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

Not Applicable

Completed

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

• Registration Number: NCT02428413
• Lead Sponsor: Teleflex

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-16
• Study First Submitted QC: 2015-04-22
• Study First Posted: 2015-04-28
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Results First Submitted: 2016-04-15
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-04
• Results First Posted: 2016-09-29
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard oxygen mask	Standard oxygen mask	Standard face mask to provide supplemental oxygen
ISO-Gard Mask	ISO-Gard Mask	Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.

Primary Outcome Measures

Name	Time	Method
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-Duration	1 hour post-operative recovery period	For MAX-WAG measurements obtained every 30 seconds, we calculated the duration of MAX-WAG \[\>2ppm\]
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.
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.