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Comparing two methods of measuring heart performance

Not yet recruiting
Conditions
Patients requiring advanced hemodynamic monitoring during surgery
Registration Number
CTRI/2017/11/010459
Lead Sponsor
Rajiv Gandhi Cancer Institute and Research Centre
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
50
Inclusion Criteria
    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.
Exclusion Criteria
  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.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Cardiac Output measured by CNAP/ Capstesia combination5 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 Measures
NameTimeMethod
Pulse Pressure Variation (PPV) measured by Capstesia5 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

Trial Locations

Locations (1)

Rajiv Gandhi Cancer Institute and Research Centre Sector-5; Rohini; New Delhi - 110085

🇮🇳

West, DELHI, India

Rajiv Gandhi Cancer Institute and Research Centre Sector-5; Rohini; New Delhi - 110085
🇮🇳West, DELHI, India
Dr Anamika Kansal
Principal investigator
9466053123
anamikakansal89@gmail.com

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