[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656822":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":27,"studyPopulation":28,"armGroups":29,"interventions":38,"overallOfficials":43,"centralContacts":47,"locations":52,"responsibleParty":68,"collaborators":24,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":24,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":24,"maxAge":24,"enrollmentInfo":81,"targetDuration":24,"studyType":84,"phases":24,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":95,"whyStopped":24,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Agri Ibrahim Cecen University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"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.","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)",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"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.","Assessed at the time of each eligible procedure, over the ~8-week data collection period (October-December 2026)",{"measure":19,"description":20,"timeFrame":17},"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.",{"measure":22,"description":23,"timeFrame":17},"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.",null,{"allocation":24,"interventionModel":24,"interventionModelDescription":24,"primaryPurpose":24,"observationalModel":6,"timePerspective":26,"maskingInfo":24},"PROSPECTIVE","Background\u002FRationale: 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\u002Ffiltration 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.\n\nAim: 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.\n\nResearch 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?\n\nDesign: 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.\n\nSetting 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\u002Fobservation 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\u002Fendoscopic, or other surgical approach. No patient- or staff-identifying information will be recorded; only a procedure research code will be used for data linkage.\n\nInstruments\u002FData 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.\n\nOutcomes: 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\u002Fduration of evacuation use throughout the smoke-generating portion of the procedure.\n\nStatistical 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.\n\nDifficulties 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.\n\nThis 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.","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.",[30,33],{"label":31,"type":24,"description":32,"interventionNames":24},"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.",{"label":34,"type":24,"description":35,"interventionNames":36},"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.",[37],"Other: Preoperative Smoke Check",[39],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":24},"Preoperative Smoke Check","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\u002Fpractice-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.",[34],[44],{"name":45,"affiliation":5,"role":46},"Volkan Gokmen, PhD","PRINCIPAL_INVESTIGATOR",[48],{"name":45,"role":49,"phone":50,"phoneExt":24,"email":51},"CONTACT","+90 532 739 0938","vgokmen@agri.edu.tr",[53],{"facility":54,"status":24,"city":55,"state":24,"zip":24,"country":56,"countryCode":24,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Agri Training and Research Hospital","Ağrı","Turkey (Türkiye)",{"type":58,"coordinates":59},"Point",[60,61],43.04015,39.71467,{"lat":61,"lon":60},[64,67],{"name":65,"role":49,"phone":66,"phoneExt":24,"email":51},"Burcu Ozen Karabulut, MD","+90 472 215 6363",{"name":45,"role":46,"phone":24,"phoneExt":24,"email":24},{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Volkan Gokmen","Assistant Professor","100656822","preoperative-smoke-check-and-surgical-smoke-evacuation-compliance-100656822",false,"NCT07830524","Preoperative Smoke Check and Surgical Smoke Evacuation Compliance","The Effect of a Preoperative Smoke Check Practice on Compliance With Surgical Smoke Evacuation","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.\n\nInclusion Criteria:\n\n* Surgical procedures performed at Agri Training and Research Hospital during the designated Baseline Period or Post-Smoke Check Period data collection windows\n* Procedures utilizing an energy-based device (electrosurgery, laser, or ultrasonic device) capable of generating surgical smoke\n* 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\n\nExclusion Criteria:\n\n* Procedures not utilizing an energy-based device or not expected to generate surgical smoke\n* Emergency procedures in which direct, continuous observation of smoke evacuation practices was not feasible\n* Procedures with incomplete or missing observation data on the Surgical Smoke Compliance Observation Form",true,"ALL",{"count":82,"type":83},300,"ESTIMATED","OBSERVATIONAL","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.",[87],"Surgical Smoke Exposure",[89,90,91,92,93,94],"Surgical Smoke","Smoke Evacuation","Operating Room Nursing","Patient Safety","Staff Safety","Preoperative Checklist","NOT_YET_RECRUITING","2026-09-15",{"date":98,"type":99},"2026-09-21","ACTUAL",{"date":101,"type":83},"2026-10",{"date":103,"type":83},"2026-12",{"name":70,"class":6},1]