We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Clinical Investigation of Wireless Transmission of Invasive Blood Pressure Signal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01373996
Recruitment Status : Completed
First Posted : June 15, 2011
Last Update Posted : June 15, 2011
Hyb, d.o.o., Slovenia
Information provided by:
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.

Condition or disease Intervention/treatment
Multiple Trauma Shock Atrial Fibrillation Perioperative/Postoperative Complications 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
Actual Enrollment : 12 participants
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
Study Start Date : June 2011
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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
Measuring of invasive arterial blood pressure through conventional wired technology.

Primary Outcome Measures :
  1. Difference between wired and wireless invasive arterial blood pressure [ Time Frame: 24 hours of monitoring ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Critically ill patients

Inclusion Criteria:

  • ICU patients requiring invasive blood pressure monitoring

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01373996

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

Responsible Party: UMC Ljubljana (Primoz Gradisek), UMC Ljubljana
ClinicalTrials.gov Identifier: NCT01373996     History of Changes
Other Study ID Numbers: HMW10
First Posted: June 15, 2011    Key Record Dates
Last Update Posted: June 15, 2011
Last Verified: April 2011

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

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