MedDataX Logo

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

NCT ID: NCT02428413

Last Updated: 2016-11-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Waste Anesthetic Gas (WAG)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard oxygen mask

Standard face mask to provide supplemental oxygen

Group Type ACTIVE_COMPARATOR

Standard oxygen mask

Intervention Type DEVICE

Provide supplemental oxygen

ISO-Gard Mask

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

Group Type ACTIVE_COMPARATOR

ISO-Gard Mask

Intervention Type DEVICE

to scavenge waste anesthetic gases from patients and provide supplemental oxygen

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ISO-Gard Mask

to scavenge waste anesthetic gases from patients and provide supplemental oxygen

Intervention Type DEVICE

Standard oxygen mask

Provide supplemental oxygen

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Teleflex

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

George W Williams III, MD

Role: PRINCIPAL_INVESTIGATOR

U of Texas Medical school at Houston

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015-05

Identifier Type: -

Identifier Source: org_study_id