Descriptive Analysis of Near Infrared Spectroscopy in Critically Ill and Injured Pediatric and Neonatal Patients (NIRSCI)
調査の概要
詳細な説明
At Arkansas Children's Hospital (ACH) Pediatric Emergency Department (PED), NIRS cerebral tissue oxygenation rSO2 monitoring has become an adjunct noninvasive monitoring assessment tool along with Pulse Oximetry and End-Tidal CO2 in the critically ill and injured neonatal and pediatric patients' resuscitation endeavors or management. This has become a standard monitoring tool for patients who require medical (possible strokes, diabetic ketoacidosis, increased intracranial pressure, altered mental status, sepsis, drowning, shock, rapid sequence intubations, seizures, altered mental status, strokes, possible shunt malfunctions) or trauma (non-accidental trauma, Level One or Two Trauma with altered mental status, traumatic brain injury, altered mental status with trauma history, vascular compromise) resuscitation efforts.
Data will be collected as a retrospective and prospective chart review from the electronic medical record of patients that were treated in the pediatric emergency department of Arkansas Children's Hospital from 10-1-13 who require medical (possible strokes, diabetic ketoacidosis, increased intracranial pressure, altered mental status, sepsis, drowning, shock, rapid sequence intubations, seizures, altered mental status, strokes, possible shunt malfunctions) or trauma (non-accidental trauma, Level One or Two Trauma with altered mental status, traumatic brain injury, altered mental status with trauma history, vascular compromise) resuscitation efforts. This study will be based on the patient information recorded in these records, such as age, medications delivered, vital signs, interventions and outcomes and compared to their PED NIRS cerebral tissue oxygenation rSO2 data. All study subject materials will be assigned a unique identifying code or number. The cerebral NIRS rSO2 data will be collected/graphed and de-identified.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Arkansas
-
Little Rock、Arkansas、アメリカ、72202
- Arkansas Children's Hospital
-
-
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:
- Trauma: non-accidental trauma, Level One or Two Trauma with altered mental status, traumatic brain injury, altered mental status with trauma history, vascular compromise
- Or medical: possible strokes, diabetic ketoacidosis, increased intracranial pressure, altered mental status, sepsis, drowning, shock, rapid sequence intubations, seizures, altered mental status, strokes, possible shunt malfunctions
Exclusion Criteria:
- none
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:Specific Aim
Correlating the NIRS/Cerebral Oximetry readings to the various critical ill and injured pediatric patients, trends, interventions, and outcomes
|
Correlating the NIRS/Cerebral Oximetry readings to the various critical ill and injured pediatric patients, trends, interventions, and outcomes
|
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 |
|---|---|---|
|
Observing Cerebral oximetry readings when patients present to the pediatric emergency department
時間枠:4 years
|
All study data will be obtained from the physical or electronic medical records obtained at Arkansas Children's Hospital.
Patient's NIRS and vital signs data will be in an excel format with de-identified patient information which will be age, interventions, and etiology as denoted as Medical vs. Trauma (see study population for inclusion criteria).
This is a data review with de-identified patient chart analysis for age, weight, past medical histories, co-morbidities, medical or surgical interventions, medications, seizures, duration of events, cardiac arrest, respiratory failure, intubations, and outcomes.
All relevant information will be entered into a Redcap database.
All study subject materials will be assigned a unique identifying code or number.
|
4 years
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。