Critical IllnessNM3NCT01800448
Variability Analysis During Weaning and Extubation in Critically Ill Patients
An observational study of Critical Illness, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
For critically ill patients, it is important to know when to liberate them from mechanical ventilation (the removal of breathing or endotracheal tube or extubation) and weaning (the progressive decrease of the amount of support that a patient receives from the mechanical ventilation). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to Jun 2013
- 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: ICU Patients
Who may be able to join
- Respiratory failure
- Cardiac failure
- Consent within 48 hours of admission to the ICU
Who cannot join
- Allergy to skin adhesives
- On study less than 72 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiopulmonary Monitoring, Skin Conductance and Variability Analysis During Weaning and Extubation in Critically Ill Patients
For critically ill patients, it is important to know when to liberate them from mechanical ventilation (the removal of breathing or endotracheal tube or extubation) and weaning (the progressive decrease of the amount of support that a patient receives from the mechanical ventilation). It is well recognized that prolonged ventilation and weaning harms patients and introduces significant increased costs to the health care system. The investigators objective is to improve the safety of removal of life support in critically ill patients by harnessing information from two new technologies; NM3 and Nexus device. In particular, the investigators are interested in the patterns of variation of respiratory and cardiac signals from the NM3 device, as well as monitor skin conductance with the Nexus device. The combination of these measures has not yet been investigated to date, and could represent a novel set of measures that can be used to help physicians better manage critically ill patients. The current standard of care dictates that once a patient is considered as a candidate for withdrawal from ventilation, a spontaneous breathing trial (SBTs) is performed, where the degree of ventilator support is decreased, and their response is observed to help predict if they will tolerate extubation.
Health is associated with a high degree of variation of physiologic parameters such as heart rate and respiratory rate, and illness \& stress are associated with a loss of variability. The analysis of variability of biological signals measures the degree of fluctuations present over time. Previous studies have demonstrated that changes in variability (generally decreases) are observed in illness states, and the degree of this change correlates with illness severity. Several studies have reported that reduced heart or respiratory rate variability (HRV or RRV) during SBTs is associated with extubation failure. Until recently, variability analysis has traditionally been done only on heart rate (HRV), derived from analyzing beat-to-beat intervals from the ubiquitous electrocardiogram (ECG). The investigators aim to apply variability analysis to the respiratory and cardiac signals which represent a rich novel set of muti-organ variability measures whose utility in managing extubation and ventilator weaning has not been investigated to date.
- Conditions
- Critical Illness
- Keywords
- Respiratory monitoring, cardiac monitoring, skin conductance monitoring, variability
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing respiratory monitoring
looking at the variability of measures of respiratory function that are normally taken during an ICU stay
Measured: consent to 5 days after extubation
Ongoing cardiac monitoring
looking at the variability of measures of cardiac function that are normally taken during an ICU stay
Measured: consent to 5 days after extubation
Ongoing skin conductance monitoring
looking at skin conductance during the ICU stay
Measured: consent to 5 days after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startJun 2012
- Primary completionSep 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Respironics, California, Inc., Therapeutic Monitoring Systems
- Responsible party
- Sponsor
- Investigators
- Gwynne Jones, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800448
- Sponsor's protocol ID
- 2011763-01H
- Acronym
- NM3
- Status last verified
- Jul 2017
- First submitted
- 12 Oct 2012
- Last updated
- 7 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Monitoring, Skin Conductance and Variability Analysis During Weaning and Extubation in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01800448
- Acronym / sponsor ID
- NM3 / 2011763-01H
- Conditions
- Critical Illness
- Keywords
- Respiratory monitoring, cardiac monitoring, skin conductance monitoring, variability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Respironics, California, Inc., Therapeutic Monitoring Systems
- Study start
- Jun 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Feb 2013 (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.
For critically ill patients, it is important to know when to liberate them from mechanical ventilation (the removal of breathing or endotracheal tube or extubation) and weaning (the progressive decrease of the amount of support that a patient receives from the mechanical ventilation). It is well recognized that prolonged ventilation and weaning harms patients and introduces significant increased costs to the health care system. The investigators objective is to improve the safety of removal of life support in critically ill patients by harnessing information from two new technologies; NM3 and Nexus device. In particular, the investigators are interested in the patterns of variation of respiratory and cardiac signals from the NM3 device, as well as monitor skin conductance with the Nexus device. The combination of these measures has not yet been investigated to date, and could represent a novel set of measures that can be used to help physicians better manage critically ill patients. The current standard of care dictates that once a patient is considered as a candidate for withdrawal from ventilation, a spontaneous breathing trial (SBTs) is performed, where the degree of ventilator support is decreased, and their response is observed to help predict if they will tolerate extubation.
Health is associated with a high degree of variation of physiologic parameters such as heart rate and respiratory rate, and illness \& stress are associated with a loss of variability. The analysis of variability of biological signals measures the degree of fluctuations present over time. Previous studies have demonstrated that changes in variability (generally decreases) are observed in illness states, and the degree of this change correlates with illness severity. Several studies have reported that reduced heart or respiratory rate variability (HRV or RRV) during SBTs is associated with extubation failure. Until recently, variability analysis has traditionally been done only on heart rate (HRV), derived from analyzing beat-to-beat intervals from the ubiquitous electrocardiogram (ECG). The investigators aim to apply variability analysis to the respiratory and cardiac signals which represent a rich novel set of muti-organ variability measures whose utility in managing extubation and ventilator weaning has not been investigated to date.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU Patients
Key inclusion criteria (3 listed)
- Respiratory failure
- Cardiac failure
- Consent within 48 hours of admission to the ICU
Key exclusion criteria (2 listed)
- Allergy to skin adhesives
- On study less than 72 hours
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
Ongoing respiratory monitoring
Time frame: consent to 5 days after extubation
looking at the variability of measures of respiratory function that are normally taken during an ICU stay
Ongoing cardiac monitoring
Time frame: consent to 5 days after extubation
looking at the variability of measures of cardiac function that are normally taken during an ICU stay
Ongoing skin conductance monitoring
Time frame: consent to 5 days after extubation
looking at skin conductance during the ICU stay
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 7 Jul 2017.
Related trials for Critical Illness
Active, not recruiting
PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
Critical Illness
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Active, not recruitingObservational study
Adverse Events During Physical Therapy in Neurocritical ICU Patients
Critical Illness, Brain Injury
Recruiting
Effectiveness of Virtual Reality in Improving Upper Limb Function in Critically Ill Patients
Intensive Care Unit (ICU) Acquired Weakness (ICU - AW), Critical Illness
RecruitingObservational study
Metabolic and Functional Study of γδ T Cells in Critically Ill Patients
Sepsis, Critical Illness
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.
Gwynne Jones, MD principal investigator
Ottawa Hospital Research Institute
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 Critical Illness, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 3 inclusion and 2 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 7 Jul 2017. 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 Canada. 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.
What does the primary outcome measure?
Ongoing respiratory monitoring (time frame: consent to 5 days after extubation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2017; AzTrials last refreshed its copy on 31 Oct 2026.