ICU CONNECT Trial: A MultIcenter Comparison Cohort Trial EvalUating the Correlation Between nOn-iNvasive EMG and iNvasive EMG in Healthy Volunteers and Critically Ill PaTients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- bedside quantitative neuromuscular monitoring
研究概览
简要总结
This study is testing whether a non-invasive nerve monitoring device (TetraGraph) can accurately detect early signs of ICU-acquired weakness by comparing readings from the device with standard nerve conduction/EMG tests done by a specialist to see if they match. They will focus on muscle response signals in the hand and leg over about 10 days in three groups: healthy volunteers, ICU patients who are not on ventilators, and ICU patients who are on ventilators.
详细描述
This is a prospective, parallel-cohort controlled pilot trial involving adults who are either 1) healthy volunteers, 2) non-intubated critically ill Endeavor Health ICU patients, or 3) intubated critically ill Endeavor Health ICU patients. Each cohort will have 8 total participants for a total of 24 patients from Endeavor Health. The testing done in this study (EMG/NCS and TetraGraph) is not part of standard of care procedures for critically ill patients. These tests are being performed for research purposes only.
Participants in cohorts 2 and 3 (non-intubated ICU patients and intubated ICU patients) will be enrolled in the trial from the time they (or their LAR) sign the consent form to 90 days post-hospital discharge to allow for data collection regarding outcomes after their ICU stay. Enrollment of ICU patients will be within the first 72 hours of their ICU stay as our preliminary data suggested the CMAP amplitudes started to drop after this time. Healthy volunteers will be enrolled in the trial from the time they sign their consent form to 10 days after their first visit. Each patient will serve as their own control with regards to changes, if any, in amplitude and/or duration.
Neurological EMG/NCS Testing Methods. The investigators will sequentially record the handheld quantitative neuromuscular monitor data and standard EMG/NCS data on the following study days: 1, 5, 10. The standard EMG and NCS sessions will be conducted by a neurologist and four muscles will be tested during the EMG portion (all on same side): the abductor digiti minimi (hand), biceps (upper arm), vastus medialis (upper leg), and tibialis anterior (lower leg). The four muscles will be tested to confirm if the weakness is neurogenic, myopathic, or a mixed process in origin. These specific muscles were chosen to ensure that at least one proximal and one distal muscle group is tested in each limb in order to help clarify the diagnosis and cause of the weakness, if any exists. The landmarks to apply the surface electrodes for standard NCS testing will be as follows. To test the tibialis anterior, the research staff will place the active electrode at the proximal one-third of the line between the tip of the fibular head and the tip of the lateral malleolus. This is roughly one-third of the way down the shin, slightly lateral (2-3 cm) to the shin bone. The reference electrode will be placed 3-4 cm distal to the recording electrode on the tibial boney prominence. The ground electrode will be placed between the active electrode and stimulation probe. The cathode of the bipolar stimulating probe will be placed just inferior to the fibular head about 9-10 cm proximal to the recording electrode. For testing the abductor digiti minimi, the research staff will place the active electrode directly on the muscle belly of the ADM. This is on the ulnar border of the palm, approximately halfway between the wrist crease and the base of the little finger. The reference electrode will be placed over the distal joint (the fifth MCP joint) or on the proximal phalanx of the fifth digit, while the ground electrode will be placed on the dorsum of the hand between the active and reference electrodes. The cathode of the bipolar stimulating probe will be placed 7-8 cm proximal to the active electrode along the medial aspect of the anterior wrist over the ulnar nerve.
The skin temperature of the limbs will first be measured with a temporal infrared temperature device to record the temperature prior to testing. The participant's limb will be warmed using hot packs to at least 32-34 degrees celsius per AANEM guidlines to ensure proper nerve conduction velocity. These measurements will be taken at supramaximal stimulation current for consistency of measurements. More specifically, investigators will be using a polar probe to apply a current in the milliamp (mA) range. Investigators will start at 15 mA, stimulating at least 1-3 times before increasing stimulation by 5-20 mA and stimulating again three times. Investigators will continue to increase the current until the response amplitude stops growing (supramaximal stimulation) or investigators reach the maximum current intensity of 80 mA. If needed, investigators will also increase the duration of the stimulus from 0.1 milliseconds (ms) up to a maximum of 1 ms, usually by increments of 0.1-0.2 ms. The EMG/NCS measurements will be done one time and by a trained neurologist. No desensitization is expected between series of EMG tests conducted on the patients enrolled.
Peripheral Nerve Monitor (TetraGraph) Testing Methods Then, all participants will have the handheld quantitative neuromuscular monitor applied to the skin over the nerve distribution of two muscles (all on same side of body), the abductor digiti minimi (ADM) and tibialis anterior, to obtain CMAP amplitudes and duration. These specific muscles were chosen to ensure that at least one muscle from each limb is tested, and to correlate with the muscles tested in the EMG/NCS testing. To test the ADM and the tibialis anterior using the TetraGraph device, the surface electrodes will be placed as follows. For testing of the ADM, the research staff will place the two stimulating pads along the ulnar nerve on the volar aspect of the distal forearm. The recording pad will be placed over the muscle belly of the ADM, e.g., the outside edge of the palm near the fifth finger. The fourth (reference) electrode will be placed on the 5th finger. The response should be that the fifth finger should spread away from the rest of the fingers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cohort 1: Healthy volunteers
- •Inclusion criteria:
- •Subjects must be > 18 years old and < 90 years old.
- •Subjects must consent to participate. Cohort 2: Non-intubated critically ill patients
- •Inclusion criteria:
- •Subjects may be male or female.
