| CTRI Number |
CTRI/2015/03/005657 [Registered on: 27/03/2015] Trial Registered Prospectively |
| Last Modified On: |
16/11/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Observational and Minimal Interventional Study Designed to Collect Data During Planned Surgery |
|
Scientific Title of Study
|
Prospective Observational and Interventional Study Designed to Collect Physiological Data During Elective Surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| COVMOPR0457 Version C dated 22-Dec-2014 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Geetha C Rajappa |
| Designation |
Associate Professor |
| Affiliation |
M S Ramaiah Medical College and Hospital |
| Address |
M S Ramaiah Medical College and Hospital
New BEL Road
MSRIT Post
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
09900482828 |
| Fax |
|
| Email |
Jageedha@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Partha Chatterjee |
| Designation |
Head Clinical Research and CTSM |
| Affiliation |
SIRO Clinpharm Pvt Ltd |
| Address |
SIRO Clinpharm Pvt Ltd
Kalpataru Prime 1st Floor Unit Nos 3 and 4
Plot No D-3 Road No 16 Wagle Industrial Estate
Thane West
Thane
MAHARASHTRA
400604
India |
| Phone |
022-61088000 |
| Fax |
022-61088081 |
| Email |
partha.chatterjee@siroclinpharm.com |
|
Details of Contact Person
Public Query
|
| Name |
Partha Chatterjee |
| Designation |
Head Clinical Research and CTSM |
| Affiliation |
SIRO Clinpharm Pvt Ltd |
| Address |
SIRO Clinpharm Pvt Ltd
Kalpataru Prime 1st Floor Unit Nos 3 and 4
Plot No D-3 Road No 16 Wagle Industrial Estate
Thane West
Thane
MAHARASHTRA
400604
India |
| Phone |
022-61088000 |
| Fax |
022-61088081 |
| Email |
partha.chatterjee@siroclinpharm.com |
|
|
Source of Monetary or Material Support
|
| Covidien Private Limited
103 Penang Road
#10-01 Visioncrest Commercial
Singapore 238467 |
|
|
Primary Sponsor
|
| Name |
Nellcor Puritan Bennett LLC Doing Business as Covidien |
| Address |
Covidien Private Limited
103 Penang Road
#10-01 Visioncrest Commercial
Singapore 238467 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Geetha C Rajappa |
M S Ramaiah Medical College & Hospitals |
Department of Anaesthesiology and Pain Medicine
M S Ramaiah Medical College & Hospitals
New BEL Road MSRIT Post Bangalore - 560054
Bangalore
KARNATAKA |
09900482828
Jageedha@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M S Ramaiah Medical College & Hospitals Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Elective, Non-thoracic, Open surgical procedures, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
• Adult patient ≥ 18 years of age scheduled for an elective, open non-thoracic surgical procedure.
• Expected duration of the surgical procedure to be ≥ 1.5 hours.
• Expected radial artery cannulation and ECG monitoring in the Operating Room.
• Measurement of Invasive Blood Pressure via Radial cannulation site
|
|
| ExclusionCriteria |
| Details |
Patients with active cardiac arrhythmia, indwelling intra-aortic balloon pump, Left Ventricular assist device, undergoing thoracic open surgery, having history of severe contact allergies to adhesive material e.g. pulse oximetry sensors etc, skin lesions or deformities on fingers and forehead, pregnant female and vulnerable patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Not Applicable (data collection study) |
Not Applicable (data collection study) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable (data collection study) |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/03/2015 |
| 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="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The objective of this observational study is to collect sufficient hemodynamic electronic data from adult subjects in the operating room to support Hemodynamic Algorithm development and bench testing. It is not a clinical validation study of any hemodynamic algorithm software nor will any investigational hemodynamic algorithm be deployed during this trial. Electronic physiological data prospectively collected with research staff timed observations and comments on both the laptop and Case Record Form (CRF) will support the development of the hemodynamic algorithms in the laboratory setting. The Key Medical Devices to be used in the study are are non-invasive Class II non-significant risk CE marked SpO2 sensors and pulse oximeter monitors. Additionally, the study would involve use of ‘Covidien Data Acquisition System (DAS)’, to record the pulse oximetry (SpO2) raw photoplethysmogram waveform and monitor physiological data. ‘Covidien Data Acquisition System (DAS)’ is a laptop based investigational data collection system meeting electrical safety testing. The Design of the study is primarily observational with only minimal intervention being infusion of a 500 cc bolus of a crystalloid to establish the subject hemodynamic response baseline prior to first incision and the connection of the blood pressure transducer to the arterial access site for measurement of invasive blood pressure for all subjects.
|