Electrocardiographic Autonomic Function Measures in Mechanically Ventilated Patients

Cardiovascular Abnormalities Clinical Trial

Official title:

The Value of Electrocardiographic Autonomic Nervous System Function Measures for Predicting Cardiopulmonary Recovery of Mechanically Ventilated Patients in Intensive Care

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00844935
• Other study ID #: H6052-33761-01
• Status: Withdrawn
• Phase: N/A
• First received: February 13, 2009
• Last updated: March 26, 2012
• Start date: September 2011
• Est. completion date: December 2012

Study information

• Verified date: March 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Autonomic Nervous System Diseases
• Cardiovascular Abnormalities
• Disease
• Disorders of the Autonomic Nervous System
• Primary Dysautonomias
• Respiration Disorders
• Respiratory Disorders
• Respiratory Tract Diseases

Locations

Country	Name	City	State
United States	University of California, San Francisco Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States,