[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054043":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":50,"studyPopulation":51,"armGroups":52,"interventions":62,"overallOfficials":67,"centralContacts":71,"locations":76,"responsibleParty":103,"collaborators":47,"id":106,"slug":47,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":113,"sex":114,"minAge":115,"maxAge":47,"enrollmentInfo":116,"targetDuration":119,"studyType":120,"phases":47,"briefSummary":121,"conditions":122,"keywords":129,"overallStatus":79,"whyStopped":47,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Hospital Clinic of Barcelona","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Global Raw NASA-TLX Score","Subjective cognitive load measured using the Raw NASA Task Load Index (NASA-TLX), calculated as the arithmetic mean of six subscales (mental demand, physical demand, temporal demand, performance, effort, and frustration), each rated on a 0-100 scale. Administered three times per surgical case: after induction or spinal block (T1), during maintenance (T2), and after extubation or end of sedation (T3). Study duration: approximately 8 months.","At three time points per surgical case: T1 (5 minutes post-induction\u002Fspinal block), T2 (during maintenance, before surgical closure), and T3 (5 minutes after extubation\u002Fend of sedation ).",[14,18],{"measure":15,"description":16,"timeFrame":17},"NASA-TLX Subscale Scores","Individual scores for each of the six NASA-TLX subscales (mental demand, physical demand, temporal demand, performance, effort, and frustration), each rated on a 0-100 scale, to identify which dimensions of cognitive load predominate at each anesthetic phase.","Assessed at three intraoperative time points per surgical case: 5 minutes post-induction or post-spinal block, during maintenance before surgical closure, and 5 minutes post-extubation or end of sedation, over approximately 8 months of data collection.",{"measure":19,"description":20,"timeFrame":21},"Monitor Alarm Perception Visual Analog Scale (VAS)","Exploratory measure of nurses' perceived alarm burden during each surgical case, rated on a visual analog scale from 0 (not at all) to 100 (extremely). Assessed after patient awakening or sedation reversal. Used to explore the association between alarm perception and cognitive load (NASA-TLX score).","Assessed once per surgical case, immediately after patient awakening or sedation reversal, over approximately 8 months of data collection.",[23,27,30,34,38,42],{"measure":24,"description":25,"timeFrame":26},"Alarm Management Behavior and Attention Interference During Intraoperative Care.","Two exploratory Likert-scale items (1-5) completed after patient awakening or sedation reversal per surgical case:\n\nItem 1 (Alarm Evaluation Behavior): \"Non-urgent alarms have been clinically evaluated before silencing or ignoring them\" (1 = Never, 5 = Always). Assesses whether nurses evaluate alarms before acting on them.\n\nItem 2 (Alarm Interference with Attention): \"Monitor alarms have interfered with my ability to pay attention to the patient during this case\" (1 = Never, 5 = Always). Assesses the perceived impact of alarms on patient-focused attention.\n\nBoth items are exploratory given the absence of a validated alarm fatigue instrument in Spanish. Results will be presented with descriptive statistics and Spearman correlations with NASA-TLX scores.","Perioperative - assessed once per surgical case, immediately after patient awakening or sedation reversal, over approximately 8 months of data collection.",{"measure":28,"description":29,"timeFrame":21},"Estimated Percentage of Non-Actionable Monitor Alarms (P1)","Exploratory measure of nurses' perception of non-actionable monitor alarms per surgical case. After patient awakening or sedation reversal, nurses estimate the percentage of alarms that did NOT require immediate clinical action, using four categories: less than 25%, 25-50%, 51-75%, or more than 75%. Used to explore the association between alarm burden and cognitive load (NASA-TLX score). Assessed given the absence of a validated alarm fatigue instrument in Spanish.",{"measure":31,"description":32,"timeFrame":33},"Patient Discharge Destination After Surgery","Categorization of the patient's discharge destination at the end of the surgical procedure, as recorded by the anesthesia nurse: Post-Anesthesia Care Unit (PACU\u002FURPA), Intensive Care Unit (ICU), Intermediate Care Unit, or General Ward (Hospitalization). Used as a contextual variable to characterize case complexity and patient severity