Clinical Investigation of Wireless Transmission of Invasive Blood Pressure Signal

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

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.

Study Overview

• Status: Completed
• Conditions: Shock; Atrial Fibrillation; Multiple Trauma; Perioperative/Postoperative Complications
• Intervention / Treatment: Device: Wireless invasive blood pressure monitoring (Hybymed® Wireless IBPM System)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 12

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Critically ill patients

Description

Inclusion Criteria:

• ICU patients requiring invasive blood pressure monitoring

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Wireless; Measuring of invasive arterial blood pressure through HMW10 Wireless System.	Device: Wireless invasive blood pressure monitoring (Hybymed® Wireless IBPM System); 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
Wired; Measuring of invasive arterial blood pressure through conventional wired technology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference between wired and wireless invasive arterial blood pressure	24 hours of monitoring

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Collaborators: Hyb, d.o.o., Slovenia
• Investigators: Principal Investigator: Primoz Gradisek, MD, UMC Ljubljana; Principal Investigator: Neva Pozar-Lukanovic, MD, MMsc, UMC Ljubljana

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: June 10, 2011
• First Submitted That Met QC Criteria: June 14, 2011
• First Posted (Estimate): June 15, 2011

Study Record Updates

• Last Update Posted (Estimate): June 15, 2011
• Last Update Submitted That Met QC Criteria: June 14, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Intensive care unit; Invasive blood pressure monitoring; Wireless Technology
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Wounds and Injuries; Arrhythmias, Cardiac; Atrial Fibrillation; Multiple Trauma; Postoperative Complications
• Other Study ID Numbers: HMW10