Trial Outcomes & Findings for Comparison of Different Ventilator and Vaporizer Technologies to Study Economic and Environmental Implications (NCT NCT04851314)

Results Overview

The purpose of this study is to test whether or not the use of a low volume ventilator in an anesthesia machine reduces anesthetic costs significantly as compared to other high volume machines. The study will compare the FLOW-i anesthesia machine to a GE anesthesia machine during routine elective general surgery in patients with ASA ratings of 1-2 under general anesthesia receiving standard care.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

110 participants

Primary outcome timeframe

Intraoperative (minimum of 2 hours of anesthesia)

Results posted on

2021-08-10

Participant Flow

Some enrolled subjects were excluded due to unforeseen circumstances in the clinical workflow e.g. a change in anesthetic preference or canceled surgery. Data from these cases could not provide meaningful results for analysis.

Participant milestones

Participant milestones
Measure	Maquet Flow-i C20 Subjects receiving the Maquet Flow-i C20 anesthetic delivery machine will undergo standardized anesthetic protocol to evaluate anesthetic consumption rates	GE Aisys CS2 Subjects receiving the GE Aisys CS2 anesthetic delivery machine will undergo standardized anesthetic protocol to evaluate anesthetic consumption rates
Overall Study STARTED	55	55
Overall Study COMPLETED	52	51
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Maquet Flow-i C20 Subjects receiving the Maquet Flow-i C20 anesthetic delivery machine will undergo standardized anesthetic protocol to evaluate anesthetic consumption rates	GE Aisys CS2 Subjects receiving the GE Aisys CS2 anesthetic delivery machine will undergo standardized anesthetic protocol to evaluate anesthetic consumption rates
Overall Study Unable to complete research set-up procedures	0	2
Overall Study Change in Anesthesia Plan (patient no longer meets inclusion criteria)	3	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Maquet Flow-i C20 n=52 Participants Subjects receiving the Maquet Flow-i C20 anesthetic delivery machine will undergo standardized anesthetic protocol to evaluate anesthetic consumption rates.	GE Aisys CS2 n=51 Participants Subjects receiving the GE Aisys CS2 anesthetic delivery machine will undergo standardized anesthetic protocol to evaluate anesthetic consumption rates.	Total n=103 Participants Total of all reporting groups
Age, Continuous	42 years STANDARD_DEVIATION 14 • n=52 Participants	44 years STANDARD_DEVIATION 13 • n=51 Participants	43 years STANDARD_DEVIATION 13 • n=103 Participants
Sex: Female, Male Female	35 Participants n=52 Participants	29 Participants n=51 Participants	64 Participants n=103 Participants
Sex: Female, Male Male	17 Participants n=52 Participants	22 Participants n=51 Participants	39 Participants n=103 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Intraoperative (minimum of 2 hours of anesthesia)

Population: Completed patient population for each ventilator type

The purpose of this study is to test whether or not the use of a low volume ventilator in an anesthesia machine reduces anesthetic costs significantly as compared to other high volume machines. The study will compare the FLOW-i anesthesia machine to a GE anesthesia machine during routine elective general surgery in patients with ASA ratings of 1-2 under general anesthesia receiving standard care.

Outcome measures

Outcome measures
Measure	Maquet Flow-i C20 n=52 Participants Maquet Flow-i C20 (ICU certified ventilator): Examine anesthetic consumption rates	GE Aisys CS2 n=51 Participants GE Aisys CS2 (Non-ICU certified ventilator): Examine anesthetic consumption rates
Primary Study Variable: Amount of Gas Vaporized Anesthetic Per Minute Anesthesia	95.48 grams/minute Standard Deviation 49.29	119.3 grams/minute Standard Deviation 62.22

SECONDARY outcome

Timeframe: Up to 24 hours

Population: same as primary outcome measure

Time it took for patient to be safely discharged from the post-anesthesia care unit (PACU). The Aldrete Score evaluates recovery after anesthesia and patient readiness to be discharged from PACU. The patient is assessed for consciousness, mobility, breathing, circulation, and color. The evaluation occurs immediately after surgery and then every (1) hour before the patient is deemed ready for discharge.

Outcome measures

Outcome measures
Measure	Maquet Flow-i C20 n=52 Participants Maquet Flow-i C20 (ICU certified ventilator): Examine anesthetic consumption rates	GE Aisys CS2 n=51 Participants GE Aisys CS2 (Non-ICU certified ventilator): Examine anesthetic consumption rates
Time to Reach Aldrete > 8	98.13 minutes Standard Deviation 51.83	89.18 minutes Standard Deviation 52.09

SECONDARY outcome

Timeframe: Intraoperative (minimum of 2 hours of anesthesia)

Population: same as primary outcome

Time it took to remove patient from mechanical ventilation

Outcome measures

Outcome measures
Measure	Maquet Flow-i C20 n=52 Participants Maquet Flow-i C20 (ICU certified ventilator): Examine anesthetic consumption rates	GE Aisys CS2 n=52 Participants GE Aisys CS2 (Non-ICU certified ventilator): Examine anesthetic consumption rates
Time to Extubation From Weaning	10.37 minutes Standard Deviation 6.321	10.78 minutes Standard Deviation 6.413

Adverse Events

Maquet Flow-i C20

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

GE Aisys CS2

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

Dr. Robert Ryan Field

UC Irvine Health

Phone: 7145065703

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place