Observational and Minimal Interventional Study Designed to Collect Data During Planned Surgery

Completed

• Conditions: Elective, Non-thoracic, Open surgical procedures

• Registration Number: CTRI/2015/03/005657
• Lead Sponsor: Nellcor Puritan Bennett LLC Doing Business as Covidien

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-30
• Last Update Posted: 2015-11-16

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• • 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.

Exclusion Criteria

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Not Applicable (data collection study)	Not Applicable (data collection study)

Secondary Outcome Measures

Name	Time	Method
Not Applicable (data collection study)	Not Applicable

Trial Locations

Locations (1)

M S Ramaiah Medical College & Hospitals; 🇮🇳 Bangalore, KARNATAKA, India

M S Ramaiah Medical College & Hospitals

🇮🇳Bangalore, KARNATAKA, India

Dr Geetha C Rajappa

Principal investigator

09900482828

Jageedha@yahoo.com