Clinical Investigation of Wireless Transmission of Invasive Blood Pressure Signal

This study has been completed.
Sponsor:
Collaborator:
Hyb, d.o.o., Slovenia
Information provided by:
University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT01373996
First received: June 10, 2011
Last updated: June 14, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Multiple Trauma
Shock
Atrial Fibrillation
Perioperative/Postoperative Complications
Device: Wireless invasive blood pressure monitoring (Hybymed® Wireless IBPM System)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Feasibility and Accuracy of Wireless Transmission of Invasive Blood Pressure Signal From Patient to Patient's Bedside Monitor

Resource links provided by NLM:


Further study details as provided by University Medical Centre Ljubljana:

Primary Outcome Measures:
  • Difference between wired and wireless invasive arterial blood pressure [ Time Frame: 24 hours of monitoring ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: June 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Hybymed® Wireless IBPM System HMW10. Hyb d.o.o., Slovenia
Wired
Measuring of invasive arterial blood pressure through conventional wired technology.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Critically ill patients

Criteria

Inclusion Criteria:

  • ICU patients requiring invasive blood pressure monitoring

Exclusion Criteria:

  • frequent blood sampling through arterial cannula (more than 3 times a day)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01373996

Sponsors and Collaborators
University Medical Centre Ljubljana
Hyb, d.o.o., Slovenia
Investigators
Principal Investigator: Primoz Gradisek, MD UMC Ljubljana
Principal Investigator: Neva Pozar-Lukanovic, MD, MMsc UMC Ljubljana
  More Information

No publications provided

Responsible Party: UMC Ljubljana (Primoz Gradisek), UMC Ljubljana
ClinicalTrials.gov Identifier: NCT01373996     History of Changes
Other Study ID Numbers: HMW10
Study First Received: June 10, 2011
Last Updated: June 14, 2011
Health Authority: Slovenia: Agency for Medicinal Products - Ministry of Health
Slovenia: Ethics Committee

Keywords provided by University Medical Centre Ljubljana:
Invasive blood pressure monitoring
Intensive care unit
Wireless Technology

Additional relevant MeSH terms:
Atrial Fibrillation
Multiple Trauma
Postoperative Complications
Shock
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Wounds and Injuries

ClinicalTrials.gov processed this record on August 28, 2014