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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. Pharmacologic paralysis.
. Absence of ability to test at least one arm and one leg with NCS/EMG (e.g. due to amputation or overlying equipment).
. Decremental response on repetitive nerve stimulation.