Critical IllnessNCT02634658
The Diagnosis and Incidence of Critical Illness Polyneuromyopathy in Medical and Neurosurgical ICU Patients
A study testing Muscle Ultrasound, Nerve Conduction Study and Electromyography in people with Critical Illness, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Muscle Ultrasound, Nerve Conduction Study and Electromyography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Aim 1.1-1.3, one of the following 2 sets of criteria are needed for inclusion
- Set 1:
- 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)
Show all 19Show fewer
- Set 2:
- 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.
- The use of vasopressors in an attempt to maintain a SBP of ≥ 90 mm Hg or a MAP of ≥ 65 mm Hg despite adequate intravascular volume status. Adequate intravascular volume status is defined as intravenous fluid resuscitation of ≥ 30 mL/kg administered at any time during the 4 hours before or after initiation of vasopressor therapy. Vasopressive therapy is defined as any one of the following: Norepinephrine, Phenylephrine, Epinephrine, Dopamine ≥ 5 mcg/kg/min, or Vasopressin ≥ 0.03 units/min.
- Kidney dysfunction: Urine output < 0.5 ml/kg of body weight/hr for 1 hour despite adequate fluid resuscitation or adequate intravascular volume status (as defined above)
- Hematologic dysfunction: Platelet count < 80,000 or a decrease by 50% over the previous 3 days.
- Acidosis: (at least one of the following) i. pH ≤ 7.30 ii. Plasma lactate > 1.5 times the upper limit of normal
- For Aim 1.4, all of the following criteria are needed for inclusion.
- Non-traumatic subarachnoid hemorrhage or intracerebral (intraparenchymal) hemorrhage.
- Admission to a neurological or neurosurgical intensive care unit.
- Mechanical ventilation support through an endotracheal tube for greater than 48 hours.
Who cannot join
- For Aim 1.1-1.3:
- 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).
Show all 25Show fewer
- Decremental response on repetitive nerve stimulation.
- External pacemaker wire.
- Pregnancy.
- Initiation of mechanical ventilation (invasive or non-invasive) and admission to the ICU both >120 hours (5 days) ago.
- Referral from another hospital for patients that have required mechanical ventilation for more than 48 hours.
- Inability to obtain informed consent or refusal to participate in the study.
- Known steroid-induced myopathy prior to ICU admission resulting from chronic systemic glucocorticoid therapy.
- For Aim 1.4:
- Isolated subdural or epidural hematoma
- Age less than 18 years.
- Diagnosis of pre-existing disease of the peripheral motor or sensory nervous system or myopathy.
- 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.
- External pacemaker wire.
- Pregnancy.
- Initiation of mechanical ventilation and admission to the ICU both >120 hours (5 days) ago.
- Referral from another hospital for patients that have required mechanical ventilation for more than 48 hours.
- Inability to obtain informed consent or refusal to participate in the study. Known steroid-induced myopathy prior to ICU admission resulting from chronic systemic glucocorticoid therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
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.
Read the detailed description
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.
Collected data includes the subject's age, gender, race, ethnicity, length of stay in ICU, time on mechanical ventilation and pertinent medical history that could indicate baseline neuromyopathy (CNS disease, diabetes, HIV, alcohol use disorder). Baseline neurological examination will be performed within 48 hours of meeting the inclusion criteria. This examination will include the level of consciousness, muscle tone, motor strength using the Medical Research Council (MRC) Scale, sensory function, muscle stretch reflexes, and plantar responses. For MRC testing, six muscle groups will be tested bilaterally: shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and foot dorsiflexion. Clinical weakness on examination (which is necessary to make the diagnosis of CIPNM (Critical Illness Polyneuropathy and Myopathy)) is defined as an MRC score equal to or less than 48 (maximum score is 60). If a subject cannot participate in any MRC strength testing (e.g. due to sedation or encephalopathy) they will be coded at the lowest level (most severe clinical weakness). Nerve conduction studies (NCS) and concentric needle electromyography (EMG) will be performed (as described below) on the same day as the initial neurological examination. The neurological examination and NCS/EMG will be repeated on a weekly basis until CIPNM is diagnosed or the subject is discharged from the ICU.
SPECIFIC AIM #1:
Aim 1.1: To determine whether amplitude reductions in the peroneal and sural nerve action potentials on NCS can serve as accurate screening tests for CIPNM in patients with acute respiratory failure.
Aim 1.2: To determine whether increased duration of the CMAP on NCS can serve as an accurate screening test for CIPNM in patients with acute respiratory failure.
Aim 1.3: To determine whether changes in muscle ultrasound echogenicity and/or thickness can serve as accurate screening tests for CIPNM in patients with acute respiratory failure.
