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Electrocardiographic Autonomic Function Measures in Mechanically Ventilated Patients

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00844935
First received: February 13, 2009
Last updated: March 26, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition
Disorders of the Autonomic Nervous System
Cardiovascular Abnormalities
Respiratory Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: The Value of Electrocardiographic Autonomic Nervous System Function Measures for Predicting Cardiopulmonary Recovery of Mechanically Ventilated Patients in Intensive Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Enrollment: 0
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Mechanically ventilated patients in intensive care

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844935

Locations
United States, California
University of California, San Francisco Medical Center
San Francisco, California, United States, 94122
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Barbara Drew, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00844935     History of Changes
Other Study ID Numbers: H6052-33761-01
Study First Received: February 13, 2009
Last Updated: March 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
Heart rate variability, mechanical ventilation, weaning,
spontaneous breathing trial

Additional relevant MeSH terms:
Congenital Abnormalities
Autonomic Nervous System Diseases
Primary Dysautonomias
Respiration Disorders
 Respiratory Tract Diseases
Cardiovascular Abnormalities
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013