| 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
|
|
|
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
|
|
|
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 |