| CTRI Number |
CTRI/2015/04/005685 [Registered on: 08/04/2015] Trial Registered Retrospectively |
| Last Modified On: |
18/03/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Continous Hemoglobin Monitoring For Ongoing Blood Loss During Cancer Surgeries Without Needle Prick |
|
Scientific Title of Study
|
To Study The Utility Of Non-Invasive Spectrophotometric Hemoglobin (SpHb) Monitoring During Major Oncological Surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Namrata Gupta |
| Designation |
Resident |
| Affiliation |
Rajiv Gandhi Cancer Institute And Research Centre |
| Address |
3rd Floor, OT Complex,
Department Of Anesthesia,
Rajiv Gandhi Cancer Institute,
Sector 5 Rohini,
New Delhi
Sector 5, Rohini
New Delhi
DELHI
110085
India |
| Phone |
918527182855 |
| Fax |
|
| Email |
drnamratagupt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Kulkarni |
| Designation |
Senior Consultant |
| Affiliation |
Rajiv Gandhi Cancer Institute And Research Centre |
| Address |
3rd Floor, OT Complex,
Department Of Anesthesia,
Rajiv Gandhi Cancer Institute,
Sector 5 Rohini,
New Delhi
Sector 5, Rohini
North West
DELHI
110085
India |
| Phone |
9891064785 |
| Fax |
|
| Email |
anitackulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Namrata Gupta |
| Designation |
Resident |
| Affiliation |
Rajiv Gandhi Cancer Institute And Research Centre |
| Address |
H.No.43, Pocket C-7, Sector-7, Rohini
SECTOR 5, ROHINI
North West
DELHI
110085
India |
| Phone |
918527182855 |
| Fax |
|
| Email |
drnamratagupt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi Cancer Hospital and Research Institute , Sector 5, Rohini, New delhi-85 |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Cancer Institute |
| Address |
sector 5, rohini, new delhi |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Namrata Gupta |
3rd Floor OT Complex,Department Of Anesthesia |
Rajiv Gandhi Cancer Institute And Research Centre,
Sector 5, Rohini
New Delhi
DELHI |
8527182855
drnamratagupt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients undergoing major oncological surgeries involving major blood loss, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Laboratory Hemoglobin (LabHb) |
it is a standard method to measure blood hemoglobin in laboratory settings. |
| Intervention |
Non-invasive Spectrophotometric Hemoglobin (SpHb) |
it is done using Pulse Co-Oximeter which works n principle similar to pulse oximeter and uses a multi-wavelength sensor to distinguish between oxygenated blood, deoxygenated blood, blood with carbon monoxide, blood with oxidized hemoglobin and blood plasma. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
- ASA Grade I, II, III patient undergoing major elective oncosurgeries with expected blood loss more than 20% of blood volume |
|
| ExclusionCriteria |
| Details |
- Patient with known Hemoglobinopathies, arrhythmias, severe hypotension.
- Peripheral Vascular disease like Raynaud’s disease.
- Any skin abnormalities affecting the digits.
- Patient on antipsychotic drugs and patient having high total bilirubin levels.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Real time hemoglobin monitoring for faster assessment of blood loss and effective decision making for blood transfusion during intraoperative period. |
every time blood loss exceed 500 ml or hourly whichever is earlier |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| requirement of postoperative blood transfusion and any complication due to intraoperative blood loss and transfusion. |
up to 48hrs. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/08/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Synopsis Of Study Protocol Submission Department: Department Of Anesthesiology And Intensive Care, Rajiv Gandhi Cancer Institute And Research Centre Candidate: Dr. Namrata Gupta, DNB Resident Anesthesiology. Title: To Study The Utility Of Non-Invasive Spectrophotometric Hemoglobin (Sphb) Monitoring During Major Oncological Surgeries. Aim: To evaluate the efficacy of SpHb in managing blood transfusions during intraoperative period using Radical-7®; Masimo Corp. in centre with high volume of oncosurgeries involving major blood loss. Objective: To study and compare the of SpHb values with Laboratory Hemoglobin (LabHb) values by using Radical-7®; Masimo Corp., Irvine, CA and COULTER® LH 750 Hematology Analyzer respectively during major oncological surgeries in following aspects; 1. Accuracy of SpHb in comparison with LabHb 2. Accuracy of SpHb as transfusion trigger in comparison with LabHb. 3. Correlation of SpHb and perfusion index. Inclusion Criteria: - ASA Grade I, II, III patient undergoing major elective oncosurgeries with expected blood loss more than 20% of blood volume between Age group above 18 years and preoperative hemoglobin 8-14gm/dl. Exclusion Criteria: - Patient with known Hemoglobinopathies, arrhythmias, severe hypotension. - Peripheral Vascular disease like Raynaud’s disease. - Any skin abnormalities affecting the digits. - Patient on antipsychotic drugs and patient having high total bilirubin levels. Study Protocol: Informed written consent will be taken from 50 patients undergoing surgery with anticipated blood loss of >20% of blood volume. Continuous SpHb monitoring will be done using Radical-7®; Masimo Corp., and LabHb will be sent at specific time points at blood loss of every 500ml and its multiples. Blood transfusion will be managed on the basis of clinical criteria and SpHb values of 8-10 gm% as per order by attending anesthesiologist. Study design will be prospective case control study. Source of funding: nil Conflict of interest: nil |