| CTRI Number |
CTRI/2024/09/073654 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Temperature measurement in the emergency cesarean section undergoing mothers under spinal anaesthesia |
|
Scientific Title of Study
|
Temperature monitoring with Zeroflux Probe in Parturient undergoing Emergency Cesarean Section under Spinal Anaesthesia – An 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 Sivakaran R |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Department of Anesthesiology and critical care,2nd floor institute block, JIPMER campus, Pondicherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7010785851 |
| Fax |
|
| Email |
1998sankarravi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priya rudingwa |
| Designation |
Additional professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Department of Anesthesiology and critical care,
Ipd block 2nd floor,
JIPMER.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8903468132 |
| Fax |
|
| Email |
priyaab8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sivakaran R |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal institute of medical education and research |
| Address |
Department of Anesthesiology and critical care, 2nd floor institute block, JIPMER campus, Pondicherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7010785851 |
| Fax |
|
| Email |
1998sankarravi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal institute of post graduate medical education and research ( Intramural fund ) pondicherry |
|
|
Primary Sponsor
|
| Name |
Jawaharlal institute of postgraduate medical education and research |
| Address |
JIPMER campus road,Gorimedu, Dhanvantri nagar, Pondicherry 605006 |
| 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 |
| Dr Sivakaran R |
Jawaharlal institute of post graduate medical education and research |
Department of Anesthesiology and critical care office,
Second floor institute block,
JIPMER,
Gorimedu,
Pondicherry.
Pondicherry
PONDICHERRY |
7010785851
1998sankarravi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee Jipmer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil since its an observational study |
Nil since its an observational study |
| Intervention |
Nil since its an observational study |
Nil since its an observational study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Emergency cesarean section under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Patients planned for the section under GA
2. Failed or inadequate neuraxial technique, converted to GA
3. Patients with preexisting fever or sepsis.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the incidence of hypothermia in patients undergoing emergency cesarean section under spinal anesthesia |
5 minutes after they shifted to PACU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a)To determine the association of maternal hypothermia with the following,
1.Baseline maternal temperature
2.Maternal temperature during delivery
3.Duration of surgery
4.Amount of IV fluids administered
b)To measure the usage of warm IV fluids (37-41ºC),warming blankets and forced air warmers in emergency cesarean section.
|
During surgery and in PACU |
|
|
Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
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)
|
20/12/2024 |
| 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
Modification(s)
|
Parturient scheduled for emergency cesarean section under spinal anaesthesia will be recruited after getting informed and written consent.Ambient room temperature of the operation theatre will be recorded.After shifting into the operating room along with standard ASA monitors, zero flux temperature probe will be attached to the patient’s forehead.Then the patient will be positioned for spinal anaesthesia,0.5% hyperbaric bupivacaine 1.8-2ml will be given.Patients will be turned supine with wedge under right hip.Level of the sensory block will be assessed by pinprick test, incision will be given once the level of T4-T6 is achieved.Baseline temperature will be recorded and the temperature will be measured every 10 minutes using the zero flux temperature probe .The usage of warm fluids, forced air warmers, blankets will be recorded.Total Blood loss will also be recorded..Episodes of shivering and usage of rescue drug pethidine will be noted.The temperature monitoring will be continued till the patient is in PACU for 1 hour.Temperature measured using the zero flux temperature probe after 5 minutes of shifting the patient to PACU will be considered as a exact point to define hypothermia.Thermal comfort score also be recorded at immediately after shifting to operating room, immediately after spinal,30 mins after spinal, before shifting to PACU in operating room, 5 minutes after shifting to PACU, 30 minutes after shifting to PACU
|