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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01262508
Other study ID # Autonomics - Prediction
Secondary ID
Status Completed
Phase N/A
First received December 16, 2010
Last updated February 18, 2016
Start date September 2010
Est. completion date April 2015

Study information

Verified date February 2016
Source Heinrich-Heine University, Duesseldorf
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- hospitalization

- Age > 17 years

Exclusion Criteria:

- documented diseases of the central nervous system

- impairment of mental health

- age > 85 years

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Heinrich-Heine-University Duesseldorf NRW

Sponsors (1)

Lead Sponsor Collaborator
Klinik für Kardiologie, Pneumologie und Angiologie

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Autonomic Dysfunction Dysfunction of the autonomic nervous system as assessed by autonomic reflex testing 24 hours No
Secondary Hemodynamic Deterioration Acute 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 24 hours No
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