Hypovolemia/hypervolemia detection using peripheral intravenous waveform analysis (PIVA) and applications of same

A low blood volume, blood volume technology, applied in the field of hypovolemia and/or hypervolemia detection

Active Publication Date: 2017-08-01
VANDERBILT UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

More importantly, central venous monitoring does not provide survival benefit in critically ill patients[8][9]

Method used

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  • Hypovolemia/hypervolemia detection using peripheral intravenous waveform analysis (PIVA) and applications of same
  • Hypovolemia/hypervolemia detection using peripheral intravenous waveform analysis (PIVA) and applications of same
  • Hypovolemia/hypervolemia detection using peripheral intravenous waveform analysis (PIVA) and applications of same

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0113] Tested in the swine hemorrhage-resuscitation model

[0114] In this example, PIVA has been tested in a porcine hemorrhage-resuscitation model to study dynamic volume excursions under standardized settings. Using a non-invasive blood pressure cuff, 5-lead ECG, and pulse oximeter (SurgiVet, Norwell, Boston, MA) according to approved Institutional Animal Care and Use Committee protocols ) 8 adult Yorkshire pigs weighing 45 + / - 0.8 kg each were monitored non-invasively. Each animal was induced with general anesthesia with Telazol 2 mg, Ketamine 50 mg and Xylazine 2 mg administered via ear vein. After intubation with a cuffed 5.0 ID endotracheal tube, the pig was ventilated with a volume-controlled ventilator (Hallowell EMC, MA, USA) in volume-controlled mode with a tidal volume of 8 mL / kg and an end-tidal volume of 8 mL / kg. Positive pressure 5cm H 2 O, I:E ratio 1:2 and FiO 2 1.0. Titrate the respiratory rate (16-22 breaths / min) to maintain an end-tidal CO of 35-40 mm...

example 2

[0142] Tested in a controlled human bleeding model

[0143] In this example, PIVA was tested in a controlled human bleeding model to analyze dynamic changes in peripheral venous waveforms to assess volume status. The tests were approved by the Vanderbilt University Institutional Review Board (IRB) and written informed consent was obtained prior to surgery from selected patients scheduled for elective cardiac surgery. Any patient undergoing elective cardiac surgery met the inclusion criteria. Patients with a history of moderate or severe right ventricular dysfunction, severe anemia (hemoglobin <8 g / dl), or presenting arrhythmias or hemodynamic instability were excluded. A total of 12 patients were studied.

[0144] Anesthesia and Mechanical Ventilation

[0145] All patients were induced with opiates and propofol and received non-depolarizing neuromuscular blockade and thus had no signs of spontaneous breathing. All patients were intubated with an endotracheal tube and rec...

example 3

[0163] additional test

[0164] As shown in previous examples, the inventors have discovered that venous waveform analysis overcomes many of the key obstacles associated with arterial-based monitoring. The present inventors discovered and confirmed with tests that peripheral intravenous waveform analysis (PIVA) via pressure transducers in standard intravenous catheters detects bleeding in both human and porcine models.

[0165] The inventors performed an additional test on the blood loss PIVA assay in pigs: In this test, the PIVA device was administered to pigs (n=4) that had been intubated and sedated. All pigs were monitored in real time with intra-arterial blood pressure, heart rate, pulse oximeter and 5-lead electrocardiogram. The PIVA device was interfaced with LabChart (AD Instruments, Colorado Springs, CO, USA) software for continuous real-time data collection. Up to 15% of the blood volume was incrementally removed over a 20 minute period.

[0166] Figure 12 Shown...

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Abstract

Aspects of the invention relates to systems and methods for hypovolemia and / or hypervolemia detection of a living subject using peripheral intravenous waveform analysis. In one embodiment, the method includes: acquiring, from a vein of the living subject, peripheral venous signals; performing a spectral analysis on the acquired peripheral venous signals to obtain a peripheral venous pressure frequency spectrum; and performing a statistical analysis on amplitudes of peaks of the peripheral venous pressure frequency spectrum to determine the blood volume status of the living subject in real time. Specifically, at least two peaks, respectively corresponding to a first frequency and a second frequency, are obtained on the peripheral venous pressure frequency spectrum. Amplitude change of the second peak is used to determine the blood volume status of the living subject. Hemorrhage may be detected when a significant amplitude decrease is detected from the second baseline peak to the second peak.

Description

[0001] Cross References to Related Patent Applications [0002] This PCT application claims Susan S. Eagle, Colleen Brophy, Kyle Mitchell Hocking under 35 U.S.C. §119(e) ), Franz Baudenbacher, and Richard Boyer, submitted 12 September 2014 titled "A method for the harmonic analysis of peripheral venous pressure waveforms and its Priority and benefit of U.S. Provisional Patent Application No. 62 / 049,829 for METHOD FOR HARMONIC ANALYSISOF PERIPHERAL VENOUS PRESSURE WAVEFORMS AND APPLICATIONS OF SAME, the foregoing disclosure of which is incorporated herein by reference in its entirety. [0003] This PCT application also requests that Susan S. Eagle, Colleen Brophy, Kyle Mitchell Hawking, Franz Balderbach, and Richard Boyle file on September 14, 2015 The U.S. non-provisional application titled "HYPOVOLEMIA / HYPERVOLEMIA DETECTIONUSING PERIPHERAL INTRAVENOUS WAVEFORM ANALYSIS (PIVA) AND APPLICATIONS OFSAME" was filed on Priority and benefit to patent application Ser. No. 14 / 853,50...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61B5/02A61B5/0215
CPCA61B5/02042A61B5/02152
Inventor 苏珊·伊格尔科琳·布罗菲凯尔·霍金弗朗茨·波登巴彻理查德·波伊尔
Owner VANDERBILT UNIV
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