in relation to cognitive load.","Assessed once per surgical case, at the end of the procedure before patient transfer, over approximately 8 months of data collection.",{"measure":35,"description":36,"timeFrame":37},"Airway Status at Operating Room Discharge","Categorization of the patient's airway management status at the end of the surgical procedure, as recorded by the anesthesia nurse. Four categories: (1) Endotracheal intubation (ETT) - patient transferred intubated; (2) Extubated - no respiratory support; (3) Extubated with Venturi mask (VMK); (4) Extubated with non-invasive mechanical ventilation (NIV\u002FVMNI). Used as a contextual variable characterizing the clinical complexity of the emergence phase in relation to cognitive load.","Assessed once per surgical case, immediately at the end of the procedure before patient transfer, over approximately 8 months of data collection.",{"measure":39,"description":40,"timeFrame":41},"Patient Neurological Status at Operating Room Discharge","Categorization of the patient's neurological and behavioral status at discharge from the operating room, as recorded by the anesthesia nurse. Only assessed for extubated patients. Four categories: (1) Awake and cooperative; (2) Awake and agitated; (3) Drowsy \u002F Partial emergence; (4) No emergence \u002F Unresponsive. Used as a contextual variable characterizing the clinical complexity of the T3 phase in relation to cognitive load.","Assessed once per surgical case, immediately at the end of the procedure before patient transfer. Only recorded for extubated patients, over approximately 8 months of data collection.",{"measure":43,"description":44,"timeFrame":45},"Case Completeness Status","Operational classification of each surgical case data collection record, assessed by the investigator: (1) Complete - all three NASA-TLX phases (T1, T2, T3) and alarm management variables were collected; (2) Incomplete - one or more phases were not collected due to clinical circumstances but the case is included in partial analyses; (3) Drop-out - the case is excluded from all analyses, with the reason documented (e.g., intraoperative emergency, protocol deviation, participant withdrawal). Used to track data quality and guide the missing data management strategy.","Assessed once per surgical case, after data collection is complete for that case, over approximately 8 months of data collection.",{"allocation":47,"interventionModel":47,"interventionModelDescription":47,"primaryPurpose":47,"observationalModel":48,"timePerspective":49,"maskingInfo":47},null,"COHORT","PROSPECTIVE","Anesthesia nurses manage up to 72 tasks per hour during surgical procedures, including vital sign monitoring, drug administration, airway management, alarm response, and surgical team coordination. Despite this high workload, the cognitive load of anesthesia nurses has received little scientific attention. Most studies focus on simulation rather than real clinical settings.\n\nThis prospective observational study uses the Raw NASA Task Load Index (NASA-TLX) to quantify subjective cognitive load in anesthesia nurses across three phases of anesthetic care (T1: post-induction\u002Fspinal block; T2: maintenance; T3: extubation\u002Fwake up), comparing general anesthesia (endotracheal intubation or laryngeal mask) versus spinal anesthesia with sedation. Additionally, an exploratory module examines nurses' perception and management of monitor alarms and its association with cognitive load.\n\nThis is the first European study to measure cognitive load in anesthesia nurses using a validated instrument in a real surgical setting.","Registered nurse anesthetists actively working at Hospital Clínic de Barcelona, a university tertiary care hospital, assigned to the following operating rooms: main surgical block, ambulatory surgery unit (CMA), interventional radiology suite (RIO), DIVAS intraoperative radiotherapy unit, and transplant operating room.",[53,58],{"label":54,"type":47,"description":55,"interventionNames":56},"General Anesthesia (GA)","Anesthesia nurses managing surgical cases under general anesthesia (endotracheal intubation or laryngeal mask airway). Cognitive load measured at three phases: post-induction (T1), maintenance (T2), and post-extubation (T3).",[57],"Other: NASA Task Load Index (NASA-TLX)",{"label":59,"type":47,"description":60,"interventionNames":61},"Spinal Anesthesia with Sedation","Anesthesia nurses managing surgical cases under spinal anesthesia combined with intravenous sedation. Cognitive load measured at three phases: post-spinal block and sedation