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Completed

NCT Number: NCT02428413

Evaluation and Control of WAG in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ISO-Gard Mask

Device

to scavenge waste anesthetic gases from patients and provide supplemental oxygen

Standard oxygen mask

Device

Provide supplemental oxygen

Primary outcomes

  1. Waste Anesthetic Gas Measured by Parts Per Million Within PACU Caregiver's Breathing Zone With Caring for Patients

    Time frame: 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.

  2. Waste Anesthetic Gas Measured by Parts Per Million Emanating From Patients During Normal PACU Working Conditions

    Time frame: 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.

  3. Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Percentage of Time

    Time frame: 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.

  4. Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Duration

    Time frame: 1 hour post-operative recovery period

    For MAX-WAG measurements obtained every 30 seconds, we calculated the duration of MAX-WAG [>2ppm]

Sponsors and collaborators

Lead sponsor

Teleflex

Industry

Registry information

Official study title

Evaluation and Control of Waste Anesthetic Gas (WAG) in the Post Anesthesia Care Unit (PACU) Within Patient and Caregiver Breathing Zone

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 28, 2015
Registry last updated
Nov 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.