Aim 1.4: To determine the incidence of CIPNM in patients with neurological critical illness (such as intraparenchymal and subarachnoid hemorrhage), which requires prolonged length of stay in a neurosurgical intensive care unit.
- Conditions
- Critical Illness
- Being tested
- Muscle Ultrasound, Nerve Conduction Study, Electromyography
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle UltrasoundOther
Also called US, Ultrasound
Ultrasound will be performed using a linear-array transducer with standardized gain and varying depth based on the amount of overlying soft tissue and muscle size. The subjects will be examined in the supine position with extended limbs and relaxed muscles. We will perform bilateral scans of the biceps, anterior forearm, and anterior thigh at standardized sites. For muscle echogenicity measurements, we will scan the same muscles at the same points.
Nerve Conduction StudyOther
Also called NCS
Nerve Conduction Studies will be performed using a Nicolet EDX using standard procedures. Repetitive stimulation of the median motor nerve are performed in all subjects. Bilateral sural, radial and median sensory nerves will be analyzed. We will only perform surface, not subdermal sensory recordings. The bilateral peroneal, tibial and median motor responses will be recorded over extensor digitorum brevis, abductor hallucis brevis, and abductor pollicis brevis muscles. The peroneal motor nerve will be stimulated at the fibular head and lateral popliteal fossa, recording from the tibialis anterior muscle. The compound motor action potential (CMAP) responses will be elicited from standard distal and proximal sites.
ElectromyographyOther
Also called EMG
EMG studies will be performed using standard precautions. Insertional activity, spontaneous activity, motor unit potential (MUP) morphology and recruitment/activation pattern will be recorded from some combination of the deltoid, triceps, biceps, first dorsal interosseous, abductor pollicis brevis, iliopsoas, vastus medialis, and tibialis anterior muscles. The specific muscles studied for each patient will vary according to the patient's level of consciousness and ability to activate the muscles either voluntarily or during spontaneous limb movement. If possible, we will try to examine 3 unilateral upper extremity and 3 unilateral lower extremity muscles. If a patient is not able to volitionally participate in EMG testing (by contracting their muscles on command), we will analyze insertional/spontaneous activity and potentially morphology/recruitment (e.g. stroking the sole of the foot to stimulate contraction of the tibialis anterior).
| Study group | Role | What they receive |
|---|---|---|
| Medical ICU Subjects | Experimental | All Medical ICU subjects that meet eligibility criteria and are enrolled in the study will receive muscle Ultrasounds, Nerve Conduction Studies and Electromyography (EMG). Receives: Other: Muscle Ultrasound; Other: Nerve Conduction Study; Other: Electromyography |
| Neuro ICU Subjects | Experimental | All Neuro ICU subjects that meet eligibility criteria and are enrolled in the study will receive Nerve Conduction Studies and Electromyography (EMG). Receives: Other: Nerve Conduction Study; Other: Electromyography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aims 1.1-1.3: Number of medical ICU subjects diagnosed with CIPNM according to Moss/Quan established criteria of CIP or CIM.
Subjects have CIPNM if either Moss/Quan criteria for (CIP) or (CIM) criteria are met:
CIP:
SNAP amplitudes < 80% of lower norm limit of 2+ nerves, Reduced recruitment on EMG, Absence of decremental response, and MRC score < 48 or clinical weakness on exam
CIM:
SNAP amplitudes > 80% of the lower norm limit of 2+ nerves, CMAP amplitudes < 80% of the lower limit of normal in two or more nerves without conduction block, needle EMG with short-duration, low amplitude motor unit potentials with early recruitment, absence of a decremental response, and MRC score < 48 or clinical weakness on exam
CIPNM:
Absence of a decremental response, SNAP amplitudes < 80% of the lower limit of normal in two or more nerves, CMAP amplitudes < 80% of the lower limit of normal in two or more nerves without conduction block, sustained spontaneous activity and/or changes in motor unit recruitment, in at least two muscles, and MRC score < 48 or clinical weakness on exam
Measured: Weekly up to Day 28 or hospital discharge whichever occurs first.
Aim 1.4: Number of neurosurgical ICU subjects diagnosed with CIPNM according to Moss/Quan established criteria of CIP or CIM.
Subjects have CIPNM if either Moss/Quan criteria for (CIP) or (CIM) criteria are met:
CIP:
SNAP amplitudes < 80% of lower norm limit of 2+ nerves, Reduced recruitment on EMG, Absence of decremental response, and MRC score < 48 or clinical weakness on exam
CIM:
SNAP amplitudes > 80% of the lower norm limit of 2+ nerves, CMAP amplitudes < 80% of the lower limit of normal in two or more nerves without conduction block, needle EMG with short-duration, low amplitude motor unit potentials with early recruitment, absence of a decremental response, and MRC score < 48 or clinical weakness on exam
CIPNM:
Absence of a decremental response, SNAP amplitudes < 80% of the lower limit of normal in two or more nerves, CMAP amplitudes < 80% of the lower limit of normal in two or more nerves without conduction block, sustained spontaneous activity and/or changes in motor unit recruitment, in at least two muscles, and MRC score < 48 or clinical weakness on exam
Measured: Weekly through Day 28 or hospital discharge whichever occurs first
Secondary outcomes (7)
ICU length of stay
ICU length of stay
Measured: upon completion of ICU stay, commonly 7-14 days.
