| CTRI Number |
CTRI/2022/10/046378 [Registered on: 11/10/2022] Trial Registered Prospectively |
| Last Modified On: |
31/07/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Non randomized study |
| Study Design |
Other |
|
Public Title of Study
|
Spot analysis of hemoglobin through Pulse CO-Oximeter |
|
Scientific Title of Study
|
Spot Check Noninvasive Hemoglobin (SpHb) Data Collection |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SPOT0005 V1.0 Dated 28-Jul-2022 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Gaurij Hood |
| Designation |
Consultant Public Health Specialist |
| Affiliation |
Shrimad Rajchandra Hospital and Research Centre |
| Address |
Shrimad Rajchandra Hospital and Research Centre, Block 1,1st floor, Room No 16 (DEIC Manager)
Bilpudi, Dharampur
District- Valsad
Valsad
GUJARAT
396050
India |
| Phone |
9673879921 |
| Fax |
|
| Email |
gaurij.hood@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Gaurij Hood |
| Designation |
Consultant Public Health Specialist |
| Affiliation |
Shrimad Rajchandra Hospital and Research Centre |
| Address |
Shrimad Rajchandra Hospital and Research Centre, Block 1,1st floor, Room No 16 (DEIC Manager)
Bilpudi, Dharampur
District- Valsad
Valsad
GUJARAT
396050
India |
| Phone |
9673879921 |
| Fax |
|
| Email |
gaurij.hood@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Gaurij Hood |
| Designation |
Consultant Public Health Specialist |
| Affiliation |
Shrimad Rajchandra Hospital and Research Centre |
| Address |
Shrimad Rajchandra Hospital and Research Centre, Block 1,1st floor, Room No 16 (DEIC Manager)
Bilpudi, Dharampur
District- Valsad
Valsad
GUJARAT
396050
India |
| Phone |
9673879921 |
| Fax |
|
| Email |
gaurij.hood@gmail.com |
|
|
Source of Monetary or Material Support
|
| Masimo Corporation
52 Discovery, Irvine,
California, 92618 USA
|
|
|
Primary Sponsor
|
| Name |
Masimo Corporation |
| Address |
52 Discovery, Irvine,
California, 92618 USA |
| Type of Sponsor |
Other [Global Medical Technology Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gaurij Hood |
Shrimad Rajchandra Hospital and Research Centre |
Block 1,1st floor, Room No 16 (DEIC Manager)
Bilpudi, Dharampur
District- Valsad
Valsad
GUJARAT |
9673879921
gaurij.hood@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shrimad Rajchandra Hospital and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D569||Thalassemia, unspecified, (2) ICD-10 Condition: D571||Sickle-cell disease without crisis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Weight>3kg |
|
| ExclusionCriteria |
| Details |
• Skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as psoriasis, eczema, angioma, burns, scar tissue, substantial skin breakdown, nail polish, acrylic nails, infections, abnormalities, etc. • Subjects deemed not suitable for the study at the discretion of the investigator |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Noninvasive hemoglobin measurement (SpHb) using Masimo Pulse CO-Oximeter device and sensor in a variety subjects, including pediatric subjects, pregnant and non-pregnant adults, healthy individuals and sick patients, with hemoglobin range spanning from 3-18 g/dL . |
10 minutes interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Non invasive hemoglobin(SpHb) using Masimo Pulse Co-oximeter before Invasive measurement of Hemoglobin by Blood draw with atleast 15 minutes gap between these two measurements. |
Spot check analysis at an interval of 15 minutes between invasive and non-invasive measurement. |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="2000"
Final Enrollment numbers achieved (Total)= "2000"
Final Enrollment numbers achieved (India)="1660" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/10/2022 |
| Date of Study Completion (India) |
10/10/2025 |
| 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)?
Response - NO
|
|
Brief Summary
|
The objective of this clinical study is to collect data for noninvasive hemoglobin measurement (SpHb) using Masimo Pulse CO-Oximeter device and sensor in a variety subjects, including pediatric subjects, pregnant and non-pregnant adults, healthy individuals and sick patients, with hemoglobin range spanning from 3-18 g/dL. |