| CTRI Number |
CTRI/2021/08/035816 [Registered on: 19/08/2021] Trial Registered Prospectively |
| Last Modified On: |
19/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Can pre-operative internal jugular vein measurements predict hypotension after spinal anaesthesia in pregnant women undergoing cesarean section? |
|
Scientific Title of Study
|
Role of Internal jugular vein(IJV) collapsibility index to predict post spinal hypotension in pregnant women undergoing cesarean section, a prospective observational study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pharanitharan N |
| Designation |
Junior resident |
| Affiliation |
AIIMS Raipur |
| Address |
Department of Anaesthesiology,
AIIMS Raipur.
Raipur
CHHATTISGARH
492099
India |
| Phone |
8012820356 |
| Fax |
|
| Email |
pharanitharan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mamta Sinha |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Raipur |
| Address |
Department of Anaesthesiology,
AIIMS Raipur.
Raipur
CHHATTISGARH
492099
India |
| Phone |
9818113061 |
| Fax |
|
| Email |
drmamta12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pharanitharan N |
| Designation |
Junior resident |
| Affiliation |
AIIMS Raipur |
| Address |
Department of Anaesthesiology,
AIIMS Raipur.
Raipur
CHHATTISGARH
492099
India |
| Phone |
8012820356 |
| Fax |
|
| Email |
pharanitharan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS RAIPUR |
| Address |
Department of Anaesthesiology,
AIIMS Raipur. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Mamta Sinha |
AIIMS Raipur |
A block OT complex, Department of Anaesthesiology,
AIIMS Raipur
Raipur
CHHATTISGARH |
9818113061
drmamta12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Age: 18 – 40 years
2. American Society of Anaesthesiologists Physical Status II
3. Singleton pregnancy
4. Elective cesarean section under spinal anaesthesia
5.Gestational age >37 weeks |
|
| ExclusionCriteria |
| Details |
1.Essential or pregnancy-induced hypertension.
2.Diabetes including gestational diabetes.
3.Heart disease.
4.Abruptio placenta.
5.Placenta previa
6.Premature and Over dated (<36 or >41 weeks gestation) pregnancy.
7.Haemoglobin of less than 7 gm/dl.
8.Hemoglobinopathies.
9.Peripheral vascular disease.
10.Coagulopathies.
11.parturient with baseline heart rate of <50/minutes.
12.Partial spinal block.
13.Fetal condition (IUGR, severe congenital anomalies) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| IJV diameter,IJV collapsibility index, episodes of intra operative hypotension |
IJV diameter and IJV collapsibility index will be measured preoperatively, Blood pressure monitoring (Systolic, diastolic and mean arterial pressures)from spinal anaesthesia every 3 minutes until delivery of the baby.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Body mass index (BMI),
period of fasting, abdominal girth, boluses of vasopressor used,heart rate and SpO2 |
Body mass index (BMI),
period of fasting, abdominal girth will be measured preoperatively. Boluses of vasopressors used, HR, SpO2 and blood pressure monitoring (Systolic, diastolic and mean arterial pressures)from spinal anaesthesia every 3 minutes until delivery of the baby. |
|
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Target Sample Size
|
Total Sample Size="91"
Sample Size from India="91"
Final Enrollment numbers achieved (Total)= "91"
Final Enrollment numbers achieved (India)="91" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/08/2021 |
| Date of Study Completion (India) |
10/11/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Internal jugular vein (IJV) is easier to access and there is limited data and study in the aspect of IJV collapsibility index as a predictor of post spinal hypotension, especially in pregnant women. This study is aimed at evaluation of IJV collapsibility index in assessment of post-spinal hypotension in caesarean section.
Patient fulfilling inclusion criteria will be explained about the procedure and after taking consent ,patient will be included in the study. Baseline hemodynamic parameters will be noted. Patient will be subjected to ultrasonography of the right side of neck using linear probe ,the sonographic measurements of IJV will be assessed using M mode imaging and measurements such as depth of IJV ,relation to carotid artery, maximum diameter (at end of expiration),minimum diameter(at end of inspiration),collapsibility index will be measured. The anaesthesiologist performing ultrasonography will not be involved in intraoperative monitoring. Patient will recieve spinal anaesthesia and sensory level of T6 is targeted .And parameter such blood pressure (SBP,DBP,MAP),HR,RR,SpO2 will be noted every 3 minutes until delivery of the baby. The fall of MAP by 20% from baseline or <65 mmHg will be considered as hypotension. Hypotension will be treated with 6mg of mephentermine or 25mcg of phenylephrine intravenously. The study will finish with delivery of the baby& cord clamping. Data collection will be stopped and number of doses of vasopressor used to counteract hypotension will be noted. |