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Surgical Smoke ExposureNCT07830524

Preoperative Smoke Check and Surgical Smoke Evacuation Compliance

An observational study of Surgical Smoke Exposure, run by Volkan Gokmen at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Surgical Smoke Exposure
What is being tested?
Preoperative Smoke Check
How many people
300 participants
Where
1 siteTurkey (Türkiye)
Study dates
Oct 2026to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study 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.

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Volkan Gokmen, PhD contact

+90 532 739 0938

vgokmen@agri.edu.tr

Turkey (Türkiye)1 site
  • Agri Training and Research Hospital

    Ağrı

    Burcu Ozen Karabulut, MD, +90 472 215 6363, vgokmen@agri.edu.tr

    Volkan Gokmen, PhD

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of a Preoperative Smoke Check Practice on Compliance With Surgical Smoke Evacuation

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.

Read the detailed description

Background/Rationale: Surgical smoke is a mixture of particulate matter and gases generated by the use of energy-based devices (e.g., monopolar electrocautery, lasers) on tissue. Appropriate evacuation of surgical smoke at its source is an important safety practice to reduce unnecessary occupational and patient exposure. The AORN Guideline for Surgical Smoke Safety recommends that surgical smoke be captured as close as possible to its source and that an appropriate evacuation/filtration system be actively and continuously used whenever a smoke-generating energy device is activated, and that the evacuation system be ready for use before the procedure begins. In real clinical practice, however, smoke evacuation is not routinely or correctly used in every smoke-generating procedure. Reported barriers include failure to anticipate smoke generation in advance, unready equipment, delayed activation of the evacuation system, and lack of clearly assigned responsibility among perioperative staff for this task.

Aim: The aim of this study is to evaluate whether a brief, low-cost preoperative Smoke Check practice, consisting of two short safety questions asked by the circulating nurse before a procedure begins, increases the proportion of smoke-generating procedures in which surgical smoke evacuation is used appropriately.

Research Question: Does implementing a short, standardized preoperative Smoke Check increase appropriate use of surgical smoke evacuation in smoke-generating procedures, compared with current (baseline) practice?

Design: This is a single-center, prospective, quasi-experimental before-after (pre-post) study. In the first (Baseline) period, current smoke-evacuation practice will be observed in eligible procedures without any change to existing workflow. In the second (Post-Smoke Check) period, the Smoke Check will be added to the circulating nurses' existing preoperative workflow, consisting of two 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 same observation protocol will be used to assess smoke evacuation practice in both periods, and outcomes will be compared between periods.

Setting and Population: The study will be conducted at a single center, Ağrı Training and Research Hospital, between October 2026 and December 2026. The unit of analysis/observation is the surgical procedure (not the patient or staff member); eligible procedures are those in which surgical smoke generation is anticipated or observed due to the use of an energy-based device (e.g., monopolar electrocautery, bipolar, ultrasonic, or laser devices) in an open, laparoscopic/endoscopic, or other surgical approach. No patient- or staff-identifying information will be recorded; only a procedure research code will be used for data linkage.

Instruments/Data Collection: Two structured, non-validated, study-specific observation forms developed by the investigators will be used: (1) a Surgical Smoke Compliance Observation Form, used in both periods, to record the surgical branch, surgical approach, energy device used, whether visible surgical smoke occurred, whether the evacuation system was ready before the procedure began, whether it was used during energy device activation, whether the capture device was appropriately positioned near the smoke source, whether evacuation was sustained throughout the smoke-generating portion of the procedure, and an overall appropriate-use judgment; and (2) a Smoke Check Application Form, used only in the post-intervention period, to record whether the Smoke Check was completed, at what stage, and whether it caused any delay or required additional equipment. No licensed, validated, or psychometric scale or patient survey is used in this study; all measures are investigator-developed, guideline-based observational checklists.

Outcomes: The primary outcome is the proportion of smoke-generating procedures in which surgical smoke evacuation is used appropriately (defined as: the evacuation system was ready before the procedure, was actively used during energy device activation, the capture device was appropriately positioned near the smoke source, and evacuation was sustained for as long as clinically necessary). Secondary outcomes include: readiness of the smoke evacuation system before the procedure begins, appropriate positioning of the capture device relative to the smoke source, and continuity/duration of evacuation use throughout the smoke-generating portion of the procedure.

