Clinical Investigation of Wireless Transmission of Invasive Blood Pressure Signal

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373996
• Other study ID #: HMW10
• Status: Completed
• Phase: N/A
• First received: June 10, 2011
• Last updated: June 14, 2011
• Start date: June 2011
• Est. completion date: June 2011

Study information

• Verified date: April 2011
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Agency for Medicinal Products - Ministry of HealthSlovenia: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Multiple Trauma
• Perioperative/Postoperative Complications
• Postoperative Complications
• Shock

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	Hyb, d.o.o., Slovenia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between wired and wireless invasive arterial blood pressure		24 hours of monitoring	Yes