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

Teleflex125 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

125

Conditions

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

Interventions

ISO-Gard MaskDEVICE

to scavenge waste anesthetic gases from patients and provide supplemental oxygen

Standard oxygen maskDEVICE

Provide supplemental oxygen

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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

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

Data from ClinicalTrials.gov

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