An observational study in Respiratory Insufficiency, sponsored by Unity Health Toronto. Completed at 1 site in Canada. Open to participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2018-04-10.
Sponsored by Unity Health Toronto · Observational
Mechanical ventilation is a life-saving treatment for critically ill patients who are unable to breathe on their own. At the time of recovery, separation from the ventilator is performed without difficulty for the majority of patients. However, approximately 15% of patients experience extubation failure, i.e. they are re-intubated after extubation within a period of 48 hours to 7 days. Patients who fail extubation are exposed to a longer duration of mechanical ventilation, higher rates of ventilator-acquired pneumonia, higher morbidity, and higher ICU mortality. Therefore, it is of relevant importance for clinicians to identify patients who are at risk of extubation failure as soon as ventilation has been discontinued. However, current clinical assessment has poor predictive performance: some physiological variables can be helpful but can only be obtained invasively using esophageal and gastric catheters.
Using ultrasound measurements to assess the activity of the respiratory muscles could be of particular interest for this purpose. By showing an early recruitment of the accessory muscles as well as diaphragm dysfunction or hyperactivity, ultrasounds could help clinicians pay greater attention to such patients and therefore try to apply specific therapeutics. There are several advantages to ultrasounds: they are non-invasive, available in most intensive care units, and previous studies have reported reasonable reliability of the measurements.
In the present study, we aim to assess the contractility of the respiratory muscles (diaphragm, intercostal, and sternocleidomastoid) using ultrasounds to identify patients who may be at risk of extubation failure and/or ICU readmission.
This study is a single centre, prospective, physiologic study in extubated patients (n = 110) to assess the contractility of the diaphragm, intercostal, and sternocleidomastoid muscles. The purpose is to determine whether employing ultrasounds early after extubation is a useful diagnostic tool to identify patients who may be at risk of extubation failure and/or intensive care unit (ICU) re-admission. The study will be performed in the Medical-Surgical ICU of St. Michael's Hospital.
Once the clinical team has decided to extubate the patient, the research team will approach the patient for consent (if capable) or the patient's substitute decision maker. Demographic information will be extracted from the medical chart and entered into the study case report form (CRF). Ultrasounds of the diaphragm, intercostal, and sternocleidomastoid muscles will be performed within 2 hours of extubation and repeated within 24 hours of extubation (if feasible). The following physiological and biological variables will be collected before and after the spontaneous breathing trial (SBT): mode of ventilation and settings, Arterial Blood Gas (ABG) results, heart rate, arterial blood pressure, peripheral capillary oxygen saturation (SpO2), respiratory rate, Glasgow Coma Score (GCS), temperature, fluid balance in the last 24 hours, Sequential Organ Failure Assessment (SOFA) score, and rapid shallow breathing index (RSBI). At the time of the ultrasound measurements, the following physiological variables will be collected: heart rate, arterial blood pressure, SpO2, respiratory rate, Glasgow Coma Score (GCS), cough, Intensive Care Delirium Screening Checklist (ICDSC), ambient air, oxygenation, use of non-invasive ventilation (NIV), level of dyspnea, level of comfort, nasal flaring, Medical Research Council (MRC) score, and the Respiratory Intensive Care Observation Scale (RICOS). Outcome data will be recorded including: extubation failure, use of NIV and/or high-flow nasal oxygen cannula post extubation, re-intubation, ICU discharge/re-admission status, and tracheostomy. A 7-day follow-up after ICU discharge will signify completion of the study.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 124 is above the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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Extubated ICU patients.
Exclusion Criteria:
Comparison of the thickening fraction of each muscle (diaphragm, intercostal, and sternocleidomastoid) between 2 groups of patients regarding the occurrence of extubation failure risk and ICU readmission.
Time frame: Up to 7 days after extubation
Plan to share: No
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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