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

NCT02428413 | Completed Results

• 1 other identifier: 2015-05
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate anesthetic gas in the PACU within patient and caregiver breathing zones.

Conditions

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

Keywords

Waste Anesthetic Gas (WAG)

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Standard oxygen mask

ACTIVE COMPARATOR

Standard face mask to provide supplemental oxygen

Device: Standard oxygen mask

ISO-Gard Mask

ACTIVE COMPARATOR

Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.

Device: ISO-Gard Mask

Interventions

ISO-Gard Mask DEVICE

to scavenge waste anesthetic gases from patients and provide supplemental oxygen

ISO-Gard Mask

Standard oxygen mask DEVICE

Provide supplemental oxygen

Standard oxygen mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Teleflex: lead

Limitations and Caveats

Precise dosing of anesthetic gas was not recorded. Dosing is practitioner dependent. Duration of surgery, PACU nurse interactions with patients, including proximity, attention to patient, and number of patients.

Results Point of Contact

• Title: Thomas Philbeck, PhD, MBA, Senior Director of Global Research and Scientific Services
• Organization: Teleflex

thomas.philbeck@teleflex.com

210-581-7778

Study Officials

• George W Williams III, MD

  U of Texas Medical school at Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: April 28, 2015
• Study Start: April 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 25, 2016
• Results First Posted: September 29, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share