Trial Outcomes & Findings for Probability Ramp Control of Propofol for EGD (NCT NCT01838304)

Results Overview

Following initial sedation, an infusion rate for propofol is determined by the CRNA (control) or software (experimental). If this rate is appropriate for the duration of the brief procedure, no adjustment to the rate will be required. A greater requirement for rate changes suggests that the anesthesia provider needs to be immediately available to perform these adjustments.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Intraprocedure (average of 9 minutes)

Results posted on

2018-01-23

Participant Flow

Participant milestones

Participant milestones
Measure	Monitoring Standard of care sedation by CRNA using proposal with manual recording of drug dosing Monitoring: Manual recording of drug doses determined by CRNA	Probability Ramp Control Propofol titrated to deep sedation using PRC software. Probability ramp control: Decision support software that calculates propofol doses appropriate for age and weight of the patient
Overall Study STARTED	20	20
Overall Study COMPLETED	19	20
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Probability Ramp Control of Propofol for EGD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Monitoring n=20 Participants Standard of care sedation by CRNA using proposal with manual recording of drug dosing Monitoring: Manual recording of drug doses determined by CRNA	Probability Ramp Control n=20 Participants Propofol titrated to deep sedation using PRC software. Probability ramp control: Decision support software that calculates propofol doses appropriate for age and weight of the patient	Total n=40 Participants Total of all reporting groups
Age, Continuous	48.5 years STANDARD_DEVIATION 14.2 • n=5 Participants	52.8 years STANDARD_DEVIATION 16.5 • n=7 Participants	50.625 years STANDARD_DEVIATION 15.345 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
ASA 3	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Weight	82.3 kg STANDARD_DEVIATION 27.4 • n=5 Participants	82.1 kg STANDARD_DEVIATION 23.9 • n=7 Participants	82.22 kg STANDARD_DEVIATION 25.4 • n=5 Participants

PRIMARY outcome

Timeframe: Intraprocedure (average of 9 minutes)

Following initial sedation, an infusion rate for propofol is determined by the CRNA (control) or software (experimental). If this rate is appropriate for the duration of the brief procedure, no adjustment to the rate will be required. A greater requirement for rate changes suggests that the anesthesia provider needs to be immediately available to perform these adjustments.

Outcome measures

Outcome measures
Measure	Monitoring n=19 Participants Standard of care sedation by CRNA using proposal with manual recording of drug dosing Monitoring: Manual recording of drug doses determined by CRNA	Probability Ramp Control n=20 Participants Propofol titrated to deep sedation using PRC software. Probability ramp control: Decision support software that calculates propofol doses appropriate for age and weight of the patient
Number of Participants Requiring Adjustment in Propofol Dosing	16 Participants	2 Participants

SECONDARY outcome

Timeframe: Duration of sedation (average of 25 minutes)

Minute ventilation as determined by respiratory inductance plethysmography from initiation of sedation until emergence.

Outcome measures

Outcome measures
Measure	Monitoring n=19 Participants Standard of care sedation by CRNA using proposal with manual recording of drug dosing Monitoring: Manual recording of drug doses determined by CRNA	Probability Ramp Control n=20 Participants Propofol titrated to deep sedation using PRC software. Probability ramp control: Decision support software that calculates propofol doses appropriate for age and weight of the patient
Decrease in Minute Ventilation From Baseline	25 percentage of baseline Interval 20.0 to 30.0	50 percentage of baseline Interval 35.0 to 65.0

SECONDARY outcome

Timeframe: Duration of sedation (mean 25 minutes)

Number of seconds spent below saturation of 80%, reported as the total per group

Outcome measures

Outcome measures
Measure	Monitoring n=29686 seconds Standard of care sedation by CRNA using proposal with manual recording of drug dosing Monitoring: Manual recording of drug doses determined by CRNA	Probability Ramp Control n=30552 seconds Propofol titrated to deep sedation using PRC software. Probability ramp control: Decision support software that calculates propofol doses appropriate for age and weight of the patient
Time Spent Below a Saturation of 80%	168 seconds	22 seconds

SECONDARY outcome

Timeframe: Procedure time (average of 9 minutes)

Time from endoscopic intubation until completion of the procedure. This is not really an outcome measure, but is used to assess balance between groups.

Outcome measures

Outcome measures
Measure	Monitoring n=20 Participants Standard of care sedation by CRNA using proposal with manual recording of drug dosing Monitoring: Manual recording of drug doses determined by CRNA	Probability Ramp Control n=20 Participants Propofol titrated to deep sedation using PRC software. Probability ramp control: Decision support software that calculates propofol doses appropriate for age and weight of the patient
Procedure Time	9.03 minutes Standard Deviation 3.75	8.9 minutes Standard Deviation 4.75

Adverse Events

Monitoring

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Probability Ramp Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Monitoring n=20 participants at risk Standard of care sedation by CRNA using proposal with manual recording of drug dosing Monitoring: Manual recording of drug doses determined by CRNA	Probability Ramp Control n=20 participants at risk Propofol titrated to deep sedation using PRC software. Probability ramp control: Decision support software that calculates propofol doses appropriate for age and weight of the patient
Respiratory, thoracic and mediastinal disorders Desaturation	5.0% 1/20 • Number of events 1 • Duration of sedation (mean 25 minutes)	0.00% 0/20 • Duration of sedation (mean 25 minutes)

Additional Information

Vice-Chair of Research

University of Pennsylvania

Phone: (215) 662-3766

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place