Waste Anesthetic Gas (WAG) Emanating From Patients Post-operative Recovery
Conditions
Keywords
Waste Anesthetic Gas (WAG)
Brief summary
The purpose of this study is to evaluate anesthetic gas in the PACU within patient and caregiver breathing zones.
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.
Interventions
DEVICEISO-Gard Mask
to scavenge waste anesthetic gases from patients and provide supplemental oxygen
DEVICEStandard oxygen mask
Provide supplemental oxygen
Sponsors
Teleflex
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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 \[\>2ppm\] |
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.
Participants by arm
| Arm | Count |
|---|---|
| Standard Oxygen Mask Standard face mask to provide supplemental oxygen
Standard oxygen mask: Provide supplemental oxygen | 56 |
| 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 | 52 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Case Cancelled | 2 | 0 |
| Overall Study | Device to measure WAG malfunctioned | 3 | 5 |
| Overall Study | Missed Cases | 1 | 2 |
| Overall Study | Nurse Refusal | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 2 |
Baseline characteristics
| Characteristic | Standard Oxygen Mask | ISO-Gard Mask | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 10 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 42 Participants | 91 Participants |
| Sex: Female, Male Female | 41 Participants | 28 Participants | 69 Participants |
| Sex: Female, Male Male | 15 Participants | 24 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 56 | 0 / 52 |
| serious Total, serious adverse events | 0 / 56 | 0 / 52 |
Outcome results
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 \[\>2ppm\]
Time frame: 1 hour post-operative recovery period
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Oxygen Mask | Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Duration | 3.0 minutes |
| ISO-Gard Mask | Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Duration | 1.0 minutes |
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.
Time frame: 1 hour post-operative recovery period
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Oxygen Mask | Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Percentage of Time | 5.2 percentage of time |
| ISO-Gard Mask | Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Percentage of Time | 2.0 percentage of time |
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.
Time frame: 1 hour post-operative recovery period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Oxygen Mask | 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 |
| ISO-Gard Mask | Waste Anesthetic Gas Measured by Parts Per Million Emanating From Patients During Normal PACU Working Conditions | 56.7 parts per million | Standard Deviation 10.2 |
p-value: 0.26t-test, 2 sided
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Oxygen Mask | 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 |
| ISO-Gard Mask | Waste Anesthetic Gas Measured by Parts Per Million Within PACU Caregiver's Breathing Zone With Caring for Patients | 56.9 parts per million | Standard Deviation 9.7 |
p-value: 0.24t-test, 2 sided