Electrocardiographic Autonomic Function Measures in Mechanically Ventilated Patients

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cardiovascular Abnormalities; Respiratory Disorders; Disorders of the Autonomic Nervous System

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94122
      • University of California, San Francisco Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Mechanically ventilated patients in intensive care

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Barbara Drew, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: February 13, 2009
• First Submitted That Met QC Criteria: February 13, 2009
• First Posted (Estimate): February 16, 2009

Study Record Updates

• Last Update Posted (Estimate): March 28, 2012
• Last Update Submitted That Met QC Criteria: March 26, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: spontaneous breathing trial; Heart rate variability, mechanical ventilation, weaning,
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Nervous System Diseases; Congenital Abnormalities; Disease; Cardiovascular Abnormalities; Respiration Disorders; Respiratory Tract Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases
• Other Study ID Numbers: H6052-33761-01