Monitoring Intercostal Muscles After Extubation

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.

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Key information

Conditions

Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Invasive mechanical ventilation ≥ 48 hours
Successful spontaneous breathing trial completed and extubation decided by the attending physician

Exclusion criteria

Withholding or withdrawal of life support
Patients under extracorporeal membrane oxygenation circuit
Impossibility to perform ultrasound of the diaphragm of the two accessory muscles: neck surgery, C-spine collar, Halo vest, morbid obesity. Patients will be enrolled as long as access to at least two locations is feasible (intercostal, diaphragm, or sternocleidomastoid).
Known (hemi) diaphragm paralysis

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Acronym: MIME

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Aug 2, 2016
Registry last updated: Apr 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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