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The aim of this study is to compare the sedation effects between remifentanil and dexmedetomidine in post-cardiac surgical patients who developed noninvasive ventilation (NIV) intolerance.
This study is a prospective,observational,cohort study. Data of post-cardiac surgical patients who receives noninvasive ventilation (NIV) in the investigators' cardiac surgical intensive care unit are prospectively collected into a database for further analyzation since January 2018. Tolerance of NIV is estimated by a four-point NIV intolerance score system: A score of 1 indicates a comfortable and relaxed patient tolerating NIV; a score of 2 indicates mild intolerance with some discomfort and occasional grabbing at the NIV mask; a score of 3 indicates moderate intolerance and discomfort with the NIV mask most of the time with frequent grabbing at the mask (sometimes pulling it off); and a score of 4 indicates severe NIV intolerance with agitation or/and an inability to leave the NIV mask in place. Participants who receives re-intubation will be recorded as 4 points. Application of remifentanil or dexmedetomidine will be initiated when a score of 3 or 4 was recorded, according to the intensivists' preference.Depending on the sedation regime applied, patients with NIV intolerance are divided into two groups: remifentanil group and dexmedetomidine group.The investigators will compare the two groups with the NIV intolerance score at 15min,1, 3, 6, 12, 24, 48, 60 and 72 hours after the initiation of the sedation regime. The investigators will also compare the two groups with clinical outcomes such as NIV failure, tracheotomy rate, mortality, ICU length of stay etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| remifentanil group | Eligible patients will receive a continuous infusion of remifentanil starting with 0.05 μg/kg/min. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 0.12 μg/kg/min. |
| |
| dexmedetomidine group | Eligible patients will receive a continuous infusion of dexmiditomidine starting with 0.5 μg/kg/h. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 1 μg/kg/h. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil | Drug | The noninvasive ventilation intolerated patients was sedated by remifentanil. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With NIV Failure | NIV failure was defined by reintubation or death in the course of this study | 72 hours after the initiation of sedation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With NIV Mitigation | Mitigation was defined by patients who were relieved from the initial intolerant status | 72 hours after the initiation of sedation |
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Inclusion Criteria:
Exclusion Criteria:
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All adult cardiac surgical patients who receive NIV and develop moderate to severe intolerance (NIV intolerance score of 3 or 4) between January 2018 and December 2019 in our CSICU will be enrolled in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Guo-wei Tu, PhD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan hospital, Fudan university | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Remifentanil Group | Eligible patients will receive a continuous infusion of remifentanil starting with 0.05 μg/kg/min. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 0.12 μg/kg/min. Remifentanil: The noninvasive ventilation intolerant patients was sedated by remifentanil. |
| FG001 | Dexmedetomidine Group | Eligible patients will receive a continuous infusion of dexmiditomidine starting with 0.5 μg/kg/h. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 1 μg/kg/h. Dexmedetomidine: The noninvasive ventilation intolerant patients was sedated by dexmeditomidine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Remifentanil Group | Eligible patients will receive a continuous infusion of remifentanil starting with 0.05 μg/kg/min. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 0.12 μg/kg/min. Remifentanil: The noninvasive ventilation intolerated patients was sedated by remifentanil. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With NIV Failure | NIV failure was defined by reintubation or death in the course of this study | Summary statistics are expressed as numbers and percentages and compared between groups by Chi-square test. | Posted | Count of Participants | Participants | 72 hours after the initiation of sedation |
|
72 hours after the initiation of sedation regime
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Remifentanil Group | Eligible patients will receive a continuous infusion of remifentanil starting with 0.05 μg/kg/min. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 0.12 μg/kg/min. Remifentanil: The noninvasive ventilation intolerant patients was sedated by remifentanil. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr Zhe Luo | Zhongshan Hospital, Fundan university | 64041990 | ec@zs-hospital.sh.cn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 15, 2017 | Oct 16, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Dexmedetomidine | Drug | The noninvasive ventilation intolerated patients was sedated by dexmeditomidine. |
|
| BG001 | Dexmedetomidine Group | Eligible patients will receive a continuous infusion of dexmiditomidine starting with 0.5 μg/kg/h. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 1 μg/kg/h. Dexmedetomidine: The noninvasive ventilation intolerated patients was sedated by dexmeditomidine. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| baseline NIV intolerance score | In this study, tolerance of NIV is estimated by a four-point NIV intolerance score system: A score of 1 indicates NIV tolerance; a score of 2 indicates mild intolerance with some discomfort and occasional grabbing at the NIV mask; a score of 3 indicates moderate intolerance and discomfort with the NIV mask most of the time with frequent grabbing at the mask (sometimes pulling it off); and a score of 4 indicates severe NIV intolerance with agitation or/and an inability to leave the NIV mask in place. And higher NIV intolerance score is considered worse outcome. | Count of Participants | Participants |
|
Eligible patients will receive a continuous infusion of dexmiditomidine starting with 0.5 μg/kg/h. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 1 μg/kg/h. Dexmedetomidine: The noninvasive ventilation intolerant patients was sedated by dexmeditomidine. |
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| Secondary | Number of Participants With NIV Mitigation | Mitigation was defined by patients who were relieved from the initial intolerant status | The generalized estimating equations approach was employed to analyze changes in the mitigation rate over time between the two groups. | Posted | Count of Participants | Participants | 72 hours after the initiation of sedation |
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| 6 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | Dexmedetomidine Group | Eligible patients will receive a continuous infusion of dexmiditomidine starting with 0.5 μg/kg/h. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 1 μg/kg/h. Dexmedetomidine: The noninvasive ventilation intolerant patients was sedated by dexmeditomidine. | 4 | 38 | 0 | 38 | 0 | 38 |
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| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |