集中治療室の睡眠プロモーションバンドルの一部として、デクスメデトミジンで妄想日を減らす日 (DELDEX)
集中治療の睡眠を改善するための睡眠プロモーションバンドルの一部として、デクスメデトミジンのランダム化されたプラセボ対照臨床試験
Patients frequently experience problems with sleep while admitted to the ICU. Good sleep is important in ensuring that your immune system responds properly to infection, for your heart to function optimally, and to support normal brain function such as memory.
To address sleep problems in the ICU, a bundle of interventions to support more normal sleep are provided. These bundles consist of medications such as sedatives and environmental changes such as less frequent times being assessed overnight and noise reduction strategies. Although medications can make patients appear to be sleeping, most medications do not provide patients with restful sleep. More research is needed on medications that better mimick restful sleep. One such medication is dexmedetomidine. When formally measured dexmedetomidine can make sleep appear more like a patient sleeping at home as compared to the hospital.
The purpose of this study is to test whether giving a patient in the intensive care unit dexmedetomidine helps have a more restful sleep and possibly be more alert and/or interactive the next day.
To see if dexmedetomidine improves sleep, the investigators will compare the quality of sleep of two different groups of participants: one group that receives dexmedetomidine at night for 2 nights in a row and another group that does not. How well one sleeps will be measured, in either group, will be assessed by a portable sleep machine that is attached by several stickers.
This study is called a pilot or feasibility study. A pilot study assesses how easy it is to recruit patients, whether the sleep machine is tolerated, and amount of time sleep is measured.
It is anticipated that about 50 people will take part in this study. This study should take approximately 2 years to complete, and the results should be known in about 1-2 years thereafter.
調査の概要
研究の種類
入学 (推定)
段階
- 初期フェーズ 1
連絡先と場所
研究連絡先
- 名前：Elizabeth Wilcox, MD PhD
- 電話番号：1-780-407-3028
- メール：mwilcox@ualberta.ca
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:
- Adult patient aged 18 years old or over admitted to the ICU
- Anticipated to stay in the ICU for another 48 hours after the first sleep recording
- Mechanically ventilated or on high flow oxygen (Optiflow)
- Hemodynamically stable
- Conscious, non-sedated patient with capacity to complete a self-reported sleep assessment*
Exclusion Criteria:
- Contraindication to dexmedetomidine (including but not limited to allergy and bradycardia [heart rate < 50 beats per minute])
- Currently receiving dexmedetomidine or other alpha-2 agonists (e.g., clonidine)
- Patients with structural neurological disease (e.g., stroke or tumor or traumatic brain injury) or degenerative neurologic disease (e.g., Parkinson's disease or dementia) and GCS < 14
- Patients with second- or third-degree heart block (unless pacemaker implanted)
- Patients with clinically significant hepatic or renal disease
- Patients with limitations in therapy or actively being palliated
- Patients with primary psychiatric disorder (e.g., new diagnosis of or uncontrolled schizophrenia, severe depression)
- Patients experiencing substance intoxication or withdrawal (e.g., severely agitated delirium)
- Patients participating in other studies involving the use of pharmacologically active substances
- Treating clinician believes study participation is not in the patient's best interest
- Pregnancy or breastfeeding
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Intervention
Dexmedetomidine will be prepared at a concentration of 4 mcg/ml by diluting 200 mcg/2 ml vials with 48 mL of 0.9% normal saline to a total volume of 50 ml. A maintenance infusion of 0.2-1.2 mcg/kg/hr will be initiated to sustain the sedative effect and promote sleep throughout the trial period. ICU nurses are experienced in titrating dexmedetomidine for both patients on high flow oxygen (optiflow) and intubated patients with delirium as part of routine care. |
Dexmedetomidine will be prepared at a concentration of 4 mcg/ml by diluting 200 mcg/2 ml vials with 48 mL of 0.9% normal saline to a total volume of 50 ml. A maintenance infusion of 0.2-1.2 mcg/kg/hr will be initiated to sustain the sedative effect and promote sleep throughout the trial period. ICU nurses are experienced in titrating dexmedetomidine for both patients on high flow oxygen (Optiflow) and intubated patients with delirium as part of routine care. The ICU bedside nurse will be responsible for using the lowest effective dose to achieve a Richmond Agitation Sedation Scale (RASS) of -2, up to a maximum of 1.2 mcg/kg/hr, while monitoring for adverse events such as bradycardia and hypotension. |
|
プラセボコンパレーター：Control
Patients randomized to the control group will receive a placebo daily for 2 consecutive nights. |
The control group will receive an infusion of 0.9% saline at 5-45 ml/hr titrated to the lowest effective dose to achieve a RASS of -2 for two nights following randomization. |
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 |
|---|---|---|
|
Recruitment rate
時間枠：2 years
|
The number of participants enrolled per month will be reported with 95% confidence intervals. A recruitment rate of at least one participant per month per participating site will be considered supportive of progression to a larger trial. |
2 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Protocol Adherence
時間枠：2 years
|
Adherence to treatment duration protocol: The investigators will consider the main trial to be feasible if intervention is delivered 90% of scheduled duration (proportion of total hours study drug received during intervention period (20:00 - 06:00). Further, tolerance of Prodigy Sleep Machine will be evaluated for a similar proportion of time successfully worn (recordings that are of sufficient quality to permit analyses between 20:00 - 06:00). The investigators will report proportion of adherence with 95% confidence intervals. |
2 years
|
|
Sleep Quality Assessment
時間枠：2 years
|
We will monitor overnight sleep using the NOXA1s Sleep System. A trained assessor will attach the device at 17:00, remove the device at 08:00 the following morning and reattach at 17:00 later the same day. The patients will undergo the sleep study for one night prior to randomization, if the quality of data is deemed acceptable then they will be randomized to one of the two experimental groups (dexmedetomidine or placebo) and undergo the sleep study for two additional nights for a maximum of three consecutive nights. The sleep assessment will be performed with the associated Noxturnal Sleep Study software. |
2 years
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
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
追加の関連 MeSH 用語
その他の研究ID番号
- Pro00147451
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
al investigator and Steering Committee approval, ethics approval or exemption where applicable, and a signed institutional data-sharing agreement prohibiting re-identification and unauthorized onward sharing. Data will be provided securely, consistent with participant consent, ethics approvals and institutional requirements.
IPD 共有時間枠
De-identified IPD and supporting information will be available beginning 12 months after publication of the primary DELDEX pilot trial results and for five years thereafter.
IPD 共有アクセス基準
Qualified researchers may request de-identified IPD underlying the published results, a data dictionary, the study protocol and SAP for verification, secondary analyses or IPD meta-analyses. Requests must be submitted to the principal investigator using the contact details in the trial record and include the research question, requested data, analysis plan and secure data-handling arrangements. Access requires approval by the principal investigator and Steering Committee, research ethics approval or exemption where applicable, and a signed institutional data-sharing agreement prohibiting re-identification and unauthorized onward sharing. Approved materials will be provided through secure institutional transfer or access, consistent with participant consent, ethics approvals and institutional requirements.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
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
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