| CTRI Number |
CTRI/2024/10/076045 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the depth between skin and spinal fluid level using ultrasound, patient body habitus and the actual depth |
|
Scientific Title of Study
|
A STUDY OF ASSOCIATION BETWEEN ULTRASONOGRAPHIC MEASUREMENT , ANTHROPOMETRIC MEASUREMENT, AND ACTUAL DEPTH OF SUBARACHNOID SPACE IN ALL ADULT PATIENTS UNDERGOING SPINAL ANAESTHESIA. |
| 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 Dharani |
| Designation |
junior resident |
| Affiliation |
sree balaji medical college and hospital |
| Address |
Fourth floor ORC
department of anaesthesia
sree balaji medical college and hospital
CLC works road
chrompet
chennai 600044
Chennai
TAMIL NADU
600044
India |
| Phone |
9790797289 |
| Fax |
|
| Email |
crazydharu0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetha soundarya |
| Designation |
associate professor |
| Affiliation |
sree balaji medical college and hospital |
| Address |
Fourth floor ORC
department of anaesthesia
sree balaji medical college and hospital
clc works road
chrompet
chennai 600044
Chennai
TAMIL NADU
600044
India |
| Phone |
9444570135 |
| Fax |
|
| Email |
gsound15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dharani M |
| Designation |
MD Anaesthesia |
| Affiliation |
sree balaji medical college and hospital |
| Address |
Third floor
department of anaesthesia
sree balaji medical and hospital
clc works road
chrompet
chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9790797289 |
| Fax |
|
| Email |
crazydharu0@gmail.com |
|
|
Source of Monetary or Material Support
|
| sree balaji medical college and hospital,chrompet,chennai-600044. |
|
|
Primary Sponsor
|
| Name |
Sree Balaji medical college |
| Address |
department of anaesthesia
sree balaji medical college and hospital
CLC works road
chrompet
chennai-600044 |
| Type of Sponsor |
Private medical college |
|
|
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 Dharani |
sree balaji medical college and hospital |
5 star ORC COMPLEX
Fourth floor
sree balaji medical college and hospital,
CLC works road,
chrompet,
chennai-600044.
Chennai
TAMIL NADU |
9790797289
crazydharu0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sree Balaji Medical college and hospital Institutional Human Ethics 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
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II standards
patients undergoing various elective surgeries under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
patient refusal
pregnant patient
ASA III standard and above
kyphosis,scoliosis, lordosis
bleeding disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO Observe pre puncture estimation of subarachnoid space depth using ultrasound may guide spinal needle placement and help to reduce failure rate and complication associated with lumbar puncture. |
5 minutes before surgery spinal depth measured using ultrasound machine and 1 minute after spinal real spinal depth measured using spina needle marker point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pre op spinal depth & post op spinal needle real depth measurement |
pre & post operative period
5 minutes before surgery spinal depth measured using ultrasound machine & 1 minute after spinal real spinal depth measured using spina needle marker point |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
24/11/2024 |
| 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 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
|
A pre puncture estimation of subarachnoid space depth using ultrasound may guide spinal needle placement and help to reduce failure rate and complication associated with lumber puncture. Our aim of study was to determine SSD using anthropometric, ultra-sonographic and actual depth by needle insertion and to compare them. A subarachnoid space depth estimate has been shown to function as a depth guide for proper needle placement. It reduces the number of failed or repeated attempts, as well as traumatic or bloody taps. |