Brain Blood Flow and Cerebral Autoregulation Monitoring in Critically Ill Children
2026年8月24日 更新者：University of Wisconsin, Madison
Transcranial Doppler Assessment of Cerebral Autoregulation and Blood Flow Velocity Patterns in Critically Ill Children: A Prospective Observational Study
This study uses a non-invasive (external) ultrasound test called Transcranial Doppler (TCD) to measure how blood flows through the major arteries of the brain of children receiving care in the Pediatric Intensive Care Unit (PICU).
TCD is already used for clinical reasons in many children, but it is not part of routine monitoring for every critically ill child.
By using TCD, the investigators hope to better understand how brain blood flow changes during illness.
They will also track children's functional status from before their illness to the time of PICU discharge to explore how brain blood flow patterns relate to neurological outcomes.125
participants will be enrolled and will be on study while in the PICU, estimated to be 3-14 days.
調査の概要
詳細な説明
Current clinical management of hemodynamics in critically ill children relies primarily on systemic parameters (e.g., blood pressure, heart rate) rather than direct assessment of cerebrovascular regulation. This approach may overlook individual variations in cerebral autoregulation (CA) capacity, potentially leading to suboptimal cerebral perfusion.
By prospectively evaluating TCD-derived CA indices in intubated pediatric patients with arterial blood pressure monitoring, this study aims to:
- Establish normative Cerebral blood flow velocity (CBFV) ranges for critically ill children
- Describe CBFV patterns across critically ill pediatric populations with varying neurologic risk profiles
- Characterize the prevalence of CA dysfunction in a heterogeneous PICU population
- Explore associations between CA/CBFV and functional outcomes
These data could:
- Provide age-stratified CBFV reference values for the PICU setting
- Identify patients at highest risk of neurological morbidity using population-specific thresholds
- Inform future trials of autoregulation-guided hemodynamic management
研究の種類
観察的
入学 (推定)
125
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Meg Baker
- 電話番号：meg.baker@wisc.edu
- メール：meg.baker@wisc.edu
研究場所
-
-
Wisconsin
-
Madison、Wisconsin、アメリカ、53792
- 募集
- American Family Children's Hospital PICU
-
副調査官：
- Talal Al Hendawi, MD
-
主任研究者：
- Neil Munjal, MD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
Mechanically ventilated pediatric patients (1 day-17.5 years) admitted to the PICU who meet eligibility criteria
説明
Inclusion Criteria:
- Has at least one Parent or Legal Guardian who is willing and able to provide informed consent in English
- Mechanically ventilated (Endotracheal tube)
- Indwelling arterial catheter
- Current patient in the American Family Children's Hospital PICU.
- 1 day to 17.5 years of age
Exclusion Criteria:
- Subjects with a known or obvious anatomic barrier preventing safe application of the transcranial Doppler probe (e.g., cranial dressings, cranial fixation hardware, ventricular access devices positioned over insonation sites, or bilateral craniectomies)
- Patient with known chronic hypertension
- Admission FSS score > 16
- Tracheostomized patient
- The designated sub-investigator (Dr. Talal Al Hendawi) and PI (Dr. Neil Munjal) are unavailable to perform the Transcranial Doppler scan at the time of eligibility. All study scans are performed by either Dr. Al Hendawi or Dr.Munjal to ensure standardization and data integrity. Therefore, if they are unavailable (e.g., due to clinical service, leave, or other scheduling constraints), the patient will not be enrolled in the study.
- Not suitable for study participation due to other reasons at the discretion of the investigators
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
PICU Patients
Mechanically ventilated pediatric patients (1 day-17.5 years) admitted to the PICU.
|
TCD measurements synchronized to arterial blood pressure and ventilatory data, performed once daily for up to 5 days during PICU admission plus one additional pre-extubation scan if applicable, approximately 30 minutes each.
Bilateral middle cerebral artery (MCA) insonation performed at each session.
他の名前：
|
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 |
|---|---|---|
|
Change in Functional Status Scale (FSS) from baseline to PICU discharge
時間枠：Baseline FSS reflects pre-morbid functional status as reported by parents/guardians at enrollment; follow-up FSS assessed at PICU discharge (estimated 3-14 days)
|
To assess the relationship between cerebral autoregulation and neurological outcomes in critically ill pediatric patients, FSS will be measured.
FSS has 6 domains: mental status, sensory, communication, motor function, feeding, and respiratory.
FSS is scored from 6 to 30, higher scores are indicative of more severe dysfunction.
|
Baseline FSS reflects pre-morbid functional status as reported by parents/guardians at enrollment; follow-up FSS assessed at PICU discharge (estimated 3-14 days)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Flow Index (Mx)
時間枠：data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
|
Mean Flow Index (Mx) will serve as the primary exposure variable in multivariable regression analyses relating cerebral autoregulation status to functional outcome, and will additionally be characterized across PICU subpopulations.
|
data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
|
|
Percent successful exams (complete bilateral MCA data)
時間枠：data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
|
Feasibility metric reflecting the proportion of TCD sessions yielding complete bilateral MCA data, used to assess protocol feasibility and sonographic success rates in the PICU setting.
|
data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
|
|
Time per exam (min)
時間枠：data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
|
Feasibility metric reflecting total time required per TCD session, used to assess protocol efficiency and burden on clinical care.
|
data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
|
|
Mean CBFV
時間枠：data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
|
To describe cerebral blood flow velocity patterns in critically ill pediatric patients, mean CBFV will be measured.
|
data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
|
|
Age-stratified CBFV values across pre-specified clinical subgroups (TBI, cardiac arrest, ECMO)
時間枠：data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
|
data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
|
|
|
Age-stratified Mx values across pre-specified clinical subgroups (TBI, cardiac arrest, ECMO)
時間枠：data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
|
data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Neil Munjal, MD、UW School of Medicine and Public Health
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年8月3日
一次修了 (推定)
2028年5月1日
研究の完了 (推定)
2028年5月1日
試験登録日
最初に提出
2026年5月21日
QC基準を満たした最初の提出物
2026年5月21日
最初の投稿 (実際)
2026年5月29日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月27日
QC基準を満たした最後の更新が送信されました
2026年8月24日
最終確認日
2026年8月1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
- 2026-0238
- SMPH/Pediatrics/Critical Care (その他の識別子：UW Madison)
- Protocol Version 3/3/26 (その他の識別子：UW Madison)
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?
いいえ
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
いいえ
米国FDA規制機器製品の研究
はい
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