| CTRI Number |
CTRI/2020/06/025886 [Registered on: 15/06/2020] Trial Registered Prospectively |
| Last Modified On: |
12/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of breathing/respiratory rates obtained from Raybaby and GE B30 patient monitor among adults in the ICU |
|
Scientific Title of Study
|
Clinical pilot study to find agreement between the respiratory rates obtained by raybaby with HCGs respiration monitor equipment (GE B30 patient monitor) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali Palliyil Rajan |
| Designation |
Head of Clinical Intelligence and Applications |
| Affiliation |
rayIoT Solutions Inc |
| Address |
Clinical Intelligence and Applications
Dept of Research and Development
303
3RD FLOOR
136
Cears Plaza
Residency Road
Bengaluru
16192 Coastal Highway, Lewes, Delaware, 19958, USA
Bangalore
KARNATAKA
560025
India |
| Phone |
9673637572 |
| Fax |
|
| Email |
anjali.p@raybaby.us |
|
Details of Contact Person
Scientific Query
|
| Name |
Anjali Palliyil Rajan |
| Designation |
Head of Clinical Intelligence and Applications |
| Affiliation |
rayIoT Solutions Inc |
| Address |
Clinical Intelligence and Applications
Dept of Research and Development
303
3RD FLOOR
136
Cears Plaza
Residency Road
Bengaluru
16192 Coastal Highway, Lewes, Delaware, 19958, USA
Bangalore
KARNATAKA
560025
India |
| Phone |
9673637572 |
| Fax |
|
| Email |
anjali.p@raybaby.us |
|
Details of Contact Person
Public Query
|
| Name |
Anjali Palliyil Rajan |
| Designation |
Head of Clinical Intelligence and Applications |
| Affiliation |
rayIoT Solutions Inc |
| Address |
Clinical Intelligence and Applications
Dept of Research and Development
303
3RD FLOOR
136
Cears Plaza
Residency Road
Bengaluru
16192 Coastal Highway, Lewes, Delaware, 19958, USA
Bangalore
KARNATAKA
560025
India |
| Phone |
9673637572 |
| Fax |
|
| Email |
anjali.p@raybaby.us |
|
|
Source of Monetary or Material Support
|
| RIoT Solutions Inc
16192 Coastal Highway, Lewes, Delaware, 19958, USA |
|
|
Primary Sponsor
|
| Name |
RIoT Solutions Inc |
| Address |
7029-K, Haycock Road, Falls Church, Virginia-221043, United States. |
| Type of Sponsor |
Other [Consumer Electronics] |
|
|
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 Vijay Raju Krupesh |
HCG Cancer Hospital |
ICU,2nd Floor, Tower 3 ICU, Kalinga Rao Rd, Sampangi Rama Nagara, Sampangi Rama Nagar, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA |
9741777665
dr.krupesh@hcgel.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HCG Central Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL, This is an observational study for comparing breathing rates from two devices and soes not involve an intervention. |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
General ICU patients |
|
| ExclusionCriteria |
| Details |
Patient with known lung issues |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To check the agreement between the respiratory rates between the GE B30 and raybaby among adults, aging between 18 to 80 in the intensive care unit.
|
Respiratory rates (parameter of evaluation) from both devices will be compared at time intervals from 5 seconds or more and will be assessed post completion of monitoring of respective patients, starting from a minimum of 4 hour. Observations will be compiled every 2 weeks.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To obtain usable respiration data with an average of 20% conversion rate from 4 to 10 hours of monitoring patients at periodic intervals of 5 minutes.
|
Respiratory rates (parameter of evaluation) from both devices will be compared at time intervals from 5 seconds or more and will be assessed post completion of monitoring of respective patients, starting from a minimum of 4 hours. Observations will be compiled every 2 weeks. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/06/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an observational study to evaluate the effectiveness of Raybaby breathing monitor with respect to a medically certified device to assess the suitability of Raybaby non contact breath monitoring technique for clinical use. The study is yet to begin and publication would be drafted at the end of the study to establish correlation with medical standards and relevance. |