| CTRI Number |
CTRI/2020/01/023044 [Registered on: 30/01/2020] Trial Registered Prospectively |
| Last Modified On: |
29/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Using pulse oximeter as a simple tool to detect presence of decreased blood flow in the legs due to block in the arteries |
|
Scientific Title of Study
|
Pulse oximetry as a tool to detect peripheral arterial disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anupa A Shetty |
| Designation |
Junior resident |
| Affiliation |
Department of general medicine, Kasturba medical college, Manipal |
| Address |
Department of general medicine, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9740589560 |
| Fax |
|
| Email |
anupashetty1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raviraja Acharya |
| Designation |
Professor and head of the department |
| Affiliation |
Department of general medicine, Kasturba medical college, Manipal |
| Address |
Department of general medicine, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9141371000 |
| Fax |
|
| Email |
rvacharya@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Anupa A Shetty |
| Designation |
Junior resident |
| Affiliation |
Department of general medicine, Kasturba medical college, Manipal |
| Address |
Department of general medicine, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9740589560 |
| Fax |
|
| Email |
anupashetty1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of general medicine, Kasturba Medical College, Madhavnagar, Manipal, 576104 |
|
|
Primary Sponsor
|
| Name |
Department of general medicine Kasturba medical college |
| Address |
Department of general medicine, Kasturba Medical College, Manipal |
| 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 Anupa A Shetty |
Kasturba Medical college |
Department of general medicine, Kasturba Medical College Manipal
Udupi
KARNATAKA |
9740589560
anupashetty1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I702||Atherosclerosis of native arteriesof the extremities, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with symptoms suggestive of PAD.
Asymptomatic patients with risk factors for PAD(mainly T2DM, hypertension and smoking)
|
|
| ExclusionCriteria |
| Details |
Age less than 40
Known history of cardiac failure
Toes with gangrene or dystrophic nails
History of raynaud’s phenomenon
Hemodynamic instability
Patient on drugs causing peripheral vasodilation
Patients on oxygen supplementation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determine sensitivity and specificity of pulse oximeter to detect peripheral arterial disease compared to standard arterial doppler ultrasonography |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare sensitivity and specificity of pulse oximetry with that of ankle brachial pressure index to detect peripheral arterial disease
To study association between peripheral arterial disease and atherothrombotic complications like stroke and ischemic heart disease. |
2 years |
|
|
Target Sample Size
|
Total Sample Size="246"
Sample Size from India="246"
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)
|
30/01/2020 |
| 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="1"
Months="11"
Days="8" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The primary purpose of the study is to determine the efficacy of pulse oximeter as a tool for detecting peripheral arterial disease in comparison to the standard diagnostic procedure that is arterial doppler ultrasonography. The secondary objective of being studying the association between peripheral arterial disease and atherothrombotic complications like stroke and ischemic heart disease.
Study hypothesis: The sensitivity and specificity of pulse oximeter in detecting peripheral arterial disease is comparable to that of arterial doppler ultrasonography
|