| CTRI Number |
CTRI/2024/08/071844 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE OBSERVATIONAL STUDY |
| Study Design |
Other |
|
Public Title of Study
|
Perfusion index as primary indicator in pediatric infraumbilical surgeries in caudal block. |
|
Scientific Title of Study
|
Perfusion index as primary predictor of successful caudal block in infraumbilical and lower limb pediatric surgeries: 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 |
SONAL SAGAR KHATAVKAR |
| Designation |
PROFESSOR |
| Affiliation |
Dr DY PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY.DR D.Y.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE.
Pune
MAHARASHTRA
411018
India |
| Phone |
9820434472 |
| Fax |
|
| Email |
drsonalkhatavkar@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
SRAVYA BEJUGAMA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Dr DY PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
DEPARTMENT OF ANAESTHESIA,, Dr DY PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE , PIMPRI , PUNE , MAHARASHTRA
Pune
MAHARASHTRA
411018
India |
| Phone |
6309360245 |
| Fax |
|
| Email |
drsravya243b@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SRAVYA BEJUGAMA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Dr DY PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
DEPARTMENT OF ANAESTHESIA, Dr DY PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE , PIMPRI , PUNE , MAHARASHTRA
Pune
MAHARASHTRA
411018
India |
| Phone |
6309360245 |
| Fax |
|
| Email |
drsravya243b@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR.D Y PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE. |
|
|
Primary Sponsor
|
| Name |
Dr DY PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
Dr DY PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, SANT TUKARAM NAGAR, PIMPRI COLONY , PIMPRI CHINCHWAD , PUNE , MAHARASHTRA , INDIA 411018 |
| 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 SRAVYA BEJUGAMA |
Dr.D.Y.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
Department of Anaesthesia , Dr.D.Y.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE.
Pune
MAHARASHTRA |
6309360245
drsravya243b@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH AND RECOGNITION COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
a. ASA grade I or II fit patients.
b. Ages between 1 and 8 years of either sex.
c. Patients undergoing elective infraumbilical and lower limb pediatric surgeries.
d. Acceptance of study and signing informed consent. |
|
| ExclusionCriteria |
| Details |
a. Patients with ASA physical status ill or more.
b. Patients posted for emergency procedures.
c. Patients with history of spine pathology, anomalies or deformities.
d. Patients with bleeding disorders, infections. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess perfusion index as primary reliable indicator of successful caudal block in infra-umbilical and lower limb pediatric surgeries. |
4 and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess heart rate,systolic blood pressure,diastolic blood pressure,mean arterial prior & after caudal block. |
4 & 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
16/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/08/2024 |
| 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 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
|
To assess perfusion index as primary reliable indicator of successful caudal block in infra umbilical and lower limb pediatric surgeries. |