Effects Of Invasive And Noninvasive Mechanical Ventilation On Sleep In The Intensive Care Unit (ICU)
Effects Of Invasive And Noninvasive Mechanical Ventilation On Sleep In The Icu
調査の概要
詳細な説明
Sleep in critically-ill patients is commonly severely fragmented, and sleep architecture is altered as compared to a healthy person. This abnormal sleep may cause some important adverse psychological and physiological consequences. Noise, light, patient-care activities, pain, or medications are some of the contributing factors to sleep disruption in the ICU. Recent evidence also suggests that invasive mechanical ventilation (IMV) itself may lead to sleep fragmentation in the ICU. Noninvasive ventilation (NIV) is a well-established, relatively new form of ventilation which improves sleep quality or gas exchange in some patients with chronic hypoventilatory disorders. Although sleep may be disrupted due to discomfort from the mask or air leaking during NIV use; intermittent use of NIV may result in better sleep quality between NIV sessions. The effects of NIV on sleep in the acute care setting have not yet been studied.
The purpose of the study is to describe the sleep architecture of a cohort of critically-ill patients using NIV, comparing findings to a reference group of patients using (IMV).
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02111
- Tufts-New England Medical Center Medical ICU and Coronary Care Unit
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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:
- Age > 18 yrs
- Receiving invasive or noninvasive mechanical ventilation
- Anticipated further ventilation of at least 24-hour duration for IMV and 8 hours/ 24 hours for NIV
Exclusion Criteria:
- Pre-morbid diseases that could interfere with interpretation of sleep monitoring including CNS disorders (strokes, encephalopathic states), dementia, and known sleep disorders
- On home BiPAP or CPAP
- Depressed sensorium as evidence by Glasgow Coma Score < 10, need for continuous sedation with Riker Score < 2 and inability to follow verbal commands for sustained 3 hours
- Presence of head trauma, psychiatric illness (including use of antidepressant medication), anoxic brain injury, drug overdose or uncontrolled seizure disorder
- Severe hemodynamic instability (BP< 90 mmHg despite vasopressor therapy) and sepsis
- Recalcitrant hypoxemia (inability to sustain SaO2 > 88%)
- Considered as unstable by ICU team (hemodynamic instability, acute uncontrolled GI bleeding, acute cardiac ischemia or arrhythmias)
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
- 観測モデル：ケースコントロール
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
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1
critically ill patients undergoing invasive mechanical ventilation in medical ICU and CCU
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2
critically ill patients undergoing noninvasive mechanical ventilation in medical ICU and CCU
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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 |
時間枠 |
|---|---|
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To define sleep characteristics in critically-ill patients receiving mechanical ventilation in medical ICU and coronary care unit (CCU)
時間枠：During 24-hour monitorization period (after recruitment into the study)
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During 24-hour monitorization period (after recruitment into the study)
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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To compare total sleep time and differences in sleep architecture including time spent in different sleep stages and arousals in critically-ill patients receiving mechanical ventilation in medical ICU and CCU
時間枠：During 24-hour monitorization
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During 24-hour monitorization
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To determine sleep patterns during NIV use, correlating sleep with periods of use and air leaking
時間枠：During 24-hour monitorization
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During 24-hour monitorization
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To monitor environmental factors including noise, light and patient care activities, and to associate these with sleep patterns
時間枠：During 24-hour monitorization
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During 24-hour monitorization
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To assess associations of severity of illness and sedation usage with sleep patterns
時間枠：During 24-hour monitorization period
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During 24-hour monitorization period
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Aylin Ozsancak, MD、research fellow
- 主任研究者：Nicholas S Hill, MD、Chair of Pulmonary, Critical Care and Sleep Medicine Division
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。