Trial Outcomes & Findings for Optiflow THRIVE for Delivery of Oxygen to Patients During Total Intravenous Anesthesia While Undergoing Radiology Procedures (NCT NCT04171037)

Results Overview

This measure is defined as the total length (in minutes) of all desaturation episodes that a patient experienced during a 60-minute observation window starting from the initiation of the propofol infusion. A desaturation episode is defined as a drop in oxygen saturation (SpO2) to 92% or lower.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

108 participants

Primary outcome timeframe

60-minute observation window starting from the initiation of the propofol infusion and continuing for 60 minutes

Results posted on

2025-07-24

Participant Flow

The IR procedure daily schedule will be used for patient selection. Once eligibility of a study candidate has been identified, the study coordinator will be informed to start the patient interview and obtain written informed consent.

A total of 114 patients were accrued, and 108 patients were randomized. Of the total number randomized, six patients were screen failures prior to the procedure and 1 patient had no follow-up measurements, leaving 101 patients deemed evaluable for the primary endpoint. This provided 50 patients on Optiflow THRIVE and 51 patients on Standard of Care.

Participant milestones

Participant milestones
Measure	Optiflow™ THRIVE Treatment group will receive oxygen via Optiflow™ THRIVE	Control Group (Non-rebreather Facemask) Control group will receive 100% oxygen via a non-rebreather facemask
Overall Study STARTED	54	54
Overall Study COMPLETED	50	51
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Optiflow™ THRIVE Treatment group will receive oxygen via Optiflow™ THRIVE	Control Group (Non-rebreather Facemask) Control group will receive 100% oxygen via a non-rebreather facemask
Overall Study Lost to Follow-up	1	0
Overall Study Physician Decision	3	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Optiflow™ THRIVE n=50 Participants Treatment group will receive oxygen via Optiflow™ THRIVE	Control Group (Non-rebreather Facemask) n=51 Participants Control group will receive 100% oxygen via a non-rebreather facemask	Total n=101 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=50 Participants	0 Participants n=51 Participants	0 Participants n=101 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=50 Participants	32 Participants n=51 Participants	62 Participants n=101 Participants
Age, Categorical >=65 years	20 Participants n=50 Participants	19 Participants n=51 Participants	39 Participants n=101 Participants
Age, Continuous	60.18 years STANDARD_DEVIATION 11.96 • n=50 Participants	60.96 years STANDARD_DEVIATION 11.97 • n=51 Participants	60.57 years STANDARD_DEVIATION 11.91 • n=101 Participants
Sex: Female, Male Female	22 Participants n=50 Participants	23 Participants n=51 Participants	45 Participants n=101 Participants
Sex: Female, Male Male	28 Participants n=50 Participants	28 Participants n=51 Participants	56 Participants n=101 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	50 participants n=50 Participants	51 participants n=51 Participants	101 participants n=101 Participants

PRIMARY outcome

Timeframe: 60-minute observation window starting from the initiation of the propofol infusion and continuing for 60 minutes

This measure is defined as the total length (in minutes) of all desaturation episodes that a patient experienced during a 60-minute observation window starting from the initiation of the propofol infusion. A desaturation episode is defined as a drop in oxygen saturation (SpO2) to 92% or lower.

Outcome measures

Outcome measures
Measure	Optiflow™ THRIVE n=50 Participants Treatment group will receive oxygen via Optiflow™ THRIVE	Control Group (Non-rebreather Facemask) n=51 Participants Control group will receive 100% oxygen via a non-rebreather facemask
Total Length of Desaturation Episodes (ToLDE) Per Patient/Surgical Procedure	34 minutes Standard Deviation 1.16	97 minutes Standard Deviation 3.25

SECONDARY outcome

Timeframe: 60-minute observation window starting from the initiation of the propofol infusion and continuing for 60 minutes

The total number of episodes where the patient's oxygen saturation (SpO2) dropped to 92% or lower.

Outcome measures

Outcome measures
Measure	Optiflow™ THRIVE n=50 Participants Treatment group will receive oxygen via Optiflow™ THRIVE	Control Group (Non-rebreather Facemask) n=51 Participants Control group will receive 100% oxygen via a non-rebreather facemask
Number of Desaturation Episode Events Per Patient/Surgical Procedure	7 Participants	13 Participants

SECONDARY outcome

Timeframe: 60-minute observation window starting from the initiation of the propofol infusion.

The total number of episodes where the bispectral index (BIS) value was 61 or higher, indicating inadequate sedation levels.

Outcome measures

Outcome measures
Measure	Optiflow™ THRIVE n=50 Participants Treatment group will receive oxygen via Optiflow™ THRIVE	Control Group (Non-rebreather Facemask) n=51 Participants Control group will receive 100% oxygen via a non-rebreather facemask
Number of BIS Episodes	2 Number of Episodes Interval 0.0 to 15.0	4 Number of Episodes Interval 0.0 to 19.0

SECONDARY outcome

Timeframe: up to 60 minutes after PACU admission

The length of time spent in the post-anesthesia care unit (PACU) in minutes.

Outcome measures

Outcome measures
Measure	Optiflow™ THRIVE n=50 Participants Treatment group will receive oxygen via Optiflow™ THRIVE	Control Group (Non-rebreather Facemask) n=51 Participants Control group will receive 100% oxygen via a non-rebreather facemask
PACU Observation Time	20 minutes Interval 0.0 to 60.0	26 minutes Interval 0.0 to 60.0

Adverse Events

Optiflow™ THRIVE

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group (Non-rebreather Facemask)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gang Zheng, MD

The University of Texas MD Anderson Cancer Center

Phone: (713) 563-2731

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place