Cerebral Blood Flow During CPB During Cardiac Surgery and the Presence of Post op Delirium
Non Invasive Monitoring of Cerebral Blood Flow During and After Cardiopulmonary Bypass to Assess and Compare for the Presence of Delirium in Post Operative Patients (DELIRIUM)
調査の概要
状態
条件
詳細な説明
Cardiac surgery is associated with multiple perturbations that increase risk for adverse postoperative neurological outcomes including postoperative cognitive dysfunction. These same perturbations likely also increase the risk for postoperative delirium although there are little data that have evaluated this hypothesis.
As the subject is prepared for surgery 2 contact probes will be placed on the forehead to monitor the rSO2 and cerebral blood flow. This monitor can also measureblood flow velocity in blood vessels in the forehead.
This will only be done while the subject is on the cardiac bypass machine during the surgery and end shortly after entering the intensive care unit.Prior to surgery and then once a day on three of the first four postoperative days, patients will be assessed for the presence and severity of delirium with brief standard psychological exams. We will compare rSO2 and CBF changes between patients with and without delirium
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Maryland
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Baltimore、Maryland、アメリカ、21287
- Johns Hopkins Hospital
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients in the study will be 50 or older undergoing elective cardiovascular surgery using cardiopulmonary bypass.
- Patients who can speak, read and understand the English language.
- Patients who understand the nature of the study and are willing to sign the consent form
Exclusion Criteria:
- Emergency surgery or patients intubated before surgery and, thus, cannot give informed consent.
- Patients diagnosed with neurocognitive disorders (e.g. Alzheimer's, Dementia)
- MMSE score greater than 21 Patients taking antipsychotic drugs A history of drug abuse
- Patients with an implant in the brain underneath the CerOx probes
- Women who are pregnant.
- History of significant, prohibitive skin allergies or reactions-
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
コホートと介入
グループ/コホート |
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no intervention
Contact with enrolled subjects requires application of ceberal oximetry electrodes and the concommittent ultrasound of the temporal artery.
Deemed interventional by JHUIRB but no actual intervention done to subject.
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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 |
|---|---|---|
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To evaluate whether rSO2 and/or CBF during CPB is lower in patients who experience delirium within three days after cardiac surgery compared with patients without delirium
時間枠：3 days post op
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To evaluate whether rSO2 and/or CBF during CPB is lower in patients who experience delirium within three days after cardiac surgery compared with patients without delirium.
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3 days post op
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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recovery pattern of rSO2
時間枠：3 post op days
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To evaluate the recovery pattern of rSO2 and CBF for up to 6 hrs after CPB for ICU patients who experience delirium within three days after cardiac surgery compared with patients without delirium.
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3 post op days
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Can CBF autoregulation can be monitored using ultrasound compared with TCD
時間枠：3 days post op
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To assess whether CBF autoregulation can be monitored using ultrasound tagged light methodology compared with TCD
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3 days post op
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To evaluate the incidence of delirium in patients with impaired autoregulation
時間枠：3 days post op
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To evaluate the incidence of delirium in patients with impaired autoregulation
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3 days post op
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Kaushik Mandal, MD、Johns Hopkins University
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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。