Hyperfine による ECMO ABI 検出
小児の体外膜酸素化における急性脳損傷の検出のための低磁場ベッドサイド MRI
The primary objective is to characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support. The secondary objective is to describe the time course and rates of ABI using ultralow-field bedside MRI relative to both duration of ECMO support and clinical imaging obtained in routine care of pediatric ECMO patients.
調査の概要
詳細な説明
Extracorporeal membrane oxygenation (ECMO) is frequently used to treat refractory cardiovascular and/or respiratory failure. As the support modality has evolved, survival has significantly improved, yet there are high rates of acute brain injury (ABI) in this population due to disease, patient, and treatment factors. This results in significant morbidity and mortality. Specifically, thromboembolic, hypoxic-ischemic, and hemorrhagic complications occur during ECMO support, but the investigators are limited in the monitoring and diagnosis of ABI while on ECMO as currently available imaging modalities (i.e. ultrasound [US], computed tomography [CT]) have low sensitivity for early hypoxic, cerebrovascular, and ischemic brain injuries. The sensitivity of these modalities increases only when it is too late to effectively intervene. Standard magnetic resonance imaging (MRI) is the gold standard to diagnose stroke and ischemic brain injury but is incompatible with ECMO devices. Swoop (Hyperfine, Guilford, CT) is an FDA cleared ultralow-field portable MRI system that can be used at the bedside and has been studied in critically ill adults with various types of ABI. This novel bedside MRI has been safely operated in clinical environments with equipment that is typically not MRI compatible. A few adult and pediatric ECMO patients have undergone bedside brain MRIs showing feasibility. Yet, what remains unknown is the true prevalence and timing of hypoxic, cerebrovascular, and ischemic brain injuries in pediatric ECMO.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Maura Sien, MSML, CCRC
- 電話番号：78311 8163028311
- メール：mesien@cmh.edu
研究場所
-
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Missouri
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Kansas City、Missouri、アメリカ、64108
- 募集
- Children's Mercy
-
コンタクト：
- Maura Sien, RT(R), CCRC
- メール：mesien@cmh.edu
-
コンタクト：
- Jessica Wallisch, MD
- メール：jwallisch@cmh.edu
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
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Participants that will be or are admitted to the Pediatric Intensive Care Unit, Cardiac Intensive Care Unit, or the Neonatal Intensive Care Unit
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Ages 0-17 years
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Participants that are at high risk for undergoing ECMO or are currently undergoing venovenous or venoarterial ECMO
• High risk participants include, but are not limited to:
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Undergoing cardiac surgery
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Congenital heart disease
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Congenital diaphragmatic hernia
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Refractory hypoxemic and/or hypercarbic respiratory failure
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Vasoactive-refractory shock
Exclusion Criteria:
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Pregnancy
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Any patient who has a contraindication to having an MRI
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Patients with a passive or active implant will:
- First be reviewed on MRISafety.com to determine MR conditionality
- If device is listed as Conditional or Unsafe for a 1.5T or a 3T, device will then be reviewed by MRI Safety Officer or MRI Physician Section chief to determine true conditionality for the portable MRI
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Portable MRI Arm
All subjects enrolled will be assigned to Arm 1 |
Enrolled subjects will undergo a Hyperfine MRI exam, which is a portable, low-field MRI, at various timepoints during their clinical course on ECMO. Patients will undergo imaging within 36 hours of ECMO initiation/cannulation. Patients that remain on ECMO will have repeat imaging at 72-120 hours of ECMO therapy and again weekly for the duration of their ECMO course. Patients may also undergo a portable MRI within 24 hours of clinical head imaging, if applicable. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support.
時間枠：Duration of ECMO treatment period, an average of <2 weeks
|
Perform bedside MRI in pediatric ECMO patients treated in pediatric, cardiac, and neonatal intensive care units (ICUs) within 36 hours of cannulation. Determine rates of ABI (hypoxic, ischemic, cerebrovascular, and hemorrhagic injury along with assessment of cerebral edema and midline shift) in the pre- and peri-cannulation time periods. Correlate these imaging findings to rates of clinical neurological events (seizures, pupillary changes, focal neurological examination). |
Duration of ECMO treatment period, an average of <2 weeks
|
|
Describe the time course and rates of ABI using ultralow-field bedside MRI relative to both duration of ECMO support and clinical imaging obtained in routine care of pediatric ECMO patients.
時間枠：Duration of ECMO treatment period, an average of <2 weeks
|
Obtain bedside MRI in pediatric ECMO patients treated in pediatric, cardiac or neonatal ICUs at 72-120 hours post-cannulation and weekly until decannulation. Quantify and compare rates of ABI between bedside MRI and CT or US as read by blinded neuroradiologist. |
Duration of ECMO treatment period, an average of <2 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Assess the association of clinical neurologic events to presence and type of imaging findings.
時間枠：From ICU admission to final neuroimaging during active study participation
|
Rates of seizures, pupillary changes, focal neurologic deficits, and neuromonitoring data will be correlated to neuroimaging diagnoses of acute brain injury. |
From ICU admission to final neuroimaging during active study participation
|
協力者と研究者
捜査官
- 主任研究者：Jessica Wallisch, MD、Children's Mercy Kansas City
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY00003208
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
There is reasonable concern that sharing of IPD could allow patient re-identification given the single center study design involving a small and unique patient cohort. Given consideration for patient privacy, IPD will not be shared on open data platforms. De-identified IPD is available at reasonable request to the study PI with IRB approval and appropriate contracting.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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