initiation (T1), maintenance (T2), and end of sedation (T3).",[57],[63],{"type":6,"name":64,"description":65,"armGroupLabels":66,"otherNames":47},"NASA Task Load Index (NASA-TLX)","The Raw NASA Task Load Index (NASA-TLX) is a validated self-report questionnaire measuring subjective cognitive load across six dimensions: mental demand, physical demand, temporal demand, performance, effort, and frustration (scale 0-100). Administered three times per surgical case (T1, T2, T3) by the participating anesthesia nurse. Additionally, four questions about monitor alarm perception and management are completed after T3.",[54,59],[68],{"name":69,"affiliation":5,"role":70},"Victor Caro-Frechilla, RN, MSc","PRINCIPAL_INVESTIGATOR",[72],{"name":69,"role":73,"phone":74,"phoneExt":47,"email":75},"CONTACT","+34 633809919","vcaro@clinic.cat",[77],{"facility":78,"status":79,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"Hospital Clínic de Barcelona","RECRUITING","Barcelona","Catalonia","08036","Spain","ES",{"type":86,"coordinates":87},"Point",[88,89],2.15899,41.38879,{"lat":89,"lon":88},[92,93,94,97,99,101],{"name":69,"role":73,"phone":74,"phoneExt":47,"email":75},{"name":69,"role":70,"phone":47,"phoneExt":47,"email":47},{"name":95,"role":96,"phone":47,"phoneExt":47,"email":47},"Ariadna Munne Zafra, RN, MSc","SUB_INVESTIGATOR",{"name":98,"role":96,"phone":47,"phoneExt":47,"email":47},"Fernando Javier Dana Muzzio, RN, MSc, PhD(c)",{"name":100,"role":96,"phone":47,"phoneExt":47,"email":47},"Jessica Martinez de la Mata, RN, MSc",{"name":102,"role":96,"phone":47,"phoneExt":47,"email":47},"Carla Murias Verdugo, RN",{"type":70,"investigatorFullName":104,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":47,"oldOrganization":47},"Víctor Caro","Registered Nurse Anesthetist","100054043",false,"NCT07568158","Intraoperative Cognitive Load in Anesthesia Nurses Across Anesthetic Phases","Carga Cognitiva Intraoperatoria Del Enfermero\u002Fa de Anestesia Según la Fase Del Acto Anestésico: Estudio Observacional Con NASA-TLX","ENCOPER","Inclusion Criteria:\n\n* Registered nurse anesthetist actively working at Hospital Clínic de Barcelona.\n* Minimum 3 months in the current anesthesia nursing position.\n* Voluntary participation with signed informed consent.\n* Scheduled surgery (including deferred urgent surgery) or solid organ transplantation.\n* General anesthesia (endotracheal intubation or laryngeal mask airway) or spinal anesthesia with sedation.\n* Minimum duration of 30 minutes.\n\nExclusion Criteria:\n\n* Refusal to participate or withdrawal of informed consent.\n* Spinal anesthesia without sedation.\n* Exclusive regional anesthesia without sedation.\n* Sedation alone without regional technique.\n* Duration less than 30 minutes.\n* Cases involving an unexpected intraoperative emergency requiring urgent additional personnel.\n* Cases started under spinal anesthesia converted to general anesthesia for any clinical or technical reason.",true,"ALL","18 Years",{"count":117,"type":118},50,"ESTIMATED","8 Months","OBSERVATIONAL","The goal of this observational study is to measure the cognitive load (mental effort) of anesthesia nurses during real surgical procedures at Hospital Clínic de Barcelona, Spain. The main questions it aims to answer are:\n\n* Does cognitive load vary across the three phases of anesthetic care (induction, maintenance, and emergence\u002Frecovery)?\n* Is cognitive load higher during general anesthesia than during spinal anesthesia with sedation?\n* How do surgical specialty and patient complexity relate to cognitive load?\n* How does monitor alarm perception relate to cognitive load during surgery?\n\nParticipants (anesthesia nurses) will complete the NASA Task Load Index (NASA-TLX) questionnaire - a validated 6-item tool measuring mental effort - three times per surgical case: after induction or spinal block, during maintenance, and after patient awakening or sedation reversal. They will also answer 4 brief questions about alarm management at the end of each case. No changes are made to clinical care. Participation adds approximately 11 minutes per surgical case.",[123,124,125,126,127,128],"Alarm Fatigue","Perioperative","Patient Safety","Cognitive Load","Performance","Cognitive Load, Performance",[130,131,132,133,134,125,135,136],"NASA-TLX","Anesthesia Nursing","Perioperative Nursing","Mental Workload","Intraoperative","Monitor Alarms","Operating Room","2026-07-10",{"date":139,"type":140},"2026-07-13","ACTUAL",{"date":142,"type":140},"2026-06-01",{"date":144,"type":118},"2027-02-28",{"name":5,"class":6},1]