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CTRI Number  CTRI/2024/05/068131 [Registered on: 31/05/2024] Trial Registered Prospectively
Last Modified On: 30/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Use of ultrasound to assess fluid status in pregnant patients with high blood pressure undergoing caesarean section  
Scientific Title of Study   Feasibility and utility of Venous Excess Ultrasound Score to assess fluid status postoperatively in patients with severe pre eclampsia and eclampsia following lower segment 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  Dr Bheemambika kuri  
Designation  Junior resident in department of anaesthesiology and critical care 
Affiliation  Vijaynagar institute of medical sciences, Ballari 
Address  Department of anaesthesiology, Vijayanagar institute of medical sciences, cantonment , Ballari

Bellary
KARNATAKA
583104
India 
Phone  9535514434  
Fax    
Email  ambikakuri375@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jyothsna M 
Designation  Professor, Department of anaesthesiology and critical care  
Affiliation  Vijaynagar institute of medical sciences, Ballari 
Address  Department of anaesthesiology, Vijayanagar institute of medical sciences, cantonment , Ballari

Bellary
KARNATAKA
583104
India 
Phone  9900055996  
Fax    
Email  jyothsnabk@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jyothsna M 
Designation  Professor, Department of anaesthesiology and critical care  
Affiliation  Vijaynagar institute of medical sciences, Ballari 
Address  Department of anaesthesiology, Vijayanagar institute of medical sciences, cantonment , Ballari

Bellary
KARNATAKA
583104
India 
Phone  9900055996  
Fax    
Email  jyothsnabk@yahoo.com  
 
Source of Monetary or Material Support  
Vijaynagar institute of medical sciences, Cantonment, Ballari - 583104, Karnataka, India  
 
Primary Sponsor  
Name  Vijaynagar institute of medical sciences  
Address  Vijaynagar institute of medical sciences, Cantonment ,Ballari - 583104, Karnataka, India  
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 Bheemambika kuri  Vijayanagar Institute Of Medical Sciences  Room no. 99, Department of obstetrics and gynaecology, Postoperative ward
Bellary
KARNATAKA 
9535514434

ambikakuri375@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vijayanagar institute of medical sciences, Ballari , Institutional ethics committee, VIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O141||Severe pre-eclampsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Pregnant women of age more than 18 years with severe pre eclampsia and eclampsia scheduled for Lower segment cesarean section under general anaesthesia or spinal anaesthesia  
 
ExclusionCriteria 
Details  Patients refusal
History of allergy to drugs,liver disease, renal disease
Right heart dysfunction, Valvular heart diseases
Any contraindications for spinal anaesthesia orgeneral anaesthesia
Any severe systemic disorder
Hemolysis elevated liver enzymes and low platelets syndrome, severe fetal distress, cord prolapse, twin pregnancy,
Morbid obesity (Body mass index more than 40kg/m2) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Feasibility of VExUS and incidence of Postoperative venous congestion  0 hour, 6 hours and 24 hours post operatively 
 
Secondary Outcome  
Outcome  TimePoints 
1.Incidence of pulmonary edema
2.Incidence of hypoxia
3.Need of diuretics for venous decongestion
4.Need for mechanical ventilatory support
5.Incidence of acute Kidney injury

 
0 hour to 24 hours post operatively
0 hour to 24 hours post operatively
0 hour to 24 hours post operatively
0 hour to 24 hours post operatively
0 hour to 24 hours post operatively


 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   25/06/2024 
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="1"
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  
Thorough preoperative evaluation and necessary investigations are carried out and written and informed consents of patients/ patient attenders of age 18 to 40 years females with severe Pre eclampsia and eclampsia scheduled for emergency lower segment cesarean section are taken



VExUS protocol-guided ultrasound scanning shall be performed, postoperatively at 0 hour, 6 hours and approximately 24 hours postoperatively (in High Dependency Unit /Post surgical intensive care unit). Scans will be completed using the curvilinear probe(2-5MHz) Sonosite S2 US machine.



Initially Transthoracic echo will be performed in supine position to rule out right heart dysfunction and other cardiac pathologies. Then IVC will be visualised in the subxiphoid window, but  would elect for midaxillary window if necessary. The IVC diameter will be measured in long axis with special attention taken to observe widest perpendicular diameter. The hepatic, portal, and intrarenal veins will be visualized in the midaxillary window and the posterior axillary window with patient in supine position.  Focused effort would be made to scan the main hepatic, main portal, and interlobar renal veins and not the possible other branches of each respective vessel. To obtain sufficient doppler signals, breath holding would be conducted to stabilize the diaphragm and secure adequate windows. This brief breath holding would be done at various points throughout the respiratory cycle depending on what would elicit the best anatomical views for using doppler. Then pulsatility index of these veins will be calculated. The ultrasonographic examination will be done by the Post graduate under the supervision of the guide. The Post graduate would have performed at least 50 examinations (50 patients) under the guidance of the experienced guide in the pilot testing before actual recruitment of patients.



Based on the findings of the above mentioned veins VExUS grading will be carried out as follows:




Grade 0 : No Venous congestion, IVC < 2cm

Grade 1 : mild Venous congestion, IVC > or = to 2cms + any combination of normal or mildly abnormal waveforms

Grade 2 : moderate Venous congestion, IVC > or = 2cms + at least one severely abnormal waveform

Grade 3 : severe Venous congestion, IVC > or = to 2 cms + 2 or more severely abnormal waveforms




Data management and statistics:

The data will be entered in MS Excel sheet cleaned and the averages/ means proportions /diameters/ pulsetility index percentages/ gradings are noted. The continuous variables related to the IVC diameters, waveforms and pulsatility index of the hepatic vein, portal vein and intrarenal veins at different intervals of 0 hour, 6 hours and 24 hours post operatively are expressed in centimetres and percentages. Grading according to the VExUS grading protocol will be expressed. And the other data related to the patients characteristics such as age, address ,diagnosis ,basal vitals and the vitals trends intraoperatively and the other data related to the patient will be entered as necessary. The data will be checked for uniformity of distribution
 
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