Trial Outcomes & Findings for Pain, Agitation and Delirium (PAD) Protocol in the Duke CICU (NCT NCT02903407)
NCT ID: NCT02903407
Last Updated: 2020-07-13
Results Overview
Number of days of admission to the CICU during the index hospitalization
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
7 participants
Primary outcome timeframe
One month or hospital discharge, whichever time point comes first
Results posted on
2020-07-13
Participant Flow
Patients were recruited from the Duke CICU between September 1, 2017 and June 30, 2019. Patients were identified by the rounding team for potential inclusion in the sedation trial and then screened by study team members to determine whether they met inclusion criteria. Consent was obtained from eligible patient's primary decision maker.
No enrolled participants were excluded from the study prior to group assignment.
Participant milestones
| Measure |
Midazolam
IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
Propofol or Dexmedetomidine
Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pain, Agitation and Delirium (PAD) Protocol in the Duke CICU
Baseline characteristics by cohort
| Measure |
Midazolam
n=4 Participants
IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
Propofol or Dexmedetomidine
n=3 Participants
Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.5 years
n=99 Participants
|
57.0 years
n=107 Participants
|
70.0 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
3 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
BMI
|
36.1 kg/m^2
n=99 Participants
|
34.4 kg/m^2
n=107 Participants
|
34.4 kg/m^2
n=206 Participants
|
|
Ejection Fraction
|
30.0 Percentage of blood
n=99 Participants
|
55.0 Percentage of blood
n=107 Participants
|
40.0 Percentage of blood
n=206 Participants
|
PRIMARY outcome
Timeframe: One month or hospital discharge, whichever time point comes firstNumber of days of admission to the CICU during the index hospitalization
Outcome measures
| Measure |
Midazolam
n=4 Participants
IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
Propofol or Dexmedetomidine
n=3 Participants
Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
|---|---|---|
|
Intensive Care Unit Length of Stay
|
4.1 Days
Interval 3.6 to 6.7
|
10.0 Days
Interval 8.2 to 10.3
|
SECONDARY outcome
Timeframe: One month or hospital discharge, whichever time point comes firstAll-cause mortality during the hospitalization
Outcome measures
| Measure |
Midazolam
n=4 Participants
IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
Propofol or Dexmedetomidine
n=3 Participants
Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
|---|---|---|
|
In Hospital Mortality
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: One month or hospital discharge, whichever time point comes firstIndex hospitalization length of stay in days
Outcome measures
| Measure |
Midazolam
n=4 Participants
IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
Propofol or Dexmedetomidine
n=3 Participants
Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
|---|---|---|
|
Hospital Length of Stay
|
19.5 Days
Interval 15.0 to 23.5
|
30.0 Days
Interval 21.5 to 35.0
|
SECONDARY outcome
Timeframe: One month or hospital discharge, whichever time point comes firstPatients will be monitored for increased pressor requirement during the CICU stay
Outcome measures
| Measure |
Midazolam
n=4 Participants
IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
Propofol or Dexmedetomidine
n=3 Participants
Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
|---|---|---|
|
Number of Participants With Increased Vasopressor Requirement
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: One month or hospital discharge, whichever time point comes firstPatients will be monitored for bradycardia which may be associated with sedation drug. Average heart rate before, during and after use of drug will be recorded for each patient.
Outcome measures
| Measure |
Midazolam
n=4 Participants
IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
Propofol or Dexmedetomidine
n=3 Participants
Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
|---|---|---|
|
Number of Participants With Bradycardia
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: One month or hospital discharge, whichever time point comes firstDays requiring mechanical ventilation during the initial episode of intubation during the hospitalization
Outcome measures
| Measure |
Midazolam
n=4 Participants
IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
Propofol or Dexmedetomidine
n=3 Participants
Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
|---|---|---|
|
Number of Ventilator Days
|
2.5 Days
Interval 2.1 to 4.2
|
6.8 Days
Interval 3.9 to 8.4
|
SECONDARY outcome
Timeframe: One month or hospital discharge, whichever time point comes firstThe time (in days) from when the clinical care team documents a decision to pursue extubation until the time the patient was extubated
Outcome measures
| Measure |
Midazolam
n=4 Participants
IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
Propofol or Dexmedetomidine
n=3 Participants
Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
|---|---|---|
|
Number of Days From Decision to Extubate to True Extubation
|
0 Days
Interval 0.0 to 0.25
|
0 Days
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: One month or hospital discharge, whichever time point comes firstPopulation: CAM-ICU was only documented in 3/7 of the patients enrolled, all of whom were in the midazolam arm of the study. Only these patients were included in this analysis.
