Clinical Investigation of Wireless Transmission of Invasive Blood Pressure Signal

The purpose of this study is to determine whether wireless transmission of invasive arterial blood pressure signal (by HMW 10 Wireless System) from patient to patient's bedside monitor is feasible, safe and as accurate as conventional cable connection.

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Key information

Conditions

Multiple Trauma Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative/Postoperative Complications Postoperative Complications Shock Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

The technology for invasive arterial blood pressure measurement in emergency room, operating theater, recovery room and intensive care unit is well established and uses pressure sensor connected via cable to patient's bedside monitor. The wireless sensors result in reduction of wires attached to the patient and may enhance nursing, treatment and transportation of patients in aforementioned setting.

The HMW 10 Wireless System was developed and incorporates wireless transmission of patient's signal. The purpose of the study was to measure the quality of data transmitted through the HMW 10 Wireless System, and to demonstrate that the quality of the data meets the requirements of European Directive 93/42/EEC (Medical Device Directive - MDD) and EN/IEC 60601-1 and EN/IEC 60601-2-34.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

ICU patients requiring invasive blood pressure monitoring

Exclusion criteria

frequent blood sampling through arterial cannula (more than 3 times a day)

Treatment and study plan

Wireless invasive blood pressure monitoring (Hybymed® Wireless IBPM System)

Device

The readings of invasive arterial pressure were obtained from 2 identical pressure transducers, connected to a common arterial line via a Y connector. Data was collected from one transducer via a direct cable connection and from the second transducer via wireless transmission of the signal to the patient's bedside monitor using the HMW 10 Wireless System.

A comparison of data received by patient's bedside monitor from the two transducers was done (standard connection vs. wireless connection), as well as a comparison of data collected by the transmitter and data received by the receiver of the HMW 10 Wireless System.

Other names: Hybymed® Wireless IBPM System HMW10. Hyb d.o.o., Slovenia

Primary outcomes

Difference between wired and wireless invasive arterial blood pressure

Time frame: 24 hours of monitoring

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Collaborators

Hyb, d.o.o., Slovenia

Registry information

Official study title

Feasibility and Accuracy of Wireless Transmission of Invasive Blood Pressure Signal From Patient to Patient's Bedside Monitor

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Jun 15, 2011
Registry last updated: Jun 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed