Trial Outcomes & Findings for Combining Objective and Subjective Sedation Assessment Tools (NCT NCT00734409)

Results Overview

The mean amount of propofol used on each patient while the patient was in the ICU and receiving mechanical ventilation.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

300 participants

Primary outcome timeframe

Intensive Care Unit (ICU) stay through discharge

Results posted on

2013-03-29

Participant Flow

Patients were in the Medical ICU or Neuro ICU at Duke University Hospital or the mixed ICU at Durham Regional. If patients met all inclusion criteria and no exclusion criteria, the attending was asked if patient's legally authorized representative (LAR) could be approached for consent. Enrollment started May of 2008 and closed April of 2011.

Patients were only excluded from the trial after consent and prior to randomization if they no longer met inclusion criteria, for instance the medical team decided to remove sedatives.

Participant milestones

Participant milestones
Measure	RASS Plus BIS Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.	RASS Only Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
Overall Study STARTED	155	145
Overall Study COMPLETED	155	145
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combining Objective and Subjective Sedation Assessment Tools

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RASS Plus BIS n=155 Participants Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.	RASS Only n=145 Participants Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution	Total n=300 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	102 Participants n=5 Participants	99 Participants n=7 Participants	201 Participants n=5 Participants
Age, Categorical >=65 years	53 Participants n=5 Participants	46 Participants n=7 Participants	99 Participants n=5 Participants
Age Continuous	53.95 years STANDARD_DEVIATION 18.15 • n=5 Participants	57.7 years STANDARD_DEVIATION 15.30 • n=7 Participants	55.78 years STANDARD_DEVIATION 16.91 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	71 Participants n=7 Participants	147 Participants n=5 Participants
Sex: Female, Male Male	79 Participants n=5 Participants	74 Participants n=7 Participants	153 Participants n=5 Participants
Region of Enrollment United States	155 participants n=5 Participants	145 participants n=7 Participants	300 participants n=5 Participants

PRIMARY outcome

Timeframe: Intensive Care Unit (ICU) stay through discharge

Population: All patients who met eligibility requirements, consented for the trial, and were randomized were included in the analysis.

The mean amount of propofol used on each patient while the patient was in the ICU and receiving mechanical ventilation.

Outcome measures

Outcome measures
Measure	RASS Plus BIS n=155 Participants Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.	RASS Only n=145 Participants Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
Mean Sedative Use	13.35 ml/hour Standard Deviation 11.79	15.54 ml/hour Standard Deviation 11.88

SECONDARY outcome

Timeframe: ICU stay through discharge

Population: All patients who met eligibility requirements, consented for the trial, and were randomized were included in the analysis.

The number of unplanned self-device removal events that took place during the study period.

Outcome measures

Outcome measures
Measure	RASS Plus BIS n=155 Participants Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.	RASS Only n=145 Participants Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
Unplanned Self-device Removal Events	0 Event	1 Event

SECONDARY outcome

Timeframe: ICU stay- through discharge

Population: All patients who met eligibility requirements, consented for the trial, and were randomized were included in the analysis.

The mean number of days that the patients were on mechanical ventilation.

Outcome measures

Outcome measures
Measure	RASS Plus BIS n=155 Participants Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.	RASS Only n=145 Participants Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
Mean Days on Mechanical Ventilation	7.43 Days Standard Deviation 8.32	6.85 Days Standard Deviation 12.57

Adverse Events

RASS Plus BIS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

RASS Only

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	RASS Plus BIS n=155 participants at risk Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.	RASS Only n=145 participants at risk Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
Respiratory, thoracic and mediastinal disorders Unplanned Self-Device Removal Event	0.00% 0/155	0.69% 1/145 • Number of events 1

Additional Information

DaiWai M Olson, PhD RN

Duke University Health System

Phone: (919) 668-3751

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place