The Effect of Masks on Surgical Smoke Exposure

Mersin University

Status: Not yet enrolling

Conditions: Surgical Smoke

Treatments: Device: Particle counter

Study type: Interventional

Funder types: Other

Identifiers

NCT07161609

Different Types of Masks

Details and patient eligibility

About

Surgical smoke refers to the gaseous plume released into the air as a result of the thermal destruction of tissues by energy-based devices used in operating rooms. The composition of surgical smoke may include various organic compounds. In the literature, the most frequently identified chemical substances in surgical smoke are formaldehyde, acrolein, hydrocarbons, fatty acids, hydrocyanic acid, phenols, nitriles, acrylonitrile, hydrogen cyanide, benzene, and toluene. These particles can negatively affect the health of the operating room personnel. According to current guidelines, masks are recommended as the primary personal protective equipment to prevent respiratory exposure associated with surgical smoke. During surgical procedures, operating room staff frequently use surgical masks. Although surgical masks are the most commonly preferred personal protective equipment to protect healthcare workers against microorganisms and aerosols, they are unfortunately ineffective in filtering small particles. Therefore, the present study aimed to determine the impact of different types of masks on exposure to surgical smoke.

Full description

With the advancement of surgical techniques, the instruments and devices used in surgery have also rapidly evolved. Among these are energy-based devices that produce heat to achieve dissection or hemostasis during surgical procedures. Surgical smoke refers to the gaseous plume released into the air as a result of the thermal destruction of tissues by such devices, and is also termed cautery smoke, smoke plume, aerosol, or bioaerosol. While approximately 95% of surgical smoke consists of water vapor, the remaining 5% contains dead and viable cellular material, blood particles, viruses, bacteria, and toxic gases. The quantity and particle size of surgical smoke vary depending on factors such as the type of energy source, the tissue treated, and the duration and extent of treatment.

Surgical smoke has been identified by professional associations as a chemical hazard affecting the safety of operating room environments. Larger particles (≥5 μm) deposit in the nasal and oropharyngeal regions, particles of 2-5 μm can reach the airways, and particles <2 μm may penetrate lung tissue, accumulating in bronchioles and alveoli. Various toxic chemicals have been identified in surgical smoke, including formaldehyde, acrolein, hydrocarbons, fatty acids, hydrogen cyanide, phenols, nitriles, acrylonitrile, benzene, and toluene. Studies have also reported the presence of volatile organic compounds such as toluene, xylene, ethylbenzene, styrene, and naphthalene, with concentrations varying by procedure type.

Exposure to surgical smoke negatively impacts the health of operating room staff, with reported symptoms such as headaches, nausea, throat irritation, cough, eye problems, respiratory difficulties, dermatitis, and anxiety. To mitigate these risks, recommended measures include staff education, awareness programs, installation of smoke evacuation systems, use of personal protective equipment, and development of institutional protocols.

Among personal protective equipment, masks are the primary barrier recommended against respiratory exposure to surgical smoke. Although surgical masks are widely used to protect healthcare professionals against microorganisms and aerosols, they are largely ineffective in filtering fine particles. Professional guidelines advise the use of N95 respirators in conjunction with smoke evacuation systems, especially in procedures with high risk of viral transmission, given their superior filtration capacity.

However, studies specifically examining the effectiveness of different types of masks against surgical smoke remain limited, with most research focusing on mask performance during the COVID-19 pandemic. Experimental studies comparing filtration efficiency have demonstrated superior performance of N95/FFP2 respirators compared to surgical masks. In this context, the present study aims to investigate the effectiveness of different mask types in protecting operating room staff from surgical smoke exposure.

Enrollment: 60 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Use of electrocautery,
• Duration of surgery longer than 2 hours,
• Elective total or partial hip prosthesis procedures.

Exclusion criteria

• No use of electrocautery,
• Duration of surgery shorter than 2 hours,
• Emergency total or partial hip prosthesis procedures.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Single surgical mask

Experimental group

Description:

During the surgery of patients undergoing hip prosthesis, an air sample will be collected to determine the particle count by attaching a single surgical mask to the tip of the particle counter.

Treatment:

Device: Particle counter

Double surgical mask

Experimental group

Description:

During the surgery of patients undergoing hip prosthesis, an air sample will be collected to determine the particle count by attaching a double surgical mask to the tip of the particle counter.

Treatment:

Device: Particle counter

N95 mask

Experimental group

Description:

During the surgery of patients undergoing hip prosthesis, an air sample will be collected to determine the particle count by attaching a N95 surgical mask to the tip of the particle counter.

Treatment:

Device: Particle counter