The Diagnosis and Incidence of Critical Illness Polyneuromyopathy in Medical and Neurosurgical ICU Patients

NCT02634658 | Completed

• 1 other identifier: 15-1557
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Weekly through Day 28 or hospital discharge whichever occurs first

Secondary Outcomes (7)

• ICU length of stay

  upon completion of ICU stay, commonly 7-14 days.

• ICU-free days

  upon completion of inpatient period, commonly up to 28 days.

• time on mechanical ventilation

  upon completion of ventilation period, commonly 3-14 days.

• hospital length of stay

  upon completion of inpatient period, commonly up to 28 days.

• hospital-free days

  28 days

Study Arms (2)

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).

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).

Other: Nerve Conduction Study; Other: Electromyography

Interventions

Muscle Ultrasound OTHER

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.

Also known as: US, Ultrasound

Medical ICU Subjects

Nerve Conduction Study OTHER

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.

Also known as: NCS

Medical ICU Subjects; Neuro ICU Subjects

Electromyography OTHER

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).

Also known as: EMG

Medical ICU Subjects; Neuro ICU Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.
• ii. 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
• Non-traumatic subarachnoid hemorrhage or intracerebral (intraparenchymal) hemorrhage.

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Critical Illness

Interventions

High-Energy Shock Waves; Neurofeedback

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Marc Moss, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: December 18, 2015
• Study Start: June 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: September 1, 2015
• Last Updated: May 4, 2017

Record last verified: 2017-05

Locations

US (1)