Mechanical VentilationNCT01140750
Variability Analysis as a Predictor of Liberation From Mechanical Ventilation
An observational study of Mechanical Ventilation and Autonomic Nervous System Diseases, run by The Cleveland Clinic at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Autonomic Nervous System Diseases
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that were admitted to the Respiratory Special Care Unit (ReSCU)
Who may be able to join
- All patients being admitted to the Respiratory Special Care Unit (ReSCU) will be considered for this study.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Respiratory Special Care Unit, Cleveland Clinic
Cleveland, Ohio, 44195
About this study
Official title: Variability Analysis as a Predictor of Liberation From Mechanical Ventilation in Patients Admitted to the Respiratory Special Care Unit (ReSCU)
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.
- Keywords
- Heart Rate Variability, Temperature Curve Complexity, Autonomic Dysfunction, Prolonged Mechanical Ventilation, Failure to Wean
- Medical subject headings
- Autonomic Nervous System Diseases, Primary Dysautonomias
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startAug 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Eduardo Mireles-Cabodevila, MD, Principal investigator, The Cleveland ClinicJames K Stoller, MD, Study director, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140750
- Sponsor's protocol ID
- IRB 07-283
- Status last verified
- Jun 2010
- First submitted
- 8 Jun 2010
- Last updated
- 9 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
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 16690981Dasgupta 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 10453875Shen 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variability Analysis as a Predictor of Liberation From Mechanical Ventilation in Patients Admitted to the Respiratory Special Care Unit (ReSCU)
- ClinicalTrials.gov ID
- NCT01140750
- Acronym / sponsor ID
- IRB 07-283
- Keywords
- Heart Rate Variability, Temperature Curve Complexity, Autonomic Dysfunction, Prolonged Mechanical Ventilation, Failure to Wean
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Aug 2007
- Study completion
- Mar 2008 (actual)
- First posted
- 9 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that were admitted to the Respiratory Special Care Unit (ReSCU)
Key inclusion criteria (1 listed)
- All patients being admitted to the Respiratory Special Care Unit (ReSCU) will be considered for this study.
Key exclusion criteria (7 listed)
- Current pregnancy
- Age < 18 years old
- No baseline temperature measurements
- Second or greater admission to ReSCU
- Patient refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2010.
- Background: PubMed 16690981Varela 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.
- Background: PubMed 10453875Dasgupta 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.
- Background: PubMed 12684315Shen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Mireles-Cabodevila, MD principal investigator
The Cleveland Clinic
James K Stoller, MD study director
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation and Autonomic Nervous System Diseases, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01140750, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2010.