The Diagnosis and Incidence of Critical Illness Polyneuromyopathy in Medical and Neurosurgical IC… (NCT02634658) | Clinical Trial Compass
CompletedNot Applicable
The Diagnosis and Incidence of Critical Illness Polyneuromyopathy in Medical and Neurosurgical ICU Patients
United States120 participantsStarted 2009-06
Plain-language summary
This study plans to learn more about whether simpler diagnostic tests can be used to identify the development of acute neuromuscular loss of function in patients with critical illness and respiratory failure receiving mechanical ventilation. ICU patients admitted to the University of Colorado Hospital will be screened for eligibility and enrollment in the study to receive weekly measurements of nerve and muscle function through nerve conduction studies (NCS), muscle ultrasound tests, and concentric needle electromyography (EMG) tests.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Acute respiratory failure defined as a Pa02 \< 60 mm Hg on room air, the requirement of supplemental oxygen, or a PaC02 \> 45 mm Hg.
✓. Admission to an intensive care unit.
✓. Mechanical ventilation support through an endotracheal tube for greater than 48 hours.
✓. Severe sepsis (suspected or documented infection + at least 2/4 SIRS criteria + organ dysfunction) or septic shock (sepsis plus hypotension refractory to intravenous fluids or plasma lactate \> 1.5 times the upper limit of normal)
✓. Acute respiratory failure defined as requiring invasive or non-invasive ventilation with a p/f ratio ≤ 250
✓. Admission to an intensive care unit, in ICU for greater than 48 hours.
✓. Plus dysfunction in one of the following organ systems:
✓. Cardiovascular dysfunction: (at least one of the following) i. SBP ≤ 90 mm Hg or MAP ≤ 70 mm Hg for at least one hour despite adequate fluid resuscitation. Adequate fluid resuscitation is defined as the patient receiving intravenous fluid resuscitation of ≥ 30 mL/kg administered at any time during the 4 hours before a hypotensive blood pressure.
Exclusion criteria
✕. Age less than 18 years.
✕. Diagnosis of pre-existing disease of the peripheral motor or sensory nervous system or myopathy.
✕. Central nervous system disorder that would compromise the ability of the patient to participate in the study.
What they're measuring
1
Aims 1.1-1.3: Number of medical ICU subjects diagnosed with CIPNM according to Moss/Quan established criteria of CIP or CIM.
Timeframe: Weekly up to Day 28 or hospital discharge whichever occurs first.
2
Aim 1.4: Number of neurosurgical ICU subjects diagnosed with CIPNM according to Moss/Quan established criteria of CIP or CIM.
Timeframe: Weekly through Day 28 or hospital discharge whichever occurs first