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CTRI Number  CTRI/2024/05/066790 [Registered on: 06/05/2024] Trial Registered Prospectively
Last Modified On: 02/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Use of sonographic measurement of subclavian vein diameter to study fall in blood pressure after injecting spinal anaesthetic drug in lower back in pregnant patients undergoing caeserean delivery. 
Scientific Title of Study   Role of subclavian vein collapsibilty index (SCVCI) in predicting post spinal hypotension in pregnant women undergoing caesarean section-A prospective 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  Bhavna Pawar 
Designation  Junior Resident 
Affiliation  Lokmanya Tilak Municipal Medical College, Sion 
Address  Department of Anaesthesiology, Lokmanya Tilak Municipal Medical College, Sion, Mumbai.

Mumbai
MAHARASHTRA
400022
India 
Phone  8552938255  
Fax    
Email  bhavnavbo@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Devendra Thakare 
Designation  Associate Professor 
Affiliation  Lokmanya Tilak Municipal Medical College, Sion 
Address  Department of Anaesthesiology, Lokmanya Tilak Muncipal Medical College, Sion, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9892954998  
Fax    
Email  devendra.thakare@gmail.com  
 
Details of Contact Person
Public Query  
Name  Bhavna Pawar 
Designation  junior resident 
Affiliation  Lokmanya Tilak Municipal Medical College, Sion 
Address  Department of Anaesthesiology, Lokmanya Tilak Municipal Medical College, Sion, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  8552938255  
Fax    
Email  bhavnavbo@gmail.com  
 
Source of Monetary or Material Support  
Lokamanya Tilak Municipal medical College and Hospital, Sion 
 
Primary Sponsor  
Name  Lokmanya Tilak Municipal College and Hospital Sion Mumbai 
Address  Department of Anaesthesiology, Lokmanya Tilak Municipal Medical College, 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 
Bhavna Pawar  Lokmaya Tilak Municipal Medical College and Hospital, SION MUMBAI  Lokmanya Tilak MLunicipal Medical College and Hospital, Sion, Mumbai- 400022
Mumbai
MAHARASHTRA 		 8552938255

bhavnavbo@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 LTMGH   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Female patients 18 to 40 years
2. Full term more than 37 weeks of gestation
3. Singleton pregnancy
4. No fetal distress
5. ASA2 for LSCS under spinal anaesthesia 
 
ExclusionCriteria 
Details  1. Contraindications to spinal anaesthesia
2. More than 42 weeks - prolonged pregnancy
3. Pregnancy induced hypertension, pre-eclampsia
4. Pre existing hypotension subjects with hypotension detected before spinal anaesthesia defined as mean blood pressure less than 60mmhg and or systolic function less than 90mmhg
5. Cardiovascular diseases
6. Placental abnormalities
7. Multiple pregnancy
8. Morbid Obesity with BMI more than 35
9.Fetal abnormalities
10. Parturient refusal 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. SCVCI
2. Post spinal hypotension 		 1. At baseline (measured only one time at 15minutes before spinal anaesthesia)
2. 0minutes, 3minutes, 6 minutes, 9minutes, 12minutes, 15minutes, 18minutes, 21minutes, 24minutes, 27minutes, 30minutes or till delivery of baby. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Total amount of fluid measured in millilitres required to correct post spinal hypotension.
2. Total amount of vasoctive drugs measured in micrograms or milligrams required to correct post spinal hypotension. 		 1. 0 minutes, 15 minutes,30 minutes, 45 minutes,50 minutes
2. 10 minutes, 20 minutes, 30minutes, 40 minutes or till correction of hypotension 
 
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)   13/05/2024 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Will be mailed on request

