The Effect of a Preoperative Smoke Check Practice on Compliance With Surgical Smoke Evacuation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Proportion of Smoke-Generating Procedures with Appropriate Smoke Evacuation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Note: The unit of observation and analysis in this study is the surgical procedure, not the individual patient. The eligibility criteria below describe which surgical procedures were eligible for inclusion in observation and data collection.
- •Inclusion Criteria:
- •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
排除标准
- •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
研究组 & 干预措施
Baseline Period Procedures
Smoke-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 Procedures
Smoke-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.
干预措施: Preoperative Smoke Check (Other)
结局指标
主要结局
Proportion of Smoke-Generating Procedures with Appropriate Smoke Evacuation
时间窗: 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)
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.
次要结局
- Readiness of Smoke Evacuation System Before Procedure Start(Assessed at the time of each eligible procedure, over the ~8-week data collection period (October-December 2026))
- Appropriate Positioning of the Smoke Evacuation Capture Device(Assessed at the time of each eligible procedure, over the ~8-week data collection period (October-December 2026))
- Continuity of Smoke Evacuation Use Throughout the Procedure(Assessed at the time of each eligible procedure, over the ~8-week data collection period (October-December 2026))
研究者
Volkan Gokmen
Assistant Professor
Agri Ibrahim Cecen University