The number of days alive and free from delirium or coma during admission will be evaluated among patients with CAM-ICU documented
Outcome measures
| Measure |
Midazolam
n=3 Participants
IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
Propofol or Dexmedetomidine
Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
|---|---|---|
|
Number of Days Alive During Admission and Free From Delirium or Coma
|
14.0 Days
Interval 13.5 to 20.0
|
—
|
SECONDARY outcome
Timeframe: One month or hospital discharge, whichever time point comes firstWill use RASS (Richmond Agitation and Sedation Scale) to assess level of sedation as per standard of care by nurses in the CICU. Data that is recorded will be evaluated following discharge. The RASS ranges from -5 (unrousable) to +4 (combative) and 0 (zero) = alert and calm and goal sedation is considered a RASS level of 0 to -2.
Outcome measures
| Measure |
Midazolam
n=4 Participants
IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
Propofol or Dexmedetomidine
n=3 Participants
Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
|---|---|---|
|
Percentage of Time at Goal Sedation
|
63.3 percentage of time
Interval 43.8 to 70.8
|
63.2 percentage of time
Interval 56.6 to 64.4
|
SECONDARY outcome
Timeframe: One month or hospital discharge, whichever time point comes firstThe duration, in days, from withdrawal of sedation for mechanical ventilation until the time of discharge from the ICU
Outcome measures
| Measure |
Midazolam
n=4 Participants
IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
Propofol or Dexmedetomidine
n=3 Participants
Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
|---|---|---|
|
Time From Withdrawal of Sedation to ICU Discharge
|
1.6 Days
Interval 0.77 to 2.8
|
5.6 Days
Interval 2.8 to 5.8
|
SECONDARY outcome
Timeframe: One month or hospital discharge, whichever time point comes firstPopulation: Patients with CAM-ICU score documented in the CICU (3/7 participants, all in the midazolam arm of the study)
Will use the Confusion Assessment Method for the ICU (CAM-ICU) to assess presence of delirium as per standard of care by nurses in the CICU. Patients with CAM-ICU data recorded will be included.
Outcome measures
| Measure |
Midazolam
n=3 Participants
IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
Propofol or Dexmedetomidine
Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
|---|---|---|
|
Number of Participants With Delirium
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: One month or hospital discharge, whichever time point comes firstWill use the CPOT (Critical-Care Pain Observation Tool) score to assess pain level as per standard of care by nurses in the CICU. The CPOT has a range of 0 to 8. A CPOT score of ≤ 2 = minimal to no pain present and \>2 = unacceptable level of pain. Data that is recorded will be evaluated following discharge.
Outcome measures
| Measure |
Midazolam
n=4 Participants
IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
Propofol or Dexmedetomidine
n=3 Participants
Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
|---|---|---|
|
Pain Management
|
0.0 score on a scale
Interval 0.0 to 0.5
|
0.0 score on a scale
Interval 0.0 to 0.3
|
SECONDARY outcome
Timeframe: One month or hospital discharge, whichever time point comes firstFollowing ICU discharge, patient charts will be reviewed to evaluate whether they required reintubation. If so, will determine whether necessity of reintubation was related to delirium.
Outcome measures
| Measure |
Midazolam
n=4 Participants
IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Midazolam: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
|
Propofol or Dexmedetomidine
n=3 Participants
Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Propofol: IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
Dexmedetomidine: IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
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|---|---|---|
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Number of Participants Requiring Reintubation
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0 Participants
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1 Participants
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Adverse Events
Midazolam
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Propofol or Dexmedetomidine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place