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

Teleflex

Status: Completed

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

Treatments: Device: Standard oxygen mask; Device: ISO-Gard Mask

Study type: Interventional

Funder types: Industry

Identifiers

NCT02428413

2015-05

Details and patient eligibility

About

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

Full 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.

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

125 participants in 2 patient groups

Standard oxygen mask

Active Comparator group

Description:

Standard face mask to provide supplemental oxygen

Treatment:

Device: Standard oxygen mask

ISO-Gard Mask

Active Comparator group

Description:

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

Treatment:

Device: ISO-Gard Mask