Variability Analysis During Weaning & Extubation in Critically Ill

Status Completed

Clinical 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). 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Critical Illness

Clinical Trial Details

NCT number	NCT01800448
Study type	Observational
Source	Ottawa Hospital Research Institute
Contact
Status	Completed
Phase	N/A
Start date	June 2012
Completion date	June 2013

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04551508` - Delirium Screening 3 Methods Study
Recruiting	`NCT06037928` - Plasma Sodium and Sodium Administration in the ICU
Completed	`NCT03671447` - Enhanced Recovery After Intensive Care (ERIC)	N/A
Recruiting	`NCT03941002` - Continuous Evaluation of Diaphragm Function	N/A
Recruiting	`NCT04674657` - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Completed	`NCT04239209` - Effect of Intensivist Communication on Surrogate Prognosis Interpretation	N/A
Completed	`NCT05531305` - Longitudinal Changes in Muscle Mass After Intensive Care	N/A
Terminated	`NCT03335124` - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock	Phase 4
Completed	`NCT02916004` - The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients.	N/A
Recruiting	`NCT05883137` - High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
Completed	`NCT04479254` - The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study)	N/A
Recruiting	`NCT04475666` - Replacing Protein Via Enteral Nutrition in Critically Ill Patients	N/A
Not yet recruiting	`NCT04538469` - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Not yet recruiting	`NCT04516395` - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae	N/A
Withdrawn	`NCT04043091` - Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction	N/A
Recruiting	`NCT02922998` - CD64 and Antibiotics in Human Sepsis	N/A
Recruiting	`NCT02989051` - Fluid Restriction Keeps Children Dry	Phase 2/Phase 3
Completed	`NCT03048487` - Protein Consumption in Critically Ill Patients
Completed	`NCT02899208` - Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients?	N/A
Recruiting	`NCT02163109` - Oxygen Consumption in Critical Illness

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Variability Analysis During Weaning and Extubation in Critically Ill Patients — NM3

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms