| CTRI Number |
CTRI/2018/11/016246 [Registered on: 01/11/2018] Trial Registered Prospectively |
| Last Modified On: |
25/02/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Touchless camera based monitoring of health parameters
|
|
Scientific Title of Study
|
Clinical study of non-contact monitoring of Respiratory rate and Heart rate in non-acuity settings |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrTrevor Francis Sequeira |
| Designation |
Associate Professor,Critical Care |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Kasturba Medical College Manipal Academy of Higher Education
Madhav Nagar
Near Tiger Circle
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
trevor.sequeira@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
DrTrevor Francis Sequeira |
| Designation |
Associate Professor,Critical Care |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Kasturba Medical College Manipal Academy of Higher Education
Madhav Nagar
Near Tiger Circle
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
trevor.sequeira@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DrTrevor Francis Sequeira |
| Designation |
Associate Professor,Critical Care |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Kasturba Medical College Manipal Academy of Higher Education
Madhav Nagar
Near Tiger Circle
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
trevor.sequeira@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Philips India Limited
Philips Research
Philips Innovation Campus
Manyata Tech Park
Nagavara
Bangalore
Karnataka
560045 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Kasturba Medical College Manipal Academy of Higher Education
Madhav Nagar
Near Tiger Circle
Manipal
Karnataka 576104 |
| Type of Sponsor |
Research institution |
|
|
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 Trevor Sequeira |
Kasturba Medical College |
Burns ward
Manipal Academy of Higher Education
Madhav Nagar
Near Tiger Circle
Manipal
Udupi
KARNATAKA |
9886308207
trevor.sequeira@manipal.edu |
| Dr Trevor Sequeira |
Kasturba Medical College |
Medicine ward
Manipal Academy of Higher Education
Madhav Nagar
Near Tiger Circle
Manipal
Udupi
KARNATAKA |
9886308207
trevor.sequeira@manipal.edu |
| DrTrevor Francis Sequeira |
Kasturba Medical College |
Nephro Dialysis Ward
Manipal Academy of Higher Education
Madhav Nagar
Near Tiger Circle
Manipal
Udupi
KARNATAKA |
9886308207
trevor.sequeira@manipal.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| MAHE Ethics Committee |
Approved |
| Manipal Academy of Higher Education Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T300||Burn of unspecified body region, unspecified degree, (2) ICD-10 Condition: N189||Chronic kidney disease, unspecified, (3) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients in the recovery room post hemodialysis,
Patients in the general ward in non-acuity settings
Burns patients who are recovering in non-acuity settings
|
|
| ExclusionCriteria |
| Details |
Patients requiring acute care
Patients in high-acuity hospital settings
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective is to collect non-contact monitoring data in a non-acuity setting for developing algorithms to extract respiratory rate and heart rate. |
45 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
N/A |
|
|
Target Sample Size
|
Total Sample Size="158"
Sample Size from India="158"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="158" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/11/2018 |
| Date of Study Completion (India) |
30/01/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a observational Prospective study focusing on measuring respiratory rate and heart rate in a non – contact manner. The cases where the non-contact monitor will be used are in areas where the patient is recovering from a procedure or intervention. E.g. immediately post a hemodialysis session, burns case and patients in a medical ward. Our study aims at studying and identifying the appropriateness of using a non-contact monitoring system in a relatively low-acuity setting with the intention of improving surveillance and patient safety. |