Clinical trial NCT02428413: Evaluation and Control of WAG in PACU Within Patient and Caregiver Breathing Zone
Official title: Evaluation and Control of Waste Anesthetic Gas (WAG) in the Post Anesthesia Care Unit (PACU) Within Patient and Caregiver Breathing Zone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Waste Anesthetic Gas (WAG) Emanating From Patients Post-operative Recovery
Keywords: Waste Anesthetic Gas (WAG)
Lead sponsor: Teleflex
Sponsor class: INDUSTRY
First posted: 2015-04-28
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Waste Anesthetic Gas Measured by Parts Per Million Within PACU Caregiver's Breathing Zone With Caring for Patients
timeFrame: 1 hour post-operative recovery period
measure: Waste Anesthetic Gas Measured by Parts Per Million Emanating From Patients During Normal PACU Working Conditions
timeFrame: 1 hour post-operative recovery period
measure: Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Percentage of Time
timeFrame: 1 hour post-operative recovery period
measure: Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Duration
timeFrame: 1 hour post-operative recovery period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: U of Texas Medical school at Houston
name: George W Williams III, MD
role: PRINCIPAL_INVESTIGATOR
References: