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
|Condition or disease||Intervention/treatment|
|Multiple Trauma Shock Atrial Fibrillation Perioperative/Postoperative Complications||Device: Wireless invasive blood pressure monitoring (Hybymed® Wireless IBPM System)|
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|
|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|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
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.
- Difference between wired and wireless invasive arterial blood pressure [ Time Frame: 24 hours of monitoring ]
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
|Principal Investigator:||Primoz Gradisek, MD||UMC Ljubljana|
|Principal Investigator:||Neva Pozar-Lukanovic, MD, MMsc||UMC Ljubljana|