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Study of the Effect of Inhaled Anesthetics on Diastolic Heart Function Using a Doppler-derived Efficiency Index

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00907439
Recruitment Status : Completed
First Posted : May 22, 2009
Last Update Posted : November 5, 2010
Sponsor:
Information provided by:
Washington University School of Medicine

Tracking Information
First Submitted Date May 20, 2009
First Posted Date May 22, 2009
Last Update Posted Date November 5, 2010
Study Start Date November 2008
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 20, 2009)
Diastolic efficiency index (derived from the parameterized analysis of transmitral early filling Doppler using the paradigm of the ventricle as a damped harmonic oscillator) [ Time Frame: Following induction of volatile anesthesia ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 20, 2009)
Diastolic efficiency index (derived from the parameterized analysis of transmitral early filling Doppler using the paradigm of the ventricle as a damped harmonic oscillator) [ Time Frame: Following the onset of controlled ventilation ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of the Effect of Inhaled Anesthetics on Diastolic Heart Function Using a Doppler-derived Efficiency Index
Official Title Changes in Diastolic Dysfunction With the Onset of Volatile Anesthesia in Patients Undergoing Coronary Artery Bypass Grafting as Determined by a Load-independent Efficiency Index Derived From the Parameterized Doppler Analysis of Left Ventricular Filling
Brief Summary The purpose of this study is to determine the effect of inhaled anesthetic drugs upon diastolic heart function (heart suction and filling performance) in patients who are undergoing coronary bypass surgery.
Detailed Description Diastolic heart dysfunction is a significant cause of cardiovascular morbidity and is the cause of symptomatic heart failure in approximately one half of patients who are admitted to hospitals with heart failure symptoms. However, diastolic heart function remains difficult to measure objectively without cardiac catheterization. Diastolic heart dysfunction is also common among patients undergoing coronary bypass grafting (CABG) surgery. Despite the ubiquitous use of inhaled volatile drugs to maintain anesthesia in these patients, their effects upon diastolic heart function remain unclear.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients undergoing non-emergent coronary artery bypass grafting surgery at a tertiary care center
Condition
  • Diastolic Dysfunction
  • Coronary Artery Disease
  • General Anesthesia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 3, 2010)
21
Original Estimated Enrollment
 (submitted: May 20, 2009)
25
Actual Study Completion Date October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Non-emergent coronary bypass grafting surgery
  • Left ventricular ejection fraction of 40% or greater

Exclusion Criteria:

  • Myocardial infarction within 4 weeks
  • Greater than mild cardiac valvular pathology
  • Body mass index greater than 35
  • Cardiac dysrhythmias or pacemaker therapy
  • Left bundle branch block
  • Uncontrolled gastroesophageal reflux disease
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00907439
Other Study ID Numbers WU-HRPO-07-0551
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Troy Wildes, MD, Assistant Professor, Washington University School of Medicine, Department of Anesthesiology
Study Sponsor Washington University School of Medicine
Collaborators Not Provided
Investigators
Principal Investigator: Troy S Wildes, MD Washington University School of Medicine, Department of Anesthesiology
PRS Account Washington University School of Medicine
Verification Date November 2010