahalli
Bengaluru-560045
Bangalore
KARNATAKA
560045
India |
| Phone |
9964651079 |
| Fax |
|
| Email |
drsalim_iqbal@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Dr B R Ambedkar medical college hospital |
|
|
Primary Sponsor
|
| Name |
Dr B R Ambedkar Medical College Hospital |
| Address |
Dr B R Ambedkar Medical College & Hospital
Kdugondanahalli, Bengaluru- 560045 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shantha |
Dr BR AMBEDKAR MEDICAL COLLEGE HOSPITAL |
1st floor, OT complex block, DR B R Ambedkar medical college and hospital,Kadugondanahalli
Bengaluru-560045
Bangalore
KARNATAKA |
6360119064
poojarishanta1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION ETHICS COMMITTEE, Dr B R Ambedkar medical College and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for elective surgery under general anaesthesia
ASA-PS 1 and 2 patients |
|
| ExclusionCriteria |
| Details |
Hypovolemia
systolic blood pressure <90 mmhg
patients on ACE inhibitors
known case of cardiovascular diseases
implanted pacemakers
elevated pulmonary arterial pressure >40 mmhg
bmi >35 kg/m2 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the IVC collapsibility index for detection of hypotension following general anaesthesia |
at inspiration & expiration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate hemodynamic responses following induction of general anaesthesia |
inspiration & expiration |
|
|
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)
|
27/10/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/10/2023 |
| 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 Yet Recruiting |
| 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
|
Hypotension is common during surgery in patients under anaesthesia and may cause organ under perfusion and ischemia . After induction of general anaesthesia, patients are at particular risk of developing hypotension because of the cardiovascular depressant and vasodilatory effects of anaesthetic agents, as well as lack of surgical stimulation. Furthermore, patients may have preexisting hypovolemia resulting from dehydration and impaired compensatory responses, which increase the risk . Predictors of hypotension after induction of anaesthesia include American Society of Anaesthesiologists physical status (ASA) III and IV, baseline mean arterial pressure lower than 70 mmHg, age more than 50 yr, use of propofol, and high fentanyl dose . Heart rate (HR) variability can predict hypotension and bradycardia after induction of anaesthesia . However, the role of preoperative volume status in the development of hypotension after induction has not been assessed fully. Assessing intravascular volume status is a challenge for clinicians. Traditional static parameters such as central venous pressure have been criticized for invasiveness and lack of accuracy . A number of dynamic parameters that assess volume status have been recommended recently . Ultrasound measurements of inferior vena cava (IVC) diameter with respiration, which include (1) maximum diameter of the IVC (dIVCmax) at the end of expiration during spontaneous respiration and (2) collapsibility index (CI), have been recommended as rapid and noninvasive methods for estimating volume status. These parameters have been proposed as repeatable and easily obtainable parameters by operators with little experience in echocardiography. Therefore, we hypothesize that preoperative dIVCmax and its respiratory variation, that is, CI, could predict the incidence of hypotension after induction of general anaesthesia. The aim of the research is to ultrasonographic evaluation of the inferior vena cava collapsibility for detection of hypotension following general anaesthesia. |