用右美托咪定减少天数，作为重症监护病房的一部分睡眠促销捆绑包 (DELDEX)
作为睡眠促进束的一部分，右美托咪定的随机，安慰剂对照临床试验，以改善重症监护的睡眠
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.
研究概览
研究类型
注册 (估计的)
阶段
- 第一阶段早期
联系人和位置
学习联系方式
- 姓名：Elizabeth Wilcox, MD PhD
- 电话号码：1-780-407-3028
- 邮箱：mwilcox@ualberta.ca
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
|
安慰剂比较：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Recruitment rate
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Protocol Adherence
大体时间：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
大体时间：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
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- Pro00147451
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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 共享时间框架
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 共享访问标准
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 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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