Cardiac Surgery
Conditions
Keywords
noninvasive ventilation, remifentanil, dexmedetomidine, cardiac surgery
Brief summary
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.
Detailed description
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.
Interventions
DRUGRemifentanil
The noninvasive ventilation intolerated patients was sedated by remifentanil.
DRUGDexmedetomidine
The noninvasive ventilation intolerated patients was sedated by dexmeditomidine.
Sponsors
Shanghai Zhongshan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* adult patients * after cardiac surgery * receiving noninvasive ventilation * moderate to severe NIV intolerance (NIV intolerance score of 3 or 4)
Exclusion criteria
* difficult expectoration * pregnancy or breastfeeding * intensive care delirium screening checklist score more than 4 * drug abuse history * known allergy to opiods * cardiogenic shock * malignant arrhythmias
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With NIV Failure | 72 hours after the initiation of sedation | NIV failure was defined by reintubation or death in the course of this study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With NIV Mitigation | 72 hours after the initiation of sedation | Mitigation was defined by patients who were relieved from the initial intolerant status |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 52 |
| 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. | 38 |
| Total | 90 |
Baseline characteristics
| Characteristic | Dexmedetomidine Group | Total | Remifentanil Group |
|---|---|---|---|
| Age, Continuous | 67 years | 65 years | 65 years |
| baseline NIV intolerance score NIV intolerance score of 1 | 0 Participants | 0 Participants | 0 Participants |
| baseline NIV intolerance score NIV intolerance score of 2 | 0 Participants | 0 Participants | 0 Participants |
| baseline NIV intolerance score NIV intolerance score of 3 | 25 Participants | 56 Participants | 31 Participants |
| baseline NIV intolerance score NIV intolerance score of 4 | 13 Participants | 34 Participants | 21 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 38 Participants | 90 Participants | 52 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 38 Participants | 90 Participants | 52 Participants |
| Sex: Female, Male Female | 10 Participants | 29 Participants | 19 Participants |
| Sex: Female, Male Male | 28 Participants | 61 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 52 | 4 / 38 |
| other Total, other adverse events | 0 / 52 | 0 / 38 |
| serious Total, serious adverse events | 0 / 52 | 0 / 38 |
Outcome results
Primary
Number of Participants With NIV Failure
NIV failure was defined by reintubation or death in the course of this study
Time frame: 72 hours after the initiation of sedation
Population: Summary statistics are expressed as numbers and percentages and compared between groups by Chi-square test.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Remifentanil Group | Number of Participants With NIV Failure | 10 Participants |
| Dexmedetomidine Group | Number of Participants With NIV Failure | 8 Participants |
Comparison: Summary statistics are expressed as numbers and percentages and compared between groups by Chi-square test.p-value: 0.831Chi-squared
Secondary
Number of Participants With NIV Mitigation
Mitigation was defined by patients who were relieved from the initial intolerant status
Time frame: 72 hours after the initiation of sedation
Population: The generalized estimating equations approach was employed to analyze changes in the mitigation rate over time between the two groups.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Remifentanil Group | Number of Participants With NIV Mitigation | 44 Participants |
| Dexmedetomidine Group | Number of Participants With NIV Mitigation | 31 Participants |
p-value: 0.8Generalized estimating equations