Intraoperative Cognitive Load in Anesthesia Nurses Across Anesthetic Phases (ENCOPER)
18. května 2026 aktualizováno: Víctor Caro, Hospital Clinic of Barcelona
Carga Cognitiva Intraoperatoria Del Enfermero/a de Anestesia Según la Fase Del Acto Anestésico: Estudio Observacional Con NASA-TLX
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:
- Does cognitive load vary across the three phases of anesthetic care (induction, maintenance, and emergence/recovery)?
- Is cognitive load higher during general anesthesia than during spinal anesthesia with sedation?
- How do surgical specialty and patient complexity relate to cognitive load?
- How does monitor alarm perception relate to cognitive load during surgery?
Participants (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.
Přehled studie
Postavení
Zatím nenabíráme
Intervence / Léčba
Detailní popis
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.
This 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/spinal block; T2: maintenance; T3: extubation/wake 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.
This is the first European study to measure cognitive load in anesthesia nurses using a validated instrument in a real surgical setting.
Typ studie
Pozorovací
Zápis (Odhadovaný)
50
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Victor Caro-Frechilla, RN, MSc
- Telefonní číslo: +34 633809919
- E-mail: vcaro@clinic.cat
Studijní místa
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Catalonia
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Barcelona, Catalonia, Španělsko, 08036
- Hospital Clinic de Barcelona
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Kontakt:
- Victor Caro-Frechilla, RN, MSc
- Telefonní číslo: +34 633809919
- E-mail: vcaro@clinic.cat
-
Vrchní vyšetřovatel:
- Victor Caro-Frechilla, RN, MSc
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Dílčí vyšetřovatel:
- Ariadna Munne Zafra, RN, MSc
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Dílčí vyšetřovatel:
- Fernando Javier Dana Muzzio, RN, MSc, PhD(c)
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Dílčí vyšetřovatel:
- Jessica Martinez de la Mata, RN, MSc
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Dílčí vyšetřovatel:
- Carla Murias Verdugo, RN
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
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.
Popis
Inclusion Criteria:
- Registered nurse anesthetist actively working at Hospital Clínic de Barcelona.
- Minimum 3 months in the current anesthesia nursing position.
- Voluntary participation with signed informed consent.
- Scheduled surgery (including deferred urgent surgery) or solid organ transplantation.
- General anesthesia (endotracheal intubation or laryngeal mask airway) or spinal anesthesia with sedation.
- Minimum duration of 30 minutes.
Exclusion Criteria:
- Refusal to participate or withdrawal of informed consent.
- Spinal anesthesia without sedation.
- Exclusive regional anesthesia without sedation.
- Sedation alone without regional technique.
- Duration less than 30 minutes.
- Cases involving an unexpected intraoperative emergency requiring urgent additional personnel.
- Cases started under spinal anesthesia converted to general anesthesia for any clinical or technical reason.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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).
|
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.
|
|
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).
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Global Raw NASA-TLX Score
Časové okno: At three time points per surgical case: T1 (5 minutes post-induction/spinal block), T2 (during maintenance, before surgical closure), and T3 (5 minutes after extubation/end of sedation ).
|
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.
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At three time points per surgical case: T1 (5 minutes post-induction/spinal block), T2 (during maintenance, before surgical closure), and T3 (5 minutes after extubation/end of sedation ).
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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NASA-TLX Subscale Scores
Časové okno: 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.
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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.
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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.
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Monitor Alarm Perception Visual Analog Scale (VAS)
Časové okno: Assessed once per surgical case, immediately after patient awakening or sedation reversal, over approximately 8 months of data collection.
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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.
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Alarm Management Behavior and Attention Interference During Intraoperative Care.
Časové okno: Perioperative - assessed once per surgical case, immediately after patient awakening or sedation reversal, over approximately 8 months of data collection.
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Two exploratory Likert-scale items (1-5) completed after patient awakening or sedation reversal per surgical case: Item 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. Item 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. Both 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.
