Trial Outcomes & Findings for Evaluation and Control of WAG in PACU Within Patient and Caregiver Breathing Zone (NCT NCT02428413)

Results Overview

The measurement of Waste Anesthetic Gas in parts per million resolution emanating from the patient to the caregiver's breathing zone.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

125 participants

Primary outcome timeframe

1 hour post-operative recovery period

Results posted on

2016-11-25

Participant Flow

Patient screening took place in the day surgery unit at Memorial Hermann Hospital in the Texas Medical Center of Houston Texas between July 2015 and November 2015.

Participant milestones

Participant milestones
Measure	Standard Oxygen Mask Standard face mask to provide supplemental oxygen Standard oxygen mask: Provide supplemental oxygen	ISO-Gard Mask Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen. ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen
Overall Study STARTED	64	61
Overall Study COMPLETED	56	52
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard Oxygen Mask Standard face mask to provide supplemental oxygen Standard oxygen mask: Provide supplemental oxygen	ISO-Gard Mask Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen. ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen
Overall Study Device to measure WAG malfunctioned	3	5
Overall Study Protocol Violation	1	2
Overall Study Case Cancelled	2	0
Overall Study Missed Cases	1	2
Overall Study Nurse Refusal	1	0

Baseline Characteristics

Evaluation and Control of WAG in PACU Within Patient and Caregiver Breathing Zone

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Oxygen Mask n=56 Participants Standard face mask to provide supplemental oxygen Standard oxygen mask: Provide supplemental oxygen	ISO-Gard Mask n=52 Participants Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen. ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen	Total n=108 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	49 Participants n=5 Participants	42 Participants n=7 Participants	91 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	28 Participants n=7 Participants	69 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	24 Participants n=7 Participants	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour post-operative recovery period

Population: A study size of 100 randomized subjects will be used. Aforementioned sample size was determined to be able to detect an effect size of 0.57 that would provide 80% power and 5% type I error (95% confidence interval and p-0.05 level of significance). Two sample student t-test will be used to do data analysis.

The measurement of Waste Anesthetic Gas in parts per million resolution emanating from the patient to the caregiver's breathing zone.

Outcome measures

Outcome measures
Measure	Standard Oxygen Mask n=56 Participants Standard face mask to provide supplemental oxygen Standard oxygen mask: Provide supplemental oxygen	ISO-Gard Mask n=52 Participants Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen. ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen
Waste Anesthetic Gas Measured by Parts Per Million Within PACU Caregiver's Breathing Zone With Caring for Patients	60.6 parts per million Standard Deviation 20.6	56.9 parts per million Standard Deviation 9.7

PRIMARY outcome

Timeframe: 1 hour post-operative recovery period

The measurement of Waste Anesthetic Gas in parts per million emanating from the patient between the standard oxygen mask and the ISO-Gard oxygen mask.

Outcome measures

Outcome measures
Measure	Standard Oxygen Mask n=56 Participants Standard face mask to provide supplemental oxygen Standard oxygen mask: Provide supplemental oxygen	ISO-Gard Mask n=52 Participants Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen. ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen
Waste Anesthetic Gas Measured by Parts Per Million Emanating From Patients During Normal PACU Working Conditions	58.7 parts per million Standard Deviation 8.1	56.7 parts per million Standard Deviation 10.2

PRIMARY outcome

Timeframe: 1 hour post-operative recovery period

For MAX-WAG measurements obtained every 30 seconds, we calculated the percentage of time in MAX-WAG \[\>2ppm\] relative to the total collection period.

Outcome measures

Outcome measures
Measure	Standard Oxygen Mask n=56 Participants Standard face mask to provide supplemental oxygen Standard oxygen mask: Provide supplemental oxygen	ISO-Gard Mask n=52 Participants Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen. ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen
Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Percentage of Time	5.2 percentage of time Interval 2.4 to 10.4	2.0 percentage of time Interval 0.0 to 5.7

PRIMARY outcome

Timeframe: 1 hour post-operative recovery period

For MAX-WAG measurements obtained every 30 seconds, we calculated the duration of MAX-WAG \[\>2ppm\]

Outcome measures

Outcome measures
Measure	Standard Oxygen Mask n=56 Participants Standard face mask to provide supplemental oxygen Standard oxygen mask: Provide supplemental oxygen	ISO-Gard Mask n=52 Participants Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen. ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen
Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Duration	3.0 minutes Interval 1.5 to 6.5	1.0 minutes Interval 0.0 to 3.0

Adverse Events

Standard Oxygen Mask

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ISO-Gard Mask

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

Thomas Philbeck, PhD, MBA, Senior Director of Global Research and Scientific Services

Teleflex

Phone: 210-581-7778

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60