| CTRI Number |
CTRI/2025/10/095970 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to find out if pulse oximeter values from both toes can predict drop in blood pressure during spinal anesthesia for cesarean delivery |
|
Scientific Title of Study
|
Prediction of incidence of spinal hypotension using perfusion index from pulse oximetry of right and left toes in LSCS patients- 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 Aswini Gandhimathi R |
| Designation |
Postgraduate resident- MD Anesthesiology |
| Affiliation |
Chettinad hospital and research institute |
| Address |
Second floor ICU 3,Department of Anesthesiology, Chettinad hospital and research institute, Chettinad health city, rajiv gandhi salai(OMR), Kelambakkam, Tamilnadu 603103
Kancheepuram TAMIL NADU 603103 India |
| Phone |
9487568525 |
| Fax |
|
| Email |
aswinigandhimathi98@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Merlin Shalini Ruth |
| Designation |
Professor |
| Affiliation |
Chettinad hospital and research institute |
| Address |
Second floor ICU -3,Department of Anesthesiology, Chettinad hospital and research institute, Chettinad health city, rajiv gandhi salai(OMR), Kelambakkam, Tamilnadu 603103
Kancheepuram TAMIL NADU 603103 India |
| Phone |
9790983957 |
| Fax |
|
| Email |
merlin5shalini@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Aswini Gandhimathi R |
| Designation |
Postgraduate resident- MD Anesthesiology |
| Affiliation |
Chettinad hospital and research institute |
| Address |
Second floor ICU-3, Department of Anesthesiology, Chettinad hospital and research institute, Chettinad health city, rajiv gandhi salai(OMR), Kelambakkam, Tamilnadu 603103
Kancheepuram TAMIL NADU 603103 India |
| Phone |
9487568525 |
| Fax |
|
| Email |
aswinigandhimathi98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad hospital and research institute, chettinad health city, rajiv gandhi salai,kelambakkam,chennai,tamilnadu,india-603103 |
|
|
Primary Sponsor
|
| Name |
Dr Aswini Gandhimathi R |
| Address |
Second floor ICU-3, Chettinad hospital and research institute, chettinad health city, rajiv gandhi salai,kelambakkam,chennai,tamilnadu,india-603103 |
| Type of Sponsor |
Other [This thesis is sponsored by myself] |
|
|
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 Aswini Gandhimathi R |
Chettinad hospital and research institute |
D-Block, first floor, Department of Anesthesiology, chettinad health city, rajiv gandhi salai, kelambakkam, chennai, tamilnadu,India-603103
Chennai
TAMILNADU Kancheepuram TAMIL NADU |
09487568525
aswinigandhimathi98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committe For Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant mothers with singleton fetus
Elective and Emergency LSCS
Patient Height- 150-180cm
American Society of Anesthesiologist(ASA) grade I,II
|
|
| ExclusionCriteria |
| Details |
parturient age less than 18 years and more than 40 years
Body mass index more than 40
Parturient with placenta previa
Eclampsia and pre-eclampsia
cardiovascular or cerebrovascular disease
Peripheral vascular disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To predict the incidence of post spinal hypotension from toe perfusion index of lower segment cesarean section patients. |
Baseline and post spinal anesthesia first 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To explore the correlation between toe Perfusion index and spinal hypotension and determine cut off value if any through ROC curves.
To assess the relationship between changes in the perfusion index in the right and left toe and incidence of post spinal hypotension
To analyse the differential perfusion index of upper limb and lower limb
|
Baseline and post spinal anesthesia first 30 minutes |
|
|
Target Sample Size
|
Total Sample Size="84" Sample Size from India="84"
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)
|
05/11/2025 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
To Predict the incidence of spinal hypotension using perfusion index from pulse oximetry of right and left toes in Lower segment cesarean section patients- A prospective Observational studyPrimary objective: To predict the incidence of post spinal hypotension from toe perfusion index of lscs patients. Secondary objective: To explore the correlation between toe Perfusion index and spinal hypotension and determine cut off value if any through ROC curves. To assess the relationship between changes in the perfusion index in the right and left toe and incidence of post spinal hypotension To analyse the differential perfusion index of upper limb and lower limb Inclusion criteria Age 18-40yrs Pregnant mothers with singleton fetus Elective and Emergency LSCS Patient Height- 150 to180cm
Exclusion criteria parturient age less than or equal to 18 years or more than or equal to 40 years Body mass index more than 40 Parturient with placenta previa Eclampsia and pre-eclampsia cardiovascular or cerebrovascular disease Peripheral vascular diseaseMethodology: After obtaining approval from Ethics committee. Informed and Written consent will be obtained from all patients .All patients will be instructed to fast for 8 hours for solid diet prior to surgery. All patients will be pre medicated with Tablet Metaclopromide 10 mg and Tab. Ranitidine 150 mg orally on the night before surgery and morning of surgery. Patients pre operative vitals will be recorded ( HR, BP, MAP, SPO2 and perfusion index ). An intravenous (IV) line will be established with an 18 G IV catheter in the dorsum of hand or wrist vein. All patients will be coloaded with Lactated ringer’s(RL) solution of approximately 500 ml. Standard monitoring with electrocardiography, non invasive blood pressure, pulse oximetry with perfusion index will be performed as per ASA guidelines .Baseline BP, MAP, HR, SPO2, PERFUSION INDEX will be monitored and noted. Pulse oximeter will be put on the left hand and right and left second toes of parturients in supine position for continuous monitoring of toe and hand perfusion index until the fetus is delivered .The perfusion index of upper limb and right and left toe will be noted 5mins before spinal anasthesia in supine position. Under sterile aseptic precautions all patients will receive subarachanoid block at L3-L4 or L4-L5, level with patients in sitting position using 25 or 26 G Quincke needle. After cerebrospinal fluid is detected Inj 0.5% Bupivacaine(Hyperbaric)2ml with buprenorphine 0.2ml is administered.By use of a cold swab level of sensory block will be checked 5 min after spinal injection before starting surgery. Oxygen will be attached by use of face mask at 4 L/min to parturient after returned to supine position. After spinal anaesthesia, Heart rate (HR), Systolic blood pressure (SBP), Diastolic blood pressure (DBP), Mean arterial pressure (MAP), perfusion index (PI), saturation (SpO2) & respiratory rate(RR) will be recorded at 3 min intervals till the delivery of baby.The perfusion index of left hand and right and left toe will be noted 5mins after spinal anesthesia in supine position. Decrease in Systolic blood pressure less than 20% from the baseline SBP will be characterized as hypotension .Hypotension will be treated with IV fluid (Ringer lactate/normal saline),if required vasopressors (Ephedrine, Phenylephrine, Noradrenaline. Any adverse effects like nausea, vomiting ,headache, bradycardia will be treated accordingly.
|