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CTRI Number  CTRI/2017/11/010459 [Registered on: 10/11/2017] Trial Registered Prospectively
Last Modified On: 09/11/2017
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Comparing two methods of measuring heart performance  
Scientific Title of Study   Functional hemodynamic monitoring using Continuous Non invasive Arterial Pressure (CNAP) and Capstesia software 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anamika Kansal 
Designation  DNB Anesthesiology Resident 
Affiliation  Rajiv Gandhi Cancer Institute and Research Centre Sector-5; Rohini; New Delhi - 110085 
Address  Major OT, 3rd Floor, Old Building Division; Department of Anesthesiology; Rajiv Gandhi Cancer Institute and Research Centre Sector-5; Rohini; New Delhi

North West
DELHI
110085
India 
Phone  9466053123  
Fax    
Email  anamikakansal89@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Col A K Bhargava 
Designation  Director and Head, Department of Anesthesiology 
Affiliation  Rajiv Gandhi Cancer Institute and Research Centre Sector-5; Rohini; New Delhi - 110085 
Address  Major OT -Director Room, 3rd Floor, Old Building Division; Department of Anesthesiology; Rajiv Gandhi Cancer Institute and Research Centre Sector-5; Rohini; New Delhi

North West
DELHI
110085
India 
Phone  9466053123  
Fax    
Email  bhargava.ak@rgcirc.org  
 
Details of Contact Person
Public Query  
Name  Dr Anamika Kansal 
Designation  DNB Anesthesiology Resident 
Affiliation  Rajiv Gandhi Cancer Institute and Research Centre Sector-5; Rohini; New Delhi - 110085 
Address  Major OT, 3rd Floor, Old Building Division; Department of Anesthesiology; Rajiv Gandhi Cancer Institute and Research Centre Sector-5; Rohini; New Delhi

North West
DELHI
110085
India 
Phone  9466053123  
Fax    
Email  anamikakansal89@gmail.com  
 
Source of Monetary or Material Support  
Department of Finance; Rajiv Gandhi Cancer Institute & Research Center, Sec 5, Near Rohini West Metro Station, Rohini, New Delhi - 110085 
 
Primary Sponsor  
Name  Rajiv Gandhi Cancer Institute and Research Centre 
Address  Rajiv Gandhi Cancer Institute and Research Centre, Near Rohini West Metro Station, Sector - 5, Rohini, New Delhi-110085, India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anamika Kansal  Rajiv Gandhi Cancer Institute and Research Centre Sector-5; Rohini; New Delhi - 110085  Operation Theatre, Third Floor, Old Building Division; Department of Anesthesiology; Rajiv Gandhi Cancer Institute and Research Centre, Sec 5, Rohini, New Delhi 110085
North West
DELHI 		 9466053123
9466053123
anamikakansal89@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients requiring advanced hemodynamic monitoring during surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1) ASA physical status II and III
2) Adult patients (18 - 75 yrs) of age
3) Either sex
4) Patients with a clinical need for invasive arterial pressure (IAP) monitoring
5) Expected duration of anesthesia > 120 min
6) Body mass index (BMI) between 18.5 - 30.0 kg/m2
7) Weight between 45 - 85 kgs 
 
ExclusionCriteria 
Details  1) Patients with advanced dysfunction of peripheral perfusion (e.g. arterial peripheral artery occlusive disease, Raynaud’s syndrome), arteriovenous shunts for hemodialysis
2) Any history of vascular surgery of the upper extremities
3) History of cardiac arrhythmia
4) Refusal to provide informed consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Cardiac Output measured by CNAP/ Capstesia combination   5 mins, 10 mins, 15 mins, 20 mins, 25 mins, 30 mins, 35 mins, 40 mins, 45 mins, 50 mins, 55 mins, 60 mins, 65 mins, 70 mins, 75 mins, 80 mins, 85 mins, 90 mins, 95 mins, 100 mins, 105 mins, 110 mins, 115 mins, 120 mins 
 
Secondary Outcome  
Outcome  TimePoints 
Pulse Pressure Variation (PPV) measured by Capstesia  5 mins, 10 mins, 15 mins, 20 mins, 25 mins, 30 mins, 35 mins, 40 mins, 45 mins, 50 mins, 55 mins, 60 mins, 65 mins, 70 mins, 75 mins, 80 mins, 85 mins, 90 mins, 95 mins, 100 mins, 105 mins, 110 mins, 115 mins, 120 mins 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   N/A 
Date of First Enrollment (India)   01/01/2018 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This is a single blind, prospective, observational, single arm, single centric, cohort study comparing the conventional cardiac output monitor Vigileo TM and IAP (Invasive arterial pressure) combination with the new smartphone based application Capstesia TM and CNAP (Continuous non invasive arterial pressure) combination in 50 consecutive adult patients undergoing major surgery requiring cardiac output monitoring. The primary outcome measure will be cardiac output measured by Capstesia TM at time points 5, 10 , 15, 20, 25, 30, 35, 40 , 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120 minutes post surgical incision. The secondary outcome measure would be the Pulse pressure variation (PPV) measured by Capstesia TM at time points 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120 minutes post surgical incision. 
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