  6. For how long will this data be available start date provided 16-05-2025 and end date provided 16-05-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   After IEC-HR Permission, all pregnant patients fulfilling Inclusion and exclusion criteria posted for caesarean section using sub arachnoid block will be included in the study. All patients will be explained about the study and a written valid informed consent will be taken. All the basic information about the patient and preoperative evaluation will be done from the patient’s history and case sheets. The ultrasound measurements will be performed with the parturient on the transfer bed in the post-anesthesia care unit or labor ward 15 min before anesthesia. An Ultrasound device with a high frequency linear array probe (L12–5; 5–12 MHz) will be used for the measurement of SCV and SCVCI. The ultrasound examination will be performed with parturient in a supine position. It will be ensured that the SCV measurements will be completed within 10 min. Right SCV diameters will be measured in order to get the best crosssectional picture of the vein, the probe will be positioned beneath the proximal region of the midpoint of the clavicle perpendicular to the long axis of the SCV. The dynamic change in diameter will be recorded over time utilizing the M-mode to locate and quantify the minimum and maximum venous diameter during the breathing cycle once the target vein will be located. The maximum (dSCVmax) and minimum (dSCVmin) cross sectional diameters of the SCV at the end of the expiration and inspiration periods were recorded during the same respiratory cycle. The SCVCI will be calculated using the following formula: SCVCI = (dSCVmax – dSVmin)/dSCVmax × 100% All the ultrasound recordings will be performed by registered anesthesiologists and part to the examination results. The parturient will then be transferred to the operation Theater table. The routine protocol includes standard monitoring with electrocardiography, non-invasive blood pressure, and pulse oximetry will be done continuously. The baseline values of systolic blood pressure (SBP) (mmHg), diastolic blood pressure (mmHg) (DBP), mean blood pressure (MBP) (mmHg), heart rate (beats/min) and pulse oximetry will be measured and recorded. The first two resting blood pressure and HR measurements with the parturient in the supine position will be recorded, and the average value be recorded as baseline blood pressure. A quick infusion of Ringer lactate will be administered according to institutional protocol that is 5 ml/kg once the baseline vital parameters are noted. Subsequently spinal anesthesia will be induced using the Routine protocol for SAB in LSCS. The routine protocol for SAB in LSCS is as follows: After taking all aseptic measures, the skin is infiltrated with 2% lignocaine. A 25G Quincke’s spinal needle is introduced at the L3-L4 or L4-L5 intervertebral space with the patient in the sitting position. After ensuring free flow of cerebrospinal fluid, total volume of 2ml +/- 0.4ml containing 0.5% hyperbaric bupivacaine (heavy) with 10 μg) of preservative-free fentanyl is administered in the subarachnoid space over 20–30s. Patients are immediately positioned supine with a 15° left lateral tilt using a wedge under the buttock. Parturient will be withdrawn from the study if they could still feel the pinprick sensation below the T6 level at the beginning of surgery or failed spinal anesthesia. One of the member of anesthesia team will record HR, systolic blood pressure (SBP), diastolic blood pressure, and mean arterial pressure (MAP) at baseline (5 min after stabilization of patient in the OR), at the time of institution of spinal anesthesia, at every 1 min interval for 10 min, and at 3 min intervals until delivery of baby. Hypotension will be defined as a drop in SAP by > 20% from the baseline value, within 15 min after SA administration or before delivery. Patients who developed hypotension will be administered intravenous fluid (250 mL of crystalloid infusion in 10 min) and a vasopressor agent (6 mg of ephedrine or phenylephrine bolus of 50 μg at 2 min intervals) until a 20% increase in SBP or MBP is observed. and the vasopressor bolus will be administered every time if the parturient presents with hypotension before delivery. Total requirement of fluids and vasopressor dose will be noted. In the meantime, patients will be followed up for possible complications such as nausea, vomiting, allergies, etc., and managed as per standard protocol. Bradycardia will be defined as a HR below 50 beats per minute (bpm). If bradycardia is identified, 0.5 mg of atropine will be administered.

PARAMETERS TO BE NOTED
1. SCVCI.
2. Total volume of spinal drug. (ml)
3. Upper sensory level.
4. Total fluid administered before spinal anaesthesia. (ml)
5. Induction-to-delivery interval (min).
6. Total fluid before delivery of baby or post spinal hypotension
whichever is earlier (ml).
7. Total dose of vasoactive drug administered(mcg/mg).
Statistical Analysis:
Data analysis will include following steps:
• The data will be collected from desired sample population using
standard, pre-validated case record proforma.
• The collected data will be entered using M.S. Excel software.
For the normality check, the Shapiro–Wilk test will be used. The patient
and obstetric characteristics will be presented as mean ± standard
deviation or median (interquartile range), as appropriate, and will be
analyzed by an unpaired Student’s t-test (quantitative data between two
groups), Fisher’s exact probability test, or Pearson’s Chi-Square test
(categorical data), as appropriate.
The SCVCI measured by ultrasound in the supine position, will be
analyzed by multinomial logistic regression analysis to determine if they
are independently associated with the incidence of post-spinal
hypotension. The area under the receiver operating characteristic (ROC)
curves will be used to test the ability of the identified parameters to
predict post-spinal hypotension, and the area under the curve (AUC) will
be calculated. The perioperative hemodynamic parameters will be
assessed by two-way analysis of variance with the Bonferroni post hoc
test. A cut off value for SCVCI variation for the prediction of post spinal
hypotension will be determined using the ROC(Receiver Operator
Characteristic curve) and the relation between the total amount of fluid
administered and SCVCI will be analysed using Pearson’s coefficient
test. The secondary parameters associated with hypotension(like BMI,
Gestational age, Amniotic fluid index[AFI],etc) influencing the
development of hypotension, total dose of vasoactive drugs
administration in case of hypotension, total amount of fluid infused
before delivery etc will be assessed by using logistic regression analysis.
All statistical analyses will be performed using SPSS for Windows,
version 24.0 (SPSS Inc., Chicago, IL, USA). If calculated p-values found
less than 0.05, the difference will be considered as significant.
 
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