Electrocardiographic Autonomic Function Measures in Mechanically Ventilated Patients

NCT ID: NCT00844935

Last Updated: 2012-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-12-31

Brief Summary

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This research proposal has two main objectives. The first is to increase understanding of the underlying physiological interactions that occur between the cardiovascular, pulmonary, and ANS during transition between positive pressure mechanical ventilation (MV) and spontaneous breathing. The second is to determine if heart rate variability, (HRV) a reflection of autonomic nervous system (ANS) activity, and autonomic information flow (AIF), a set of nonlinear measures derived from HRV, both measured in the intensive care unit (ICU) can predict patient outcomes including successful weaning and in-hospital recovery time after an episode of cardiopulmonary compromise requiring MV.

Hypothesis 1. Transitions between mechanically supported ventilation and spontaneous breathing will disturb cardiovascular synchrony, altering the relationship of HRV, AIF, respiratory rate, and blood pressure;

Hypothesis 2. More normal HRV and AIF values, measured during baseline MV and sedation awakening (a period immediately prior to SBT when sedative medications are discontinued) will be associated with easier weaning, and shorter intensive care unit (ICU) and hospital lengths of stay; more abnormal measurements will be associated with longer lengths of stay;

Hypothesis 3. AIF is a more sensitive predictor of successful weaning from MV than HRV.

Detailed Description

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Conditions

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Disorders of the Autonomic Nervous System Cardiovascular Abnormalities Respiratory Disorders

Study Design

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Observational Model Type

COHORT

Eligibility Criteria

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Inclusion Criteria

* Receiving mechanical ventilation in medical-surgical intensive care unit;
* Eighteen years of age or older;
* Expectation of receiving initial spontaneous breathing trial within the next 24 hours.

Exclusion Criteria

* Pregnant;
* Expectation of non-survival when ventilator is discontinued;
* Cardiac rhythm of atrial fibrillation;
* Paced cardiac rhythm.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barbara Drew, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco Medical Center

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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H6052-33761-01

Identifier Type: -

Identifier Source: org_study_id

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