Variability Analysis During Weaning and Extubation in Critically Ill Patients

NCT01800448 | Completed

• 1 other identifier: 2011763-01H
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (3)

• Ongoing respiratory monitoring

  looking at the variability of measures of respiratory function that are normally taken during an ICU stay

  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

  consent to 5 days after extubation

• Ongoing skin conductance monitoring

  looking at skin conductance during the ICU stay

  consent to 5 days after extubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU Patients

You may qualify if:

• Respiratory failure
• Cardiac failure
• Consent within 48 hours of admission to the ICU

You may not qualify if:

• Allergy to skin adhesives
• On study less than 72 hours

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Respironics, California, Inc.: collaborator
• Therapeutic Monitoring Systems: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gwynne Jones, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2012
• First Posted: February 27, 2013
• Study Start: June 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: June 1, 2013
• Last Updated: July 7, 2017

Record last verified: 2017-07

Locations

CA (1)