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Development of Algorithms to Predict Hemodynamic Instability

Development of Algorithms to Detect and Predict Hemodynamic Instability in Patients at Risk

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01262508
Enrollment
60
Registered
2010-12-17
Start date
2010-09-30
Completion date
2015-04-30
Last updated
2016-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sudden Cardiac Death

Keywords

autonomic nervous system

Brief summary

Hemodynamic monitoring in hospitalized patients is crucial since in clinical practice unexpected deterioration of cardiovascular function remains a serious problem and an important cause of death. Novel perspectives in reflex testing of the autonomic nervous system might be useful to protect some patients from cardiovascular events by detecting cardiovascular deteriorations. In addition, standard pulse oximetry in low acuity settings is nowadays predominately used to monitor peripheral oxygen saturation. Of note, there is evidence that additional analyses of pulse wave characteristics might be a valuable source of information to generate additional insights into the cardiorespiratory status of the patient. Herein, we aim to develop novel algorithms in order to protect in-hospital patients from cardiovascular events in consequence of hemodynamic instability in the future.

Detailed description

70 datasets from hospitalized patients will be acquired in order to characterize the functional status of the autonomic nervous system as well as hemodynamics during baseline and during standard procedures including physical exercise testing and head-up tilt table testing. Autonomic reflex testing: * Heart Rate Characteristics * Heart Rate Variability * Heart Rate Turbulence * Blood Pressure Variability * Baroreflex Sensitivity * Hyperoxic Chemoreflex Sensitivity Hemodynamic Monitoring: * Heart Rate Trends * Blood Pressure Trends * Pulse Wave Characteristics * Cardiac Output * Peripheral Vascular Resistance * Context information

Interventions

None listed

Sponsors

Klinik für Kardiologie, Pneumologie und Angiologie
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* hospitalization * Age \> 17 years

Exclusion criteria

* documented diseases of the central nervous system * impairment of mental health * age \> 85 years

Design outcomes

Primary

MeasureTime frameDescription
Autonomic Dysfunction24 hoursDysfunction of the autonomic nervous system as assessed by autonomic reflex testing

Secondary

MeasureTime frameDescription
Hemodynamic Deterioration24 hoursAcute hemodynamic changes (Blood pressure changes \> 10 mm Hg, heart rate changes \> 5 bpm both within 30 seconds) of a patient as assessed by hemodynamic monitoring

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026