| CTRI Number |
CTRI/2024/02/063377 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
29/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Peet per reed ki haddi per sue laghane |
|
Scientific Title of Study
|
Development And Validation Of Bedside Scoring System To Predict Difficult Lumbar Puncture An Observational And Analytical 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 |
SURESH M |
| Designation |
PG Student |
| Affiliation |
Dr.SN Medical College |
| Address |
Dr.Suresh M, Department of Anesthesiology, MDM Hospital,Dr.SN Medical College Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
7373972382 |
| Fax |
|
| Email |
sureavathar1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNaveen Paliwal |
| Designation |
Associate Professor |
| Affiliation |
Dr. SN Medical College, Jodhpur |
| Address |
Department of Anesthesiology , Dr. SN Medical College,MDM Hospital Campus, Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9950230213 |
| Fax |
|
| Email |
drnaveenpaliwal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrNaveen Paliwal |
| Designation |
Associate Professor |
| Affiliation |
Dr. SN Medical College, Jodhpur |
| Address |
Department of Anesthesiology , Dr. SN Medical College,MDM Hospital Campus, Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9950230213 |
| Fax |
|
| Email |
drnaveenpaliwal@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr.SN Medical College, Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr.SN Medical College, Jodhpur |
| Address |
Dr. SN Medical College, Shastri Nagar, Residency Road, Jodhpur, Rajasthan. 342003 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suresh |
Mahatma Gandhi Hospital |
1st floor, PAC room, Department of Anesthesiology, DR.SN Medical College, Olympic road, Jalori gate, Bhistiyon ka bas
Jodhpur
RAJASTHAN |
7373972382
sureavathar1994@gmail.com |
| DrSuresh M |
Mathura Das Mathur Hospital |
Operation theatre first floor, Department of Anesthesiology, Dr SN Medical College, Jodhpur
Jodhpur
RAJASTHAN |
7373972382
sureavathar1994@gmail.com |
| Dr Suresh |
Umaid hospital |
1st floor, Operation theatre and PAC room, Oposite to Geeta bhavan,Sardarpura road
Jodhpur
RAJASTHAN |
7373972382
sureavathar1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Dr SN Medical College Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Below umbilical surgery |
|
| ExclusionCriteria |
| Details |
Less than 20 and morethan 80 years, pregnancy, local site infection, previous spine surgery, history of seizure |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine association between patients bedside parameter and lumbar puncture |
10 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Calculate relative risk significantly associated patients parameter and develop bedside scoring system. |
15 min |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
06/04/2024 |
| 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="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
|
The aim of study to develop and validate a simple bedside scoring system using patients variable and scoliometer HD app to predict difficult Lumber Puncture in patients undergoing elective infra umbilical surgery under subarachnoid block. Objective - To determine any association between patients bedside parameter and lumber puncture grade. Calculate relative risk significantly associated patients parameter and develop bedside scoring system. To evaluate the cutoff valve of the bedside scoring system to predict each Lumber Puncture grade using AUC of the ROC curve. |