Surgical smoke research

JRCT ID: jRCT1032240296

Registered date:26/08/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Patients undergoing general open surgery (excluding laparoscopic surgery) and breast surgery
• Date of first enrollment: 26/08/2024
• Target sample size: 120
• Countries of recruitment: none,Japan
• Study type: Observational

Intervention(s)

120 subjects are randomly assigned to three groups: a control group, a group using an aerosol collector and a group using drapes. Each will measure airborne fine particles at the anaesthetist's sitting position (1 m away from the patient's head and 1 m from the ground).
1, Control group: measure the number of fine particles in the air after use of the electrocautery.
2, Aerosol collector group: aerosol collector Free-100M (Forest One, Funabashi) with a virus removal filter for the suction of droplets containing aerosols and virus removal, with an artificial filter capable of removing 99.99% of viruses larger than 0.025 micro m. It has been shown in demonstration tests at the Kitasato Centre for Environmental Science to be useful for collecting, aspirating and removing aerosols, and is used clinically for oral care and upper gastrointestinal endoscopy. In addition, the variable arm supporting the aerosol collection aperture can be moved freely, enabling suction close to the source of contamination. The suction opening is positioned 30 cm above the patient in the aerosol collector group, the suction function is activated before the electrocautery is used and the number of fine particles in the air after the electrocautery is used is measured.
3, Drape group: a drape 2 m high and 2 m wide is placed between the surgical field and anaesthetist before the use of the electrocautery and the number of fine particles in the air after the use of the electrocautery is measured.

The measurement methods are Airborne particle counter Handheld 3016 (SGY Corporation, Tokyo) and Airborne particle counter Handheld 2016 (SGY Corporation, Tokyo) at the aforementioned positions and the number of aerosols dispersed during 30 seconds each. The Airborne particle counter Handheld 3016 measures fine particles of six different sizes (0.3, 0.5, 1.0, 2.5, 5.0 and 10 micro m), while the Airborne particle counter Handheld 2016 measures smaller diameter 0.2 micro m fine particles are counted simultaneously under air flow (28.3 L/min).

Outcome(s)

• Primary Outcome: Air particle counts during the use of electrocautery during surgical procedures.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients undergoing surgery under general anaesthesia are targeted. Among them, patients undergoing open surgery in general and breast surgery in particular are included.
• Exclude criteria: Excludes laparoscopic surgery.

Related Information

• Primary Sponsor: Asai Takashi
• Secondary ID(s): Nil known