| CTRI Number |
CTRI/2020/03/024261 [Registered on: 25/03/2020] Trial Registered Prospectively |
| Last Modified On: |
25/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective |
| Study Design |
Other |
|
Public Title of Study
|
Determination of Accuracy of IVS Examination by Palpation Using Ultrasound |
|
Scientific Title of Study
|
Accuracy Level of Inter-vertebral Space Estimation by Palpation:The Ultrasonic Revelation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AMMU S |
| Designation |
POSTGRADUATE |
| Affiliation |
PSG Institute Of Medical Sciences and Rsearch (PSGIMSR) |
| Address |
NEWLADIES HOSTEL room 630 DEPARTMENT of ANAESTHESIOLOGY PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH
COIMBATORE
TAMIL NADU
DEPARTMENT of ANAESTHESIOLOGY PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH
COIMBATORE
TAMIL NADU
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9048704104 |
| Fax |
|
| Email |
ammus6750@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AMMU S |
| Designation |
POSTGRADUATE |
| Affiliation |
PSG Institute Of Medical Sciences and Rsearch (PSGIMSR) |
| Address |
DEPARTMENT of ANAESTHESIOLOGY PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH
COIMBATORE
TAMIL NADU
DEPARTMENT of ANAESTHESIOLOGY PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH
COIMBATORE
TAMIL NADU
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9048704104 |
| Fax |
|
| Email |
ammus6750@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AMMU S |
| Designation |
POSTGRADUATE |
| Affiliation |
PSG Institute Of Medical Sciences and Rsearch (PSGIMSR) |
| Address |
DEPARTMENT of ANAESTHESIOLOGY PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH
COIMBATORE
TAMIL NADU
DEPARTMENT Of ANAESTHESIOLOGY PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH
COIMBATORE
TAMIL NADU
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9048704104 |
| Fax |
|
| Email |
ammus6750@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DEPARTMENT of ANAESTHESIOLOGY |
| Address |
DEPARTMENT of ANAESTHESIOLOGY
PSGIMSR PEELMEDU COIMBATORE 641004 |
| Type of Sponsor |
Other [] |
|
|
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 |
| silvy anna varugese |
psg institute of medical sciences and research |
Department of Anesthesiology level 2 OR complex PSGIMSR PEELMEDU COIMBATORE 641004
Coimbatore
TAMIL NADU |
7012193690
drsilvyann@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional human ethics committee, PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1-3
PREGNANT AND NON PREGNANT |
|
| ExclusionCriteria |
| Details |
PATIENT REFUSAL TO PARTICIPATE IN STUDY
DRUG ALLERGY
ANY CONTRAINDICATION TO NEURAXIAL BLOCKADE |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the accuracy of identification of IVS with palpation using USG.
|
2 MONTHS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess the effect of demographic parameters, patient positioning and anaesthesiologist experience on the accuracy. |
2 months |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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)
|
27/03/2020 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ideal space for spinal anethesia is below connus medullaris to avaoid trauma to the cord. The intercristal line or tuffier’s line is the line joining the superior iliac crests which crosses the L4 vertebra or L4-L5 space. Adult conus medullaris ends at lower border of L1 bur it is variable. So selecting lower most space is crucial for safe neuraxial anesthesia. The most common method for selecting IVS is palpation based on Tuffier’s line , but its accuracy is less. USG is a less tome consuming , simple, non invasive and easy to learn technology , which can accurately identify the IVS.. Hence in this study ultrasound is used to evaluate the accuracy of palpation method to estimate the level of IVS. In addition the effect of demographic parameters , patient positioning and anersthesiologist experience in determining the accuracy will also be assessed. |