Operating Room Air Filtration/Sterilization

NCT ID: NCT04610294

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

66273 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2026-12-31

Brief Summary

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Determine whether operating room air filtration and sterilization with the ActivePure system reduces a composite of serious surgical site infections, infection-related complications, and death within 30 days after surgery.

Detailed Description

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The investigators primary goal is thus to determine whether supplemental filtering and sterilizing operating room air reduces a composite of serious surgical site infections, infection-related complications, and death within 30 days after surgery. The primary outcome will be restricted to inpatients. However, outpatients will be simultaneously enrolled given the trial's cluster design. Sample-size is based on our primary inpatient analysis, N= 66,273 inpatients. Available outpatients will be included for analysis of our secondary outcome which includes both inpatients and outpatients.

Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized multiple crossover cluster trial
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Identical-looking test devices are either active or inactive. None of the investigators, clinicians, patients, or outcome assessors knows which are which.

Study Groups

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Aerus air sterilization

Aerus air sterilization system will be used in an operating room, in addition to routine room air filtration

Group Type EXPERIMENTAL

Functioning Aerus air filtration/sterilization

Intervention Type DEVICE

Two units of Aerus air sterilization system will be used in each operating room, and each will be set to "high." Units used for the trial will be modified internally to be active and will be sealed to prevent operating room personnel from opening the system and determining a unit's status.

Conventional air handling

Only routine room air filtration will be used in an operation room.

Group Type ACTIVE_COMPARATOR

Deactivated Aerus air filtration/sterilization

Intervention Type DEVICE

Two units of Aerus air sterilization system will be used in each operating room, and each will be set to "high." Units used for the trial will be modified internally to be inactivated and will be sealed to prevent operating room personnel from opening the system and determining a unit's status. Units will be inactivated by removing the activated carbon, high-efficiency particulate filter, and ionization chamber. However, the fan will remain active as will the "run" lights.

Interventions

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Functioning Aerus air filtration/sterilization

Two units of Aerus air sterilization system will be used in each operating room, and each will be set to "high." Units used for the trial will be modified internally to be active and will be sealed to prevent operating room personnel from opening the system and determining a unit's status.

Intervention Type DEVICE

Deactivated Aerus air filtration/sterilization

Two units of Aerus air sterilization system will be used in each operating room, and each will be set to "high." Units used for the trial will be modified internally to be inactivated and will be sealed to prevent operating room personnel from opening the system and determining a unit's status. Units will be inactivated by removing the activated carbon, high-efficiency particulate filter, and ionization chamber. However, the fan will remain active as will the "run" lights.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients in designated adult operating rooms
* American Society of Anesthesiologists physical status 1-4.
* Surgery lasting at least 1 hour.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel I Sessler, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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20-656

Identifier Type: -

Identifier Source: org_study_id

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