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Victor Caro-Frechilla, RN, MSc, Hospital Clinic of Barcelona
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Cvach M. Monitor alarm fatigue: an integrative review. Biomed Instrum Technol. 2012 Jul-Aug;46(4):268-77. doi: 10.2345/0899-8205-46.4.268.
- Joint Commission. Medical device alarm safety in hospitals. Sentinel Event Alert. 2013 Apr 8;(50):1-3. No abstract available.
- ECRI Institute; Top 10 Health Technology Hazards for 2022; ECRI Institute; 2021
- Hart SG, Staveland LE; Development of NASA-TLX (Task Load Index): results of empirical and theoretical research; Advances in Psychology; 1988; 52; 139-183
- Sweller J; Cognitive load during problem solving: effects on learning; Cognitive Science; 1988; 12(2); 257-285
- Wunderlich CA, Barnsteiner JH, Minnick A; Development of the Clinical Alarm Fatigue Questionnaire (CAFQa); J Nurs Scholarsh; 2021; 53(6); 681-690
- Kennedy-Metz LR, Lehane CM, Yule S, Dias RD, Zenati MA; Measuring cognitive load in the cardiac operating room; J Thorac Cardiovasc Surg; 2020; 160(6); 1621-1630
- Piquilloud L, Tassaux D, Bialais E, Lambermont B, Roeseler J, Sottiaux T, Demoule A, Jolliet P; The work of breathing influences the cognitive load of nurses and physiotherapists during non-invasive ventilation assistance of patients with acute respiratory failure; Intensive Care Med; 2020; 46(5); 983-991
- Wickens CD. Multiple resources and mental workload. Hum Factors. 2008 Jun;50(3):449-55. doi: 10.1518/001872008X288394.
- Carayon P, Gurses AP. A human factors engineering conceptual framework of nursing workload and patient safety in intensive care units. Intensive Crit Care Nurs. 2005 Oct;21(5):284-301. doi: 10.1016/j.iccn.2004.12.003. Epub 2005 Feb 24.
- Reason J. Human error: models and management. BMJ. 2000 Mar 18;320(7237):768-70. doi: 10.1136/bmj.320.7237.768. No abstract available.
- Olin K, Goras C, Nilsson U, Unbeck M, Ehrenberg A, Pukk-Harenstam K, Ekstedt M. Mapping registered nurse anaesthetists' intraoperative work: tasks, multitasking, interruptions and their causes, and interactions: a prospective observational study. BMJ Open. 2022 Jan 19;12(1):e052283. doi: 10.1136/bmjopen-2021-052283.
- Goras C, Olin K, Unbeck M, Pukk-Harenstam K, Ehrenberg A, Tessma MK, Nilsson U, Ekstedt M. Tasks, multitasking and interruptions among the surgical team in an operating room: a prospective observational study. BMJ Open. 2019 May 15;9(5):e026410. doi: 10.1136/bmjopen-2018-026410.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. června 2026
Primární dokončení (Odhadovaný)
31. prosince 2026
Dokončení studie (Odhadovaný)
1. ledna 2027
Termíny zápisu do studia
První předloženo
28. dubna 2026
První předloženo, které splnilo kritéria kontroly kvality
28. dubna 2026
První zveřejněno (Aktuální)
5. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
20. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
18. května 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ENCOPER-HCB-2026-001
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
Individual participant data (IPD) to be shared includes the anonymized case-level dataset containing: NASA-TLX subscale scores (T1, T2, T3), surgical case characteristics (anesthetic technique, surgical specialty, ASA, duration), and exploratory alarm management variables (VAS, P1, P2, P3).
Participant-level data (experience, training) will be included in anonymized form.
No directly identifiable information will be shared.
Časový rámec sdílení IPD
IPD and supporting documents will be available starting 6 months after publication of the primary results article (estimated 2027-2028) and will remain available for 5 years.
Kritéria přístupu pro sdílení IPD
IPD will be available upon reasonable request to the principal investigator (vcaro@clinic.cat).
Requestors must provide: (1) a brief description of the proposed use, (2) institutional affiliation, and (3) agreement to data use conditions.
Data will be shared as anonymized datasets in CSV format.
No individual participant can be identified from the shared data.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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