| CTRI Number |
CTRI/2024/04/066465 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study at Sawai Man Singh Medical College and Attached Hospitals, Jaipur to Find Out the Number of Patients Having Reduced Heart Rate in Lying Down Position, Reduced Blood Pressure in Lying Down Position and Fall in Blood Pressure in Sitting Position Among Patients of Spine Injury |
|
Scientific Title of Study
|
An Observational Study to Estimate the Prevalence of Resting Bradycardia, Resting Hypotension and Orthostatic Hypotension in Chronic Traumatic Spinal Cord Injury Patients in Sawai Man Singh Medical College and Attached Hospitals, Jaipur |
| 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 Anagha V Nair |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Department of Physical Medicine and Rehabilitation
Rehabilitation Research Centre
SMS Medical College Jaipur
Jaipur
Rajasthan
PIN 302004
India
Jaipur
RAJASTHAN
302004
India |
| Phone |
9400530742 |
| Fax |
|
| Email |
anaghaviswanadhanmathil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeshwari Jindal |
| Designation |
Guide Senior Professor and Head of Department |
| Affiliation |
SMS MEDICAL COLLEGE JAIPUR |
| Address |
Department of Physical Medicine and Rehabilitation
Rehabilitation Research Centre
SMS Medical College Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9314246290 |
| Fax |
|
| Email |
dr.rjindal@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajeshwari Jindal |
| Designation |
Guide Senior Professor and Head of Department |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Department of Physical Medicine and Rehabilitation
Rehabilitation Research Centre
SMS Medical College Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9314246299 |
| Fax |
|
| Email |
dr.rjindal@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SMS Medical College Jaipur |
| Address |
Department of Physical Medicine and Rehabilitation
SMS Medical College Jaipur
Jaipur
Rajasthan
PIN 302004
India |
| Type of Sponsor |
Government 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 Rajeshwari Jindal |
Sawai Man Singh Medical College Jaipur |
Paraplegic Wards 1 and 2 Male Wards 1 and 2 and Paraplegic Female Ward
Department of Physical Medicine and Rehabilitation
Rehabilitation Research Centre
SMS Medical College Jaipur
PIN 302004
Jaipur
RAJASTHAN |
9314246290
dr.rjindal@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Ethics Committee SMS Medical College and Attached Hospitals Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S14||Injury of nerves and spinal cord at neck level, (2) ICD-10 Condition: S24||Injury of nerves and spinal cord at thorax level, (3) ICD-10 Condition: S34||Injury of lumbar and sacral spinalcord and nerves at abdomen, lower back and pelvis level, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Study is observational |
| Intervention |
Nil |
Stuy is observational |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients willingly giving an informed written consent to participate in study
Patients with traumatic Spinal Cord Injury of duration more than 3 months admitted under department of PMR, SMSMC, Jaipur
Patients with SCI of ASIA grades A, B, C or D |
|
| ExclusionCriteria |
| Details |
Patients who are unable to cooperate with the study
Previously known cardiac comorbidity or disease prior to the spinal cord injury or taking medications having effects on CVS
Head injury or prior neurological disorders like Parkinson’s disease , diabetic autonomic neuropathy or any peripheral neuropathy
Present history of neurogenic shock or hypovolemic shock
Prior history of psychiatric disorders or drug abuse
Completely bedridden patients who are unable or not allowed to sit due to medical illness
Severe anemia or pyrexia
Patients participating in any other study currently
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Heart rate in supine and sitting position
2. Systolic blood pressure in supine and sitting position
3. Diastolic blood pressure in supine and sitting position |
Heart rate, systolic blood pressure and diastolic blood pressure in sitting position should be checked within 3 minutes of sitting in sit up test or at the development of symptoms of hypotension after sitting whichever is earlier |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Duration of injury
2.Age
3.Sex
4.ASIA Grade of SCI (A,B,C or D)
5.Vertebral level of
injury |
At the point of first interview |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
10/05/2024 |
| 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
|
This is an observational study to find out the prevalence of resting bradycardia, resting hypotension and orthostatic hypotension in chronic spinal cord injury that will be conducted in the Department of Physical Medicine and Rehabilitation, SMS Medical College, Jaipur in India. Spinal cord injury (SCI) is one of the most catastrophic traumatic events. Disruption of autonomic pathways makes a highly unstable cardiovascular system which manifests as impaired heart rate and BP regulation with sudden fluctuations which causes significant distress and problems in rehabilitation of spinal cord injury patients. Purpose of this study is to find out the prevalence of resting bradycardia, resting hypotension and orthostatic hypotension in chronic traumatic spinal cord injury patients, assess the association of heart rate with resting hypotension and orthostatic hypotension in these cases and to check whether resting bradycardia, resting hypotension, level, completeness and duration of injury can be used as predictors to orthostatic hypotension for the improvement of the health related quality of life and decrease morbidity and mortality after SCI.
|