Statistical Analysis: Descriptive statistics will be used to summarize procedure and observation characteristics. The primary and secondary outcome proportions will be compared between the Baseline and Post-Smoke Check periods using chi-square or Fisher's exact test as appropriate, with a two-sided significance level of .05.

Difficulties and Limitations: As a single-center, non-randomized before-after design, the study is subject to potential confounding by time-related changes in staff, case mix, or other concurrent quality initiatives, and causal inference is limited compared with a randomized design. The use of non-validated, investigator-developed observation forms, rather than a licensed audit tool, is acknowledged as a limitation, although this reflects the pragmatic, guideline-based nature of the intervention. Because the unit of observation is the procedure, potential clustering of multiple observations from the same operating room or energy-device combination will be considered in the interpretation of results.

This research does not involve the administration of any investigational drug or device. It is registered as an observational study because procedures are not randomly assigned to an intervention as in a controlled interventional design; the Smoke Check practice-change is applied uniformly to workflow in the second period rather than randomized at the individual procedure level.

Being tested
Preoperative Smoke Check
Keywords
Surgical Smoke, Smoke Evacuation, Operating Room Nursing, Patient Safety, Staff Safety, Preoperative Checklist

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preoperative Smoke CheckOther

    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.

Study groups in NCT07830524
Study groupRoleWhat they receive
Baseline Period ProceduresSmoke-generating surgical procedures observed during the Baseline period (approximately 4 weeks), before the preoperative Smoke Check is introduced. Current smoke-evacuation practice is observed without any change to the existing workflow using the Surgical Smoke Compliance Observation Form. No intervention is applied to this group.
Post-Smoke Check Period ProceduresSmoke-generating surgical procedures observed during the second, approximately 4-week study period, after the preoperative Smoke Check has been introduced into the circulating nurses' preoperative workflow. In this period, the circulating nurse asks two short safety questions before the 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 same Surgical Smoke Compliance Observation Form used in the Baseline period is used to assess smoke evacuation practice, and a Smoke Check Application Form records completion of the Smoke Check.
Receives: Other: Preoperative Smoke Check

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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 (3)
  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.

    Measured: 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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07830524
Sponsor's protocol ID
AICU-SMOKECHECK-2026
Status last verified
Sep 2026
First submitted
15 Sep 2026
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No patient- or staff-identifying data are collected; observations are recorded using procedure-level research codes only. Given the observational, single-center nature of the study and the absence of individual participant identifiers, there is no individual participant dataset intended for external sharing at this time.

Publications

  • Surgical smoke knowledge and practices before and after onset of COVID-19. Perioperative Care and Operating Room Management. 2024;35:100411. doi:10.1016/j.pcorm.2024.100411

  • Dennis V. Needed Practice Change: Surgical Smoke Evacuation. AORN J. 2022 Aug;116(2):103-105. doi: 10.1002/aorn.13756. No abstract available.

    PubMed 35880930
  • Williams K. Guidelines in Practice: Surgical Smoke Safety. AORN J. 2022 Aug;116(2):145-159. doi: 10.1002/aorn.13745.

    PubMed 35880929
  • Ostapovych U, Vortman R. Implementing a Surgical Smoke Evacuation Policy and Procedure: A Quality Improvement Project. AORN J. 2022 Feb;115(2):139-146. doi: 10.1002/aorn.13603.

    PubMed 35084765
  • AORN Center of Excellence. Smoke Evacuation Resource Center: Compliance Audit Monitoring Tool. 2026.

  • Association of periOperative Registered Nurses (AORN). Guideline for Surgical Smoke Safety. AORN Guidelines for Perioperative Practice. 2026.

Questions about this trial

What is this clinical trial studying?

An observational study of Surgical Smoke Exposure, run by Volkan Gokmen at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Volkan Gokmen, PhD (+90 532 739 0938, vgokmen@agri.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Smoke-Generating Procedures with Appropriate Smoke Evacuation (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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07830524, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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