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The purpose of this study is to evaluate anesthetic gas in the PACU within patient and caregiver breathing zones.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard oxygen mask | Active Comparator | Standard face mask to provide supplemental oxygen |
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| ISO-Gard Mask | Active Comparator | Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ISO-Gard Mask | Device | to scavenge waste anesthetic gases from patients and provide supplemental oxygen |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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] | 1 hour post-operative recovery period |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| George W Williams III, MD | U of Texas Medical school at Houston | Principal Investigator |
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The aggregate study results will be reported collectively, not individually by participant.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Oxygen Mask | Standard face mask to provide supplemental oxygen Standard oxygen mask: Provide supplemental oxygen |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Oxygen Mask | Standard face mask to provide supplemental oxygen Standard oxygen mask: Provide supplemental oxygen |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | parts per million | 1 hour post-operative recovery period |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Oxygen Mask | Standard face mask to provide supplemental oxygen Standard oxygen mask: Provide supplemental oxygen |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Philbeck, PhD, MBA, Senior Director of Global Research and Scientific Services | Teleflex | 210-581-7778 | thomas.philbeck@teleflex.com |
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| Standard oxygen mask | Device | Provide supplemental oxygen |
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| Case Cancelled |
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| Missed Cases |
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| Nurse Refusal |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 |
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|
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| Primary | 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. | Posted | Mean | Standard Deviation | parts per million | 1 hour post-operative recovery period |
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| Primary | 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. | Posted | Median | Inter-Quartile Range | percentage of time | 1 hour post-operative recovery period |
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| Primary | 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] | Posted | Median | Inter-Quartile Range | minutes | 1 hour post-operative recovery period |
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| 0 |
| 56 |
| 0 |
| 56 |
| EG001 | 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 | 0 | 52 | 0 | 52 |
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