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

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.

Study Overview

• Status: Completed
• Conditions: Waste Anesthetic Gas (WAG) Emanating From Patients Post-operative Recovery
• Intervention / Treatment: Device: Standard oxygen mask; Device: ISO-Gard Mask

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 Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: April 16, 2015
• First Submitted That Met QC Criteria: April 22, 2015
• First Posted (ESTIMATE): April 28, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): November 25, 2016
• Last Update Submitted That Met QC Criteria: October 12, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Waste Anesthetic Gas (WAG)
• Other Study ID Numbers: 2015-05 (APHM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The aggregate study results will be reported collectively, not individually by participant.