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Preoperative Smoke Check and Surgical Smoke Evacuation Compliance

ConditionSurgical Smoke Exposure
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorVolkan Gokmen

About this trial

This single-center, prospective before-after (quasi-experimental) study evaluates whether a brief preoperative "Smoke Check" practice improves compliance with surgical smoke evacuation during smoke-generating surgical procedures. The Smoke Check consists of two short safety questions asked by the circulating nurse before a procedure begins: (1) Is surgical smoke expected to be generated during this procedure? and (2) If yes, is an appropriate smoke evacuation system ready for use? The study first observes current practice during a Baseline period without changing existing workflow, and then introduces the Smoke Check into the circulating nurses' preoperative routine during a second (Post-Smoke Check) period, comparing the proportion of smoke-generating procedures with appropriate smoke evacuation use between the two periods. The unit of observation is the surgical procedure, not the patient or staff member, and no patient- or staff-identifying information is collected. The study is grounded in the Association of periOperative Registered Nurses (AORN) Guideline for Surgical Smoke Safety and does not involve any drug, device, or licensed psychometric instrument.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Surgical procedures performed at Agri Training and Research Hospital during the designated Baseline Period or Post-Smoke Check Period data collection windows

Procedures utilizing an energy-based device (electrosurgery, laser, or ultrasonic device) capable of generating surgical smoke

Procedures for which smoke evacuation practices could be directly and continuously observed by the study's trained observer for the full duration of the procedure

Disqualifiers

Procedures not utilizing an energy-based device or not expected to generate surgical smoke

Emergency procedures in which direct, continuous observation of smoke evacuation practices was not feasible

Procedures with incomplete or missing observation data on the Surgical Smoke Compliance Observation Form

Trial population

Surgical procedures performed at Agri Training and Research Hospital involving use of an energy-based device (electrosurgery, laser, or ultrasonic device) with observable surgical smoke generation. Procedures are evaluated during a Baseline Period (no intervention) and a subsequent Post-Smoke Check Period (Preoperative Smoke Check practice applied), rather than being defined by individual patient characteristics.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Preoperative Smoke Check

    Other intervention

    A brief, standardized preoperative safety check performed by the circulating nurse before a procedure begins, consisting of two short questions: (1) "Is surgical smoke expected to be generated during this procedure?" and (2) "If yes, is an appropriate smoke evacuation system ready for use?" The Smoke Check does not add any new drug, device, or equipment; it is a workflow/practice-change integrated into the existing preoperative routine, based on the AORN Guideline for Surgical Smoke Safety, and is applied only during the Post-Smoke Check study period.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Baseline Period Procedures0 interventions
Group B: Post-Smoke Check Period Procedures1 intervention

Trial outcomes

Primary outcomes

1

Proportion of Smoke-Generating Procedures with Appropriate Smoke Evacuation

Percentage of observed surgical procedures using an energy-based device (electrosurgery, laser, or ultrasonic device) in which surgical smoke evacuation equipment is used appropriately, as documented on the Surgical Smoke Compliance Observation Form, compared between the Baseline Period and the Post-Smoke Check Period.

Time frame
Assessed for each eligible procedure at the time of the procedure, over the approximately 8-week data collection period (approximately 4 weeks Baseline Period and approximately 4 weeks Post-Smoke Check Period, October-December 2026)

Secondary outcomes

1

Readiness of Smoke Evacuation System Before Procedure Start

Percentage of observed procedures in which the smoke evacuation system is confirmed ready (powered on, tubing connected, filter in place) before the procedure begins, as documented on the Surgical Smoke Compliance Observation Form.

Time frame
Assessed at the time of each eligible procedure, over the ~8-week data collection period (October-December 2026)
2

Appropriate Positioning of the Smoke Evacuation Capture Device

Percentage of observed procedures in which the smoke evacuation capture device (source-capture tip or wand) is positioned appropriately close to the smoke source throughout the procedure, as documented on the Surgical Smoke Compliance Observation Form.

Time frame
Assessed at the time of each eligible procedure, over the ~8-week data collection period (October-December 2026)
3

Continuity of Smoke Evacuation Use Throughout the Procedure

Percentage of observed procedures in which surgical smoke evacuation is used continuously for the full duration of smoke-generating activity, without interruption or premature discontinuation, as documented on the Surgical Smoke Compliance Observation Form.

Time frame
Assessed at the time of each eligible procedure, over the ~8-week data collection period (October-December 2026)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Volkan Gokmen

Lead sponsor

Agri Ibrahim Cecen University

Sponsor institution

Source ClinicalTrials.gov

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