NCT01140750

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2010

Completed
Last Updated

June 9, 2010

Status Verified

June 1, 2010

First QC Date

June 8, 2010

Last Update Submit

June 8, 2010

Conditions

Mechanical VentilationAutonomic Nervous System Diseases

Keywords

Heart Rate VariabilityTemperature Curve ComplexityAutonomic DysfunctionProlonged Mechanical VentilationFailure to Wean

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients that were admitted to the Respiratory Special Care Unit (ReSCU)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Respiratory Special Care Unit, Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (3)

  • 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.

    PMID: 16690981BACKGROUND

  • 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.

    PMID: 10453875BACKGROUND

  • 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.

    PMID: 12684315BACKGROUND

MeSH Terms

Conditions

Autonomic Nervous System DiseasesPrimary Dysautonomias

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

  • Eduardo Mireles-Cabodevila, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

  • James K Stoller, MD

    The Cleveland Clinic

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 8, 2010

First Posted

June 9, 2010

Study Start

August 1, 2007

Study Completion

March 1, 2008

Last Updated

June 9, 2010

Record last verified: 2010-06

Locations

US(1)