N/A
N=125
Evaluation and Control of WAG in PACU Within Patient and Caregiver Breathing Zone
Waste Anesthetic Gas (WAG) Emanating From Patients Post-operative Recovery
Bottom Line
View on ClinicalTrials.gov: NCT02428413 ↗Enrolled (actual)
125
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcome: Primary: Waste Anesthetic Gas Measured by Parts Per Million Within PACU Caregiver's Breathing Zone With Caring for Patients — 60.6; 56.9 parts per million — p=0.24
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ISO-Gard Mask (Device); Standard oxygen mask (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Teleflex
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Waste Anesthetic Gas Measured by Parts Per Million Within PACU Caregiver's Breathing Zone With Caring for Patients |
60.6; 56.9 | 0.24 |
| PRIMARY Waste Anesthetic Gas Measured by Parts Per Million Emanating From Patients During Normal PACU Working Conditions |
58.7; 56.7 | 0.26 |
| PRIMARY Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Percentage of Time |
5.2; 2.0 | — |
| PRIMARY Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Duration |
3.0; 1.0 | — |
Summary
The purpose of this study is to evaluate anesthetic gas in the PACU within patient and caregiver breathing zones.
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:
- . Bariatric procedures
- Robotic surgery cases
- Orthopedic
- Gynecological procedures
- ENT
- 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
Data sourced from ClinicalTrials.gov (NCT02428413). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.