| CTRI Number |
CTRI/2026/02/104470 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Ultrasound Assessment of Inferior Vena Cava Collapsibility Index to Predict Intraoperative Hypotension in Pregnant Women Undergoing Cesarean Section under Spinal Anesthesia |
|
Scientific Title of Study
|
Preoperative ultrasonographic evaluation ofthe inferior vena cava collapsibility index to predict intraoperative hypotension during spinal anesthesia in pregnant women undergoing caeserean 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 |
DrJyotsna Gogoi |
| Designation |
Post Graduate Trainee Student |
| Affiliation |
Gauhati Medical College |
| Address |
Department of Anaesthesiology and Critical Care Gauhati Medical College and Hospital Bhangagarh Guwahati Kamrup Metro 781032
Kamrup
ASSAM
781032
India |
| Phone |
7086559282 |
| Fax |
|
| Email |
jyotsnagogoi19488@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hiranya Kumar Saharia |
| Designation |
Associate Professor |
| Affiliation |
Gauhati Medical College |
| Address |
Department of Anaesthesiology and Critical Care Gauhati Medical College and Hospital Bhangagarh Guwahati Kamrup Metro 781032
Kamrup
ASSAM
781032
India |
| Phone |
9435087643 |
| Fax |
|
| Email |
sahariahiranya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hiranya Kumar Saharia |
| Designation |
Associate Professor |
| Affiliation |
Gauhati Medical College |
| Address |
Department of Anaesthesiology and Critical Care Gauhati Medical College and Hospital Bhangagarh Guwahati Kamrup Metro 781032
Kamrup
ASSAM
781032
India |
| Phone |
9435087643 |
| Fax |
|
| Email |
sahariahiranya@gmail.com |
|
|
Source of Monetary or Material Support
|
| GAUHATI MEDICAL COLLEGE AND HOSPITAL,BHANGAGARH,GUWAHATI,KAMRUP METRO,PIN:781032 |
|
|
Primary Sponsor
|
| Name |
DR JYOTSNA GOGOI |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,
GAUHATI MEDICAL COLLEGE AND HOSPITAL,BHANGAGARH,GUWAHATI,KAMRUP METRO-781032 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| DrJyotsna Gogoi |
GAUHATI MEDICAL COLLEGE AND HOSPITAL |
Department of Anaesthesiology and Critical Care Gauhati Medical College and Hospital Bhangagarh Guwahati Kamrup Metro 781032
Kamrup
ASSAM |
07086559282
jyotsnagogoi19488@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE,GAUHATI MEDICAL COLLEGE AND HOSPITAL,GUWAHATI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women between 21-35
Elective LSCS
ASA Grade ii |
|
| ExclusionCriteria |
| Details |
Uncontrolled systemic comorbidities(cardiovascular,respiratory,renal)
Patient in whom massive intraoperative loss is present(Placenta Previa,Placenta Accereta)
Eclampsia
Cases refuse to give consent
Patient who recived preload of iv fluid |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the predictive values of inferior vena cava collapsibility index in identifying post spinal hypotension |
IN EVERY 3MINUTE TO 15 MINUTE AFTER SPINAL ANAESTHESIA |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/03/2026 |
| 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="0"
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
|
Hypotension is the common complication of spinal anaesthesia. Hypotension during spinal anaesthesia is mainly due to lower preload, resulting from the gravid uterus compressing the inferior vena cava (IVC) and decrease in systemic vascular resistance followed by vascular dilation following spinal anaesthesia. USG has been used in the evaluation of vascular volume status as a non-invasive technique that can be display blood flow morphology, measurement evaluate the compression of IVC and volume status in full term pregnant women. The variation of internal diameter of the IVC is associated with the respiratory phase. During inspiration negative intrathoracic pressure increases the venous flow to the heart and reduce IVC diameter to minimum. In expiration positive intrathoracic pressure decrease the venous return and maximize the IVC diameter at end expiration. This has been defined as inferior vena cava collapse index. 1.Singh Y, Anand RK, Gupta S, Chowdhury SR, Maitra S, Baidya DK, et al. Role of IVC collapsibility index to predict post spinal hypotension in pregnant women undergoing caesarean section. An observational trial.Saudi Janaesth.2019;13(4):312–7.doi: 10.4103/sja.SJA_27_19. [PMC free article] [PubMed] [CrossRef] [Google Scholar] 2. Sklebar I, Bujas T, Habek D. Spinal Anaesthesia-Induced Hypotension in Obstetrics: Prevention and Therapy. Acta Clin Croat 2019;58(Suppl 1):90–5.doi: 10.20471/acc.2019.58.s1.13. [PMC free article] [PubMed] [CrossRef] [Google Scholar] 3. Rana S, Verma V, Bhandari S, Sharma S, Koundal V, Chaudhary SK. Point-of-care ultrasound in the airway assessment: A correlation of ultrasonography-guided parameters to the Cormack-Lehane Classification. Saudi JAnaesth.2018;12(2):292–6. doi: 10.4103/sja.SJA_540_17. [PMCfree article] [PubMed] [CrossRef] [Google Scholar] 4. Air apetian N, Maizel J, Alyamani O, Mahjoub Y, Lorne E, Levrard M, et al. Does inferior vena cava respiratory variability predict fluid responsiveness in spontaneously breathing patients? 2015;19:400.doi: 10.1186/s13054-015-1100-9. [PMC free article] [PubMed] [CrossRef] [Google Scholar] 5. Karacabey S, Sanri E, Guneysel O. A Non-invasive Method for Assessment of Intravascular Fluid Status: Inferior Vena Cava Diameters and Collapsibility Index.Pak JMed Sci.2016;32(4):836–40. doi: 10.12669/pjms.324.10290. [PMC free article] [PubMed][CrossRef] [Google Scholar] 6. Elbadry AA, Ahmed ED, Motaz AAS.Pre-operative ultrasonographicevaluation of the internal jugular vein collapsibility index and inferior vena cava collapsibility index to predict post spinal Hypotension in pregnant women undergoing caesarean section.Anesth pain med.2022;12(1).doi:10.5812/aapm.121648 7. Panchal PA, Mehta PH,Mehta KH. To study the correlation between preoperative inferior Vena Cava Diameter and Intraoperative Hypotension during spinal Anaesthsia in in Caesarean Section.Indian journal of applied-basic medical science.2021;23(A).doi:10.48165/ ijabms.2021.23104 8. Zhang J, Critchley LA. Inferior Vena Cava Ultrasonography before General Anesthesia Can Predict Hypotension after Induction. Anaesthesiology.2016;124(3):580–9. doi:10.1097/ALN.0000000000001002.[PubMed] [CrossRef][Google Scholar] 9.Airapetian N, Maizel J, Alyamani O, Mahjoub Y, Lorne E, Levrard M, et al. Does inferior vena cava respiratory variability predict fluid responsiveness in spontaneously breathingpatients? crit Care.2015;19:400. doi: 10.1186/s13054-015-1100-9. [PMC free article] [PubMed] [CrossRef] [Google Scholar] 10.Salma ER,Elkashlan M.Preoperative ultrasonographic evaluation of inferior vena cava collapsibility index and caval aorta index as new predictors for hypotension after induction of spinal anesthesia:A prospective observational study.Eur J Anesthesiol.2019 Apr,36(4):297-302.doi:10.1097/EJA.0000000000000956.Erratum in:Eur J Anaesthesiol.2019 Nov;36(11):888.pmid:30664523 |