ICU-free days
the number of days out of 28 that the subject is alive and out of the ICU, but remains hospitalized.
Measured: upon completion of inpatient period, commonly up to 28 days.
time on mechanical ventilation
time on mechanical ventilation
Measured: upon completion of ventilation period, commonly 3-14 days.
hospital length of stay
hospital total length of subject stay.
Measured: upon completion of inpatient period, commonly up to 28 days.
hospital-free days
the number of days oout of 28 that the subject was alive and out of the acute care hospital.
Measured: 28 days
in hospital mortality
Incidence of in hospital mortality through day 28
Measured: 28 days
Discharge location
Subject discharge location from acute hospitalization period to home, SNF, rehab hospital, LTACH, hospice, etc.
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startJun 2009
- Primary completionApr 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Moss, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634658
- Sponsor's protocol ID
- 15-1557
- Status last verified
- May 2017
- First submitted
- 13 Nov 2015
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnosis and Incidence of Critical Illness Polyneuromyopathy in Medical and Neurosurgical ICU Patients
- ClinicalTrials.gov ID
- NCT02634658
- Acronym / sponsor ID
- 15-1557
- Conditions
- Critical Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 18 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Collected data includes the subject's age, gender, race, ethnicity, length of stay in ICU, time on mechanical ventilation and pertinent medical history that could indicate baseline neuromyopathy (CNS disease, diabetes, HIV, alcohol use disorder). Baseline neurological examination will be performed within 48 hours of meeting the inclusion criteria. This examination will include the level of consciousness, muscle tone, motor strength using the Medical Research Council (MRC) Scale, sensory function, muscle stretch reflexes, and plantar responses. For MRC testing, six muscle groups will be tested bilaterally: shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and foot dorsiflexion. Clinical weakness on examination (which is necessary to make the diagnosis of CIPNM (Critical Illness Polyneuropathy and Myopathy)) is defined as an MRC score equal to or less than 48 (maximum score is 60). If a subject cannot participate in any MRC strength testing (e.g. due to sedation or encephalopathy) they will be coded at the lowest level (most severe clinical weakness). Nerve conduction studies (NCS) and concentric needle electromyography (EMG) will be performed (as described below) on the same day as the initial neurological examination. The neurological examination and NCS/EMG will be repeated on a weekly basis until CIPNM is diagnosed or the subject is discharged from the ICU.
SPECIFIC AIM #1:
Aim 1.1: To determine whether amplitude reductions in the peroneal and sural nerve action potentials on NCS can serve as accurate screening tests for CIPNM in patients with acute respiratory failure.
Aim 1.2: To determine whether increased duration of the CMAP on NCS can serve as an accurate screening test for CIPNM in patients with acute respiratory failure.
Aim 1.3: To determine whether changes in muscle ultrasound echogenicity and/or thickness can serve as accurate screening tests for CIPNM in patients with acute respiratory failure.