- •Subjects must be > 18 years old and < 90 years old.
- •Subjects must have a POA or next of kin who is able to consent (for those in the ICU and who are unable to consent themselves).
- •Cohort 3: Intubated critically ill patients
- •Inclusion criteria:
- •Subjects may be male or female.
- •Subjects must be > 18 years old and < 90 years old.
- •Subjects must have a POA or next of kin who is able to consent (for those in the ICU and who are unable to consent themselves).
- •For the Subjects in the ICU that are intubated, they must be planned to be intubated for at least 24 hours.
- •Subjects must be intubated for no longer than ≥ 72 hours before enrollment.
排除标准
- •Cohort 1: Healthy volunteers
- •Exclusion criteria:
- •Subjects with previous paralysis or neuromuscular disease.
- •Subjects with spinal cord or brain injuries that impact motor function.
- •Subjects with an allergy to clinical adhesive or hydrogel. Cohort 2: Non-intubated critically ill patients
- •Exclusion criteria:
- •Subjects with previous paralysis or neuromuscular diseases.
- •Subjects with previous peripheral nerve injuries to the tested limbs.
- •Subjects with spinal cord or brain injuries (including stroke) that impact motor function.
- •Subjects without a POA or next of kin for those patients that are unable to consent themselves.
- •Subjects with an allergy to clinical adhesive or hydrogel. Cohort 3: Intubated critically ill patients
- •Exclusion criteria:
- •Subjects with previous paralysis or neuromuscular disease
- •Subjects with previous peripheral nerve injuries to the tested limbs.
- •Subjects with spinal cord or brain injuries that impact motor function.
- •Subjects without a POA or next of kin for those patients that are in the intubated arm.
- •Subjects with intubations expected to last less than 24 hours.
- •Subjects who have already been intubated for > 72 hours.
- •Subjects with an allergy to clinical adhesive or hydrogel.
研究组 & 干预措施
Healthy
Healthy volunteers will be recruited primarily through flyers placed in Endeavor Health hospitals and surrounding communities. They will undergo NCS, EMG, and Tetragraph testing on days 1,5,10
干预措施: TetraGraph (Device)
Healthy
Healthy volunteers will be recruited primarily through flyers placed in Endeavor Health hospitals and surrounding communities. They will undergo NCS, EMG, and Tetragraph testing on days 1,5,10
干预措施: Electromyography (Device)
Healthy
Healthy volunteers will be recruited primarily through flyers placed in Endeavor Health hospitals and surrounding communities. They will undergo NCS, EMG, and Tetragraph testing on days 1,5,10
干预措施: Nerve conduction studies (Device)
Critically Ill patients
Critically ill, non-intubated patients in an Endeavor Health ICU. They will undergo NCS, EMG, and Tetragraph testing on days 1,5,10
干预措施: TetraGraph (Device)
Critically Ill patients
Critically ill, non-intubated patients in an Endeavor Health ICU. They will undergo NCS, EMG, and Tetragraph testing on days 1,5,10
干预措施: Electromyography (Device)
Critically Ill patients
Critically ill, non-intubated patients in an Endeavor Health ICU. They will undergo NCS, EMG, and Tetragraph testing on days 1,5,10
干预措施: Nerve conduction studies (Device)
Intubated ICU patients
ICU patients that are intubated within the first 72 hours of their ICU stay as our preliminary data suggested the CMAP amplitudes started to drop after this time. they will undergo NCS, EMG, and Tetragraph testing on days 1,5,10
干预措施: TetraGraph (Device)
Intubated ICU patients
ICU patients that are intubated within the first 72 hours of their ICU stay as our preliminary data suggested the CMAP amplitudes started to drop after this time. they will undergo NCS, EMG, and Tetragraph testing on days 1,5,10
干预措施: Electromyography (Device)
Intubated ICU patients
ICU patients that are intubated within the first 72 hours of their ICU stay as our preliminary data suggested the CMAP amplitudes started to drop after this time. they will undergo NCS, EMG, and Tetragraph testing on days 1,5,10
干预措施: Nerve conduction studies (Device)
结局指标
主要结局
bedside quantitative neuromuscular monitoring
时间窗: day 1,5, and 10 of enrollment
The primary objective is to assess agreement between bedside quantitative neuromuscular monitoring and standard NCS/EMG for CMAP amplitude and duration at the abductor digiti minimi and tibialis anterior on study days 1,5, and 10 in three cohorts (healthy volunteers, non-intubated ICU patients, and mechanically ventilated ICU patients).
次要结局
- Longitudinal trend analysis of CMAP amplitudes(day 1,5,10 of enrollment)
- Hospital length of stay(From ICU admission through discharge or death, up to 90 days, whichever comes first.)
- Intubation length(From intubation through extubation in ICU or death, up to 90 days, whichever comes first.)
- Reintubation(From ICU admission through discharge or death, up to 90 days, whichever comes first.)
- Electrolyte levels(From hospital admission through discharge or death, up to 90 days, whichever comes first.)
- Daily activity Success(From extubation through discharge or death, up to 90 days, whichever comes first.)
- Muscle strenght(Days 1,5,10 of study date and 1 day before patient discharge)
- ICU illness severity(Day 1 and hospital discharge, up to 90 days or death, whichever comes first.)
- location of disposition(On the day of hospital discharge, up to 90 days post-admission.)
- ICUAW diagnosis(at or before 90 days post-hospital discharge)
- Pain scale(day 1,5,10 of study day)
- Hospital length of stay(From hospital admission through discharge or death, up to 90 days, whichever comes first.)
研究者
Cliodhna Ashe
Clincial Professor
Endeavor Health