Waste Anesthetic Gas (WAG) Emanating From Patients Post-operative RecoveryNCT02428413

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

A study testing ISO-Gard Mask and Standard oxygen mask in people with Waste Anesthetic Gas (WAG) Emanating From Patients Post-operative Recovery, run by Teleflex.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Waste Anesthetic Gas (WAG) Emanating From Patients Post-operative Recovery
What is being tested?: ISO-Gard Mask and Standard oxygen mask
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 125 participants
Where: No sites listed yet
Study dates: Apr 2015to Dec 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:
. Bariatric procedures
Robotic surgery cases
Orthopedic

Show all 12Show fewer

Gynecological procedures
ENT
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).

Who cannot join

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

About this study

Official title: Evaluation and Control of Waste Anesthetic Gas (WAG) in the Post Anesthesia Care Unit (PACU) Within Patient and Caregiver Breathing Zone

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

Read the 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.

Conditions: Waste Anesthetic Gas (WAG) Emanating From Patients Post-operative Recovery
Being tested: ISO-Gard Mask, Standard oxygen mask
Keywords: Waste Anesthetic Gas (WAG)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ISO-Gard MaskDevice
to scavenge waste anesthetic gases from patients and provide supplemental oxygen
Standard oxygen maskDevice
Provide supplemental oxygen

Study groups in NCT02428413
Study group	Role	What they receive
Standard oxygen mask	Active comparator	Standard face mask to provide supplemental oxygen Receives: Device: Standard oxygen mask
ISO-Gard Mask	Active comparator	Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen. Receives: Device: ISO-Gard Mask

What is being measured

The primary outcome is the main question the study is designed to answer.

Waste Anesthetic Gas Measured by Parts Per Million Within PACU Caregiver's Breathing Zone With Caring for Patients
The measurement of Waste Anesthetic Gas in parts per million resolution emanating from the patient to the caregiver's breathing zone.
Measured: 1 hour post-operative recovery period
Waste Anesthetic Gas Measured by Parts Per Million Emanating From Patients During Normal PACU Working Conditions
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.
Measured: 1 hour post-operative recovery period
Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Percentage of Time
For MAX-WAG measurements obtained every 30 seconds, we calculated the percentage of time in MAX-WAG [>2ppm] relative to the total collection period.
Measured: 1 hour post-operative recovery period
Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Duration
For MAX-WAG measurements obtained every 30 seconds, we calculated the duration of MAX-WAG [>2ppm]
Measured: 1 hour post-operative recovery period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2015Dec 2015

First posted28 Apr 2015 (estimated)
Study startApr 2015
Primary completionNov 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Waste Anesthetic Gas (WAG) Emanating From Patients Post-operative RecoveryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 125 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02428413
Sponsor's protocol ID: 2015-05
Status last verified: Aug 2016
First submitted: 16 Apr 2015
Last updated: 25 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: The aggregate study results will be reported collectively, not individually by participant.

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation and Control of Waste Anesthetic Gas (WAG) in the Post Anesthesia Care Unit (PACU) Within Patient and Caregiver Breathing Zone
ClinicalTrials.gov ID: NCT02428413
Acronym / sponsor ID: 2015-05
Conditions: Waste Anesthetic Gas (WAG) Emanating From Patients Post-operative Recovery
Keywords: Waste Anesthetic Gas (WAG)
Study type: Interventional
Recruitment status: Completed
Enrolment: 125 participants (actual)
Lead sponsor: TeleflexIndustry (pharma, biotech, devices)
Study start: Apr 2015
Primary completion: Nov 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 28 Apr 2015 (estimated)
Results: Posted 29 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard oxygen mask	Active comparator	Device: Standard oxygen maskStandard face mask to provide supplemental oxygen
ISO-Gard Mask	Active comparator	Device: ISO-Gard MaskFace mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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:
Not documented as terminally ill
Subject expected to remain in PACU for at least one hour

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ISO-Gard Maskto scavenge waste anesthetic gases from patients and provide supplemental oxygen	Device	ISO-Gard Mask
Standard oxygen maskProvide supplemental oxygen	Device	Standard oxygen mask

Primary outcome

Waste Anesthetic Gas Measured by Parts Per Million Within PACU Caregiver's Breathing Zone With Caring for Patients
Time frame: 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.
Waste Anesthetic Gas Measured by Parts Per Million Emanating From Patients During Normal PACU Working Conditions
Time frame: 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.
Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Percentage of Time
Time frame: 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.
Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Duration
Time frame: 1 hour post-operative recovery period
For MAX-WAG measurements obtained every 30 seconds, we calculated the duration of MAX-WAG [>2ppm]

Results and safety

Results posted to the registry on 29 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Oxygen Mask	64	56
ISO-Gard Mask	61	52

Primary outcome: Waste Anesthetic Gas Measured by Parts Per Million Within PACU Caregiver's Breathing Zone With Caring for Patients

Time frame: 1 hour post-operative recovery period. Mean (Standard Deviation). Unit: parts per million

Measure	Standard Oxygen Mask n = 56	ISO-Gard Mask n = 52
Value	60.6 (20.6)	56.9 (9.7)

Standard Oxygen Mask vs ISO-Gard Mask: p = 0.24, t-test, 2 sided

Population analysed: 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.

Primary outcome: Waste Anesthetic Gas Measured by Parts Per Million Emanating From Patients During Normal PACU Working Conditions

Time frame: 1 hour post-operative recovery period. Mean (Standard Deviation). Unit: parts per million

Measure	Standard Oxygen Mask n = 56	ISO-Gard Mask n = 52
Value	58.7 (8.1)	56.7 (10.2)

Standard Oxygen Mask vs ISO-Gard Mask: p = 0.26, t-test, 2 sided

Primary outcome: Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Percentage of Time

Time frame: 1 hour post-operative recovery period. Median (Inter-Quartile Range). Unit: percentage of time

Measure	Standard Oxygen Mask n = 56	ISO-Gard Mask n = 52
Value	5.2 (2.4 to 10.4)	2.0 (0 to 5.7)

Primary outcome: Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Duration

Time frame: 1 hour post-operative recovery period. Median (Inter-Quartile Range). Unit: minutes

Measure	Standard Oxygen Mask n = 56	ISO-Gard Mask n = 52
Value	3.0 (1.5 to 6.5)	1.0 (0 to 3.0)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Oxygen Mask	0 of 56 (0%)	0 of 56 (0%)	Not reported
ISO-Gard Mask	0 of 52 (0%)	0 of 52 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. The aggregate study results will be reported collectively, not individually by participant.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

George W Williams III, MD principal investigator

U of Texas Medical school at Houston

Questions about this trial

What is this clinical trial studying?

A study testing ISO-Gard Mask and Standard oxygen mask in people with Waste Anesthetic Gas (WAG) Emanating From Patients Post-operative Recovery, run by Teleflex.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Waste Anesthetic Gas Measured by Parts Per Million Within PACU Caregiver's Breathing Zone With Caring for Patients (time frame: 1 hour post-operative recovery period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02428413.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.