Aim 1.4: To determine the incidence of CIPNM in patients with neurological critical illness (such as intraparenchymal and subarachnoid hemorrhage), which requires prolonged length of stay in a neurosurgical intensive care unit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical ICU Subjects | Experimental | Other: Muscle Ultrasound, Other: Nerve Conduction Study, Other: ElectromyographyAll Medical ICU subjects that meet eligibility criteria and are enrolled in the study will receive muscle Ultrasounds, Nerve Conduction Studies and Electromyography (EMG). |
| Neuro ICU Subjects | Experimental | Other: Nerve Conduction Study, Other: ElectromyographyAll Neuro ICU subjects that meet eligibility criteria and are enrolled in the study will receive Nerve Conduction Studies and Electromyography (EMG). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- For Aim 1.1-1.3, one of the following 2 sets of criteria are needed for inclusion
- 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)
Key exclusion criteria (25 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle UltrasoundAlso: US, UltrasoundUltrasound will be performed using a linear-array transducer with standardized gain and varying depth based on the amount of overlying soft tissue and muscle size. The subjects will be examined in the supine position with extended limbs and relaxed muscles. We will perform bilateral scans of the biceps, anterior forearm, and anterior thigh at standardized sites. For muscle echogenicity measurements, we will scan the same muscles at the same points. | Other | Medical ICU Subjects |
| Nerve Conduction StudyAlso: NCSNerve Conduction Studies will be performed using a Nicolet EDX using standard procedures. Repetitive stimulation of the median motor nerve are performed in all subjects. Bilateral sural, radial and median sensory nerves will be analyzed. We will only perform surface, not subdermal sensory recordings. The bilateral peroneal, tibial and median motor responses will be recorded over extensor digitorum brevis, abductor hallucis brevis, and abductor pollicis brevis muscles. The peroneal motor nerve will be stimulated at the fibular head and lateral popliteal fossa, recording from the tibialis anterior muscle. The compound motor action potential (CMAP) responses will be elicited from standard distal and proximal sites. | Other | Medical ICU Subjects, Neuro ICU Subjects |
| ElectromyographyAlso: EMGEMG studies will be performed using standard precautions. Insertional activity, spontaneous activity, motor unit potential (MUP) morphology and recruitment/activation pattern will be recorded from some combination of the deltoid, triceps, biceps, first dorsal interosseous, abductor pollicis brevis, iliopsoas, vastus medialis, and tibialis anterior muscles. The specific muscles studied for each patient will vary according to the patient's level of consciousness and ability to activate the muscles either voluntarily or during spontaneous limb movement. If possible, we will try to examine 3 unilateral upper extremity and 3 unilateral lower extremity muscles. If a patient is not able to volitionally participate in EMG testing (by contracting their muscles on command), we will analyze insertional/spontaneous activity and potentially morphology/recruitment (e.g. stroking the sole of the foot to stimulate contraction of the tibialis anterior). | Other | Medical ICU Subjects, Neuro ICU Subjects |
Primary outcome
Aims 1.1-1.3: Number of medical ICU subjects diagnosed with CIPNM according to Moss/Quan established criteria of CIP or CIM.
Time frame: Weekly up to Day 28 or hospital discharge whichever occurs first.
Subjects have CIPNM if either Moss/Quan criteria for (CIP) or (CIM) criteria are met: CIP: SNAP amplitudes < 80% of lower norm limit of 2+ nerves, Reduced recruitment on EMG, Absence of decremental response, and MRC score < 48 or clinical weakness on exam CIM: SNAP amplitudes > 80% of the lower norm limit of 2+ nerves, CMAP amplitudes < 80% of the lower limit of normal in two or more nerves without conduction block, needle EMG with short-duration, low amplitude motor unit potentials with early recruitment, absence of a decremental response, and MRC score < 48 or clinical weakness on exam CIPNM: Absence of a decremental response, SNAP amplitudes < 80% of the lower limit of normal in two or more nerves, CMAP amplitudes < 80% of the lower limit of normal in two or more nerves without conduction block, sustained spontaneous activity and/or changes in motor unit recruitment, in at least two muscles, and MRC score < 48 or clinical weakness on exam
Aim 1.4: Number of neurosurgical ICU subjects diagnosed with CIPNM according to Moss/Quan established criteria of CIP or CIM.
Time frame: Weekly through Day 28 or hospital discharge whichever occurs first
Subjects have CIPNM if either Moss/Quan criteria for (CIP) or (CIM) criteria are met: CIP: SNAP amplitudes < 80% of lower norm limit of 2+ nerves, Reduced recruitment on EMG, Absence of decremental response, and MRC score < 48 or clinical weakness on exam CIM: SNAP amplitudes > 80% of the lower norm limit of 2+ nerves, CMAP amplitudes < 80% of the lower limit of normal in two or more nerves without conduction block, needle EMG with short-duration, low amplitude motor unit potentials with early recruitment, absence of a decremental response, and MRC score < 48 or clinical weakness on exam CIPNM: Absence of a decremental response, SNAP amplitudes < 80% of the lower limit of normal in two or more nerves, CMAP amplitudes < 80% of the lower limit of normal in two or more nerves without conduction block, sustained spontaneous activity and/or changes in motor unit recruitment, in at least two muscles, and MRC score < 48 or clinical weakness on exam
7 secondary outcomes
ICU length of stay
Time frame: upon completion of ICU stay, commonly 7-14 days.
ICU-free days
Time frame: upon completion of inpatient period, commonly up to 28 days.
time on mechanical ventilation
Time frame: upon completion of ventilation period, commonly 3-14 days.
hospital length of stay
Time frame: upon completion of inpatient period, commonly up to 28 days.
hospital-free days
Time frame: 28 days
in hospital mortality
Time frame: 28 days
Discharge location
Time frame: up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Moss, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Ultrasound, Nerve Conduction Study and Electromyography in people with Critical Illness, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aims 1.1-1.3: Number of medical ICU subjects diagnosed with CIPNM according to Moss/Quan established criteria of CIP or CIM. (time frame: Weekly up to Day 28 or hospital discharge whichever occurs first.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.