Clinical trial NCT03395886: Remifentanil Versus Dexmedetomidine for Post-Cardiac Surgery Patients With Noninvasive Ventilation Intolerance
Official title: Remifentanil Versus Dexmedetomidine for Post-Cardiac Surgery Patients With Noninvasive Ventilation Intolerance: A Prospective, Observational,Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery
Keywords: noninvasive ventilation
remifentanil
dexmedetomidine
cardiac surgery
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With NIV Failure
timeFrame: 72 hours after the initiation of sedation
Secondary outcomes:
measure: Number of Participants With NIV Mitigation
timeFrame: 72 hours after the initiation of sedation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital, Fudan university
state: Shanghai
Study officials:
affiliation: Fudan University
name: Guo-wei Tu, PhD
role: PRINCIPAL_INVESTIGATOR
References: