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

• Sponsor: Teleflex (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02428413
• Collaborator: (none)
• Enrollment: 125
• Arms: 2
• Duration (Months): 8

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate anesthetic gas in the PACU within patient and caregiver breathing zones.

Condition or Disease	Intervention/Treatment	Phase
Waste Anesthetic Gas (WAG) Emanating From Patients Post-operative Recovery	Device: ISO-Gard Mask; Device: Standard oxygen mask	N/A

Detailed Description

The purpose of this single-center, multi-arm, randomized controlled study is to evaluate use of the ISO-Gard mask in patients immediately following a surgical procedure in which inhaled anesthetic is used as the primary modality of anesthesia, for the following: 1) measure the waste anesthetic gas emanating from patient during the immediate one hour post-operative recovery period in the PACU; 2) measure waste anesthetic gas within PACU caregiver's breathing zone; and 3) determine the efficacy of the ISO-Gard mask in reducing caregiver's exposure to waste anesthetic gas in the PACU.

Subjects who will receive either Sevoflurane or Desflurane inhaled anesthetic will be enrolled in this study. Subjects will be randomized to receive either the ISO-Gard scavenging mask or a traditional supplemental oxygen mask post operatively; all other elements of the subjects' care will be in accordance with the institution's standard of care.

Study Design

• Study Type: Interventional
• Actual Enrollment: 125 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: Evaluation and Control of Waste Anesthetic Gas (WAG) in the Post Anesthesia Care Unit (PACU) Within Patient and Caregiver Breathing Zone
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard oxygen mask Standard face mask to provide supplemental oxygen	Device: Standard oxygen mask; Provide supplemental oxygen
Active Comparator: ISO-Gard Mask Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.	Device: ISO-Gard Mask; to scavenge waste anesthetic gases from patients and provide supplemental oxygen

Outcome Measures

Primary Outcome Measures

1. Waste Anesthetic Gas Measured by Parts Per Million Within PACU Caregiver's Breathing Zone With Caring for Patients [1 hour post-operative recovery period]

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

2. Waste Anesthetic Gas Measured by Parts Per Million Emanating From Patients During Normal PACU Working Conditions [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.

3. Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Percentage of Time [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.

4. Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Duration [1 hour post-operative recovery period]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject is 18-120 years of age.

• Patients requiring inhaled anesthetic agents as part of their anesthesia during surgery (Sevoflurane or Desflurane)

• Patients with following outpatient procedures scheduled for a duration of greater than 2 hours per the operating room schedule:

1. . Bariatric procedures

2. Robotic surgery cases

3. Orthopedic

4. Gynecological procedures

5. ENT

6. Plastic

• Not documented as terminally ill

• Subject expected to remain in PACU for at least one hour

• Subject or legally authorized representative has provided written informed consent prior to the procedure using a form that is approved by the Institutional Review Board (IRB).

Exclusion Criteria:

• Patients are/were given/planned to be given total IV anesthetics during surgery

• Any patient that is not expected to tolerate a mask in PACU

• Subject has already been enrolled in study

• Subject is an employee of the Investigator or has involvement in other studies under the direction of investigator or study site

• Women who are pregnant

• End of anesthetic gas administration in PACU bay greater than 45 minutes

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Teleflex

Investigators

• Principal Investigator: George W Williams III, MD, U of Texas Medical school at Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Teleflex
• ClinicalTrials.gov Identifier: NCT02428413
• Other Study ID Numbers: 2015-05
• First Posted: Apr 28, 2015
• Last Update Posted: Nov 25, 2016
• Last Verified: Aug 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Teleflex: Waste Anesthetic Gas (WAG)

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Standard Oxygen Mask	ISO-Gard Mask
Arm/Group Description	Standard face mask to provide supplemental oxygen Standard oxygen mask: Provide supplemental oxygen	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
Period Title: Overall Study
STARTED	64	61
COMPLETED	56	52
NOT COMPLETED	8	9

Baseline Characteristics

Arm/Group Title	Standard Oxygen Mask	ISO-Gard Mask	Total
Arm/Group Description	Standard face mask to provide supplemental oxygen Standard oxygen mask: Provide supplemental oxygen	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 of all reporting groups
Overall Participants	56	52	108
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	49 87.5%	42 80.8%	91 84.3%
>=65 years	7 12.5%	10 19.2%	17 15.7%
Sex: Female, Male (Count of Participants)
Female	41 73.2%	28 53.8%	69 63.9%
Male	15 26.8%	24 46.2%	39 36.1%

Outcome Measures

1. Primary Outcome

Title	Waste Anesthetic Gas Measured by Parts Per Million Within PACU Caregiver's Breathing Zone With Caring for Patients
Description	The measurement of Waste Anesthetic Gas in parts per million resolution emanating from the patient to the caregiver's breathing zone.
Time Frame	1 hour post-operative recovery period

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Standard Oxygen Mask	ISO-Gard Mask
Arm/Group Description	Standard face mask to provide supplemental oxygen Standard oxygen mask: Provide supplemental oxygen	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
Measure Participants	56	52
Mean (Standard Deviation) [parts per million]	60.6 (20.6)	56.9 (9.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Oxygen Mask, ISO-Gard Mask
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.24
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Waste Anesthetic Gas Measured by Parts Per Million Emanating From Patients During Normal PACU Working Conditions
Description	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.
Time Frame	1 hour post-operative recovery period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Oxygen Mask	ISO-Gard Mask
Arm/Group Description	Standard face mask to provide supplemental oxygen Standard oxygen mask: Provide supplemental oxygen	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
Measure Participants	56	52
Mean (Standard Deviation) [parts per million]	58.7 (8.1)	56.7 (10.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Oxygen Mask, ISO-Gard Mask
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.26
	Comments
	Method	t-test, 2 sided
	Comments

3. Primary Outcome

Title	Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Percentage of Time
Description	For MAX-WAG measurements obtained every 30 seconds, we calculated the percentage of time in MAX-WAG [>2ppm] relative to the total collection period.
Time Frame	1 hour post-operative recovery period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Oxygen Mask	ISO-Gard Mask
Arm/Group Description	Standard face mask to provide supplemental oxygen Standard oxygen mask: Provide supplemental oxygen	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
Measure Participants	56	52
Median (Inter-Quartile Range) [percentage of time]	5.2	2.0

4. Primary Outcome

Title	Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Duration
Description	For MAX-WAG measurements obtained every 30 seconds, we calculated the duration of MAX-WAG [>2ppm]
Time Frame	1 hour post-operative recovery period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Oxygen Mask	ISO-Gard Mask
Arm/Group Description	Standard face mask to provide supplemental oxygen Standard oxygen mask: Provide supplemental oxygen	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
Measure Participants	56	52
Median (Inter-Quartile Range) [minutes]	3.0	1.0

Adverse Events

Arm/Group Title	Standard Oxygen Mask		ISO-Gard Mask
Arm/Group Description	Standard face mask to provide supplemental oxygen Standard oxygen mask: Provide supplemental oxygen		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
All Cause Mortality
	Standard Oxygen Mask		ISO-Gard Mask
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard Oxygen Mask		ISO-Gard Mask
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/52 (0%)
Other (Not Including Serious) Adverse Events
	Standard Oxygen Mask		ISO-Gard Mask
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/52 (0%)

Limitations/Caveats

Precise dosing of anesthetic gas was not recorded. Dosing is practitioner dependent. Duration of surgery, PACU nurse interactions with patients, including proximity, attention to patient, and number of patients.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.