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CompletedNCT01140750Updated Jun 9, 2010

Variability Analysis as a Predictor of Liberation From Mechanical Ventilation

An observational study in Mechanical Ventilation and Autonomic Nervous System Diseases, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-06-09.

Sponsored by The Cleveland Clinic · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Mechanical Ventilation
  • Autonomic Nervous System Diseases

Keywords

  • Heart Rate Variability
  • Temperature Curve Complexity
  • Autonomic Dysfunction
  • Prolonged Mechanical Ventilation
  • Failure to Wean
03

In context

Nervous System Diseases

974 studies on the registry are indexed under Nervous System Diseases; 252 are open to participants now.

This study's planned enrollment of 30 is below the median of 127 across 318 observational studies indexed under Nervous System Diseases.

Browse Nervous System Diseases studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 819 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
30 participants (estimated)
06

Study locations

1 site
  • Respiratory Special Care Unit, Cleveland Clinic
    Cleveland, Ohio 44195, United States
07

References and documents

Publications

  • Varela M, Churruca J, Gonzalez A, Martin A, Ode J, Galdos P. Temperature curve complexity predicts survival in critically ill patients. Am J Respir Crit Care Med. 2006 Aug 1;174(3):290-8. doi: 10.1164/rccm.200601-058OC. Epub 2006 May 11. PubMed 16690981 ↗
  • Dasgupta A, Rice R, Mascha E, Litaker D, Stoller JK. Four-year experience with a unit for long-term ventilation (respiratory special care unit) at the Cleveland Clinic Foundation. Chest. 1999 Aug;116(2):447-55. doi: 10.1378/chest.116.2.447. PubMed 10453875 ↗
  • Shen HN, Lin LY, Chen KY, Kuo PH, Yu CJ, Wu HD, Yang PC. Changes of heart rate variability during ventilator weaning. Chest. 2003 Apr;123(4):1222-8. doi: 10.1378/chest.123.4.1222. PubMed 12684315 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01140750
Lead sponsor
The Cleveland Clinic
First posted
Jun 9, 2010
Start date
Aug 2007
Completion
Mar 2008
Last update
Jun 9, 2010

Study contacts

Eduardo Mireles-Cabodevila, MD
principal investigator · The Cleveland Clinic
James K Stoller, MD
study director · The Cleveland Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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