Variability Analysis as a Predictor of Liberation From Mechanical Ventilation

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. Identifier: NCT01140750
Recruitment Status : Completed
First Posted : June 9, 2010
Last Update Posted : June 9, 2010
Information provided by:
The Cleveland Clinic

Brief Summary:
The purpose of this study is to evaluate if the variability of biological signals, such as heart rate and temperature, can predict weaning from mechanical ventilation in patients with failure to wean.

Condition or disease
Mechanical Ventilation Autonomic Nervous System Diseases

Detailed Description:

Failure to wean is one of the most feared complications of mechanical ventilation. Prolonged mechanical ventilation occurs in 5-20% of all patients requiring MV in an intensive care unit. The published experience in the Cleveland Clinic in-hospital-weaning unit (ReSCU, Respiratory Special Care Unit) on long-term mechanical ventilation (>14 days) is that on average, 60% of the patients achieve complete ventilator independence.

The identification of factors that predict liberation from mechanical ventilation should improve outcomes and allocation of resources. Several attempts have been done to develop models to identify patients who will wean from prolonged MV; most rely on multiple measurements and their predictive ability is uncertain. Given the complexity of medical problems and the heterogeneity of the patients with prolonged MV, it is not unexpected that in order to achieve a good prediction, multiple variables are needed to encompass the whole population and relevant factors associated with the failure to wean.

Heart rate variability (HRV) is obtained from the measurement of the interval between successive heart beats; its analysis has been used extensively in cardiovascular disease. HRV is interpreted as a manifestation of the neurohumoral and autonomic system influence over the heart. Some researchers think that HRV relates to overall variability and is a manifestation of health in a complex biological system. Interpretation apart, multiple studies have demonstrated that the loss of variability reflects a poor prognosis overall. This phenomenon is seen not only in the heart, but also in breathing patterns, blood pressure, leukocyte count, electroencephalogram, gait, and recently in temperature. Limitations in interpretation and difficulty in acquisition (ventilator influence, respiratory rate influence, arrhythmias, medication) make HRV less practical in the mechanically ventilated population.

Surface temperature is not usually measured in clinical practice; it reflects skin thermoregulatory properties (where the autonomic system has a fundamental role). Recently, a novel marker to describe biological variability in body temperature has been studied. The temperature curve complexity (TCC) was used to predict mortality in critically ill patients. Its performance was comparable to that of scores like APACHE and SOFA, this has been described with HRV, hence suggesting a relation between TCC and HRV. Although no prior study has related TCC or HRV alone or to prolonged mechanical ventilation outcomes, there is reason to suspect that variability is decreased in ventilator-dependent patients.

In summary, the analysis of HRV and TCC has provided prognostic information in critically ill patients. A relation between HRV and TCC is expected but has not been described. Given the multiple influences of MV on HRV, TCC may be a better indicator of of variability in patients on MV. Our primary hypothesis is that the analysis of HRV and TCC will predict failure to wean from prolonged MV. Our secondary aims are: to identify the relationship between HRV and TCC, to describe the TCC in patients with prolonged MV, and to describe the changes in HRV and TCC in patients with successful and failed weaning.

This is an observational study in which measurements of HRV and TCC will be done in patients admitted to the ReSCU and compared to the ability to wean from mechanical ventilation.

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Variability Analysis as a Predictor of Liberation From Mechanical Ventilation in Patients Admitted to the Respiratory Special Care Unit (ReSCU)
Study Start Date : August 2007
Actual Study Completion Date : March 2008

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that were admitted to the Respiratory Special Care Unit (ReSCU)

Inclusion Criteria:

  • All patients being admitted to the Respiratory Special Care Unit (ReSCU) will be considered for this study.

Exclusion Criteria:

  • Current pregnancy
  • Age < 18 years old
  • No baseline temperature measurements
  • Second or greater admission to ReSCU
  • Patient refusal to participate in the study
  • Allergy to adhesive tape
  • Pacemaker or implanted electronic devices on the thorax

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01140750

United States, Ohio
Respiratory Special Care Unit, Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Principal Investigator: Eduardo Mireles-Cabodevila, MD The Cleveland Clinic
Study Director: James K Stoller, MD The Cleveland Clinic

Responsible Party: Sr Director Sponsored Research Administration, The Cleveland Clinic Foundation Identifier: NCT01140750     History of Changes
Other Study ID Numbers: IRB 07-283
First Posted: June 9, 2010    Key Record Dates
Last Update Posted: June 9, 2010
Last Verified: June 2010

Keywords provided by The Cleveland Clinic:
Heart Rate Variability
Temperature Curve Complexity
Autonomic Dysfunction
Prolonged Mechanical Ventilation
Failure to Wean

Additional relevant MeSH terms:
Nervous System Diseases
Autonomic Nervous System Diseases
Primary Dysautonomias