Clinical Investigation of Wireless Transmission of Invasive Blood Pressure Signal

Completed

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

• Registration Number: NCT01373996
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

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.

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 Timeline

• Status Verified: 2011-04
• Study Start: 2011-06
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Study First Submitted: 2011-06-10
• Study First Submitted QC: 2011-06-14
• Last Update Submitted: 2011-06-14
• Study First Posted: 2011-06-15
• Last Update Posted: 2011-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• ICU patients requiring invasive blood pressure monitoring

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Wireless	Wireless invasive blood pressure monitoring (Hybymed® Wireless IBPM System)	Measuring of invasive arterial blood pressure through HMW10 Wireless System.

Primary Outcome Measures

Name	Time	Method
Difference between wired and wireless invasive arterial blood pressure	24 hours of monitoring