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Intraoperative Cognitive Load in Anesthesia Nurses Across Anesthetic Phases (ENCOPER)

10 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

50

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Victor Caro-Frechilla, RN, MSc
  • Numéro de téléphone: +34 633809919
  • E-mail: vcaro@clinic.cat

Lieux d'étude

  • Espagne
    • Catalonia
      • Barcelona, Catalonia, Espagne, 08036
        • Recrutement
        • Hospital Clinic de Barcelona
        • Contact:
          • Victor Caro-Frechilla, RN, MSc
          • Numéro de téléphone: +34 633809919
          • E-mail: vcaro@clinic.cat
        • Chercheur principal:
          • Victor Caro-Frechilla, RN, MSc
        • Sous-enquêteur:
          • Ariadna Munne Zafra, RN, MSc
        • Sous-enquêteur:
          • Fernando Javier Dana Muzzio, RN, MSc, PhD(c)
        • Sous-enquêteur:
          • Jessica Martinez de la Mata, RN, MSc
        • Sous-enquêteur:
          • Carla Murias Verdugo, RN

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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).
Autre: 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.
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).
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Global Raw NASA-TLX Score
Délai: 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.
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 ).

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
NASA-TLX Subscale Scores
Délai: 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.
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.
Monitor Alarm Perception Visual Analog Scale (VAS)
Délai: Assessed once per surgical case, immediately after patient awakening or sedation reversal, over approximately 8 months of data collection.
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.

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Alarm Management Behavior and Attention Interference During Intraoperative Care.
Délai: Perioperative - assessed once per surgical case, immediately after patient awakening or sedation reversal, over approximately 8 months of data collection.

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.
Estimated Percentage of Non-Actionable Monitor Alarms (P1)
Délai: Assessed once per surgical case, immediately after patient awakening or sedation reversal, over approximately 8 months of data collection.
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.
Assessed once per surgical case, immediately after patient awakening or sedation reversal, over approximately 8 months of data collection.
Patient Discharge Destination After Surgery
Délai: Assessed once per surgical case, at the end of the procedure before patient transfer, over approximately 8 months of data collection.
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/URPA), 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.
Airway Status at Operating Room Discharge
Délai: Assessed once per surgical case, immediately at the end of the procedure before patient transfer, over approximately 8 months of data collection.
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/VMNI). 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.
Patient Neurological Status at Operating Room Discharge
Délai: 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.
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 / Partial emergence; (4) No emergence / 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.
Case Completeness Status
Délai: Assessed once per surgical case, after data collection is complete for that case, over approximately 8 months of data collection.
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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hospital Clinic of Barcelona

Les enquêteurs

  • Chercheur principal: Victor Caro-Frechilla, RN, MSc, Hospital Clinic of Barcelona

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juin 2026

Achèvement primaire (Estimé)

28 février 2027

Achèvement de l'étude (Estimé)

28 février 2027

Dates d'inscription aux études

Première soumission

28 avril 2026

Première soumission répondant aux critères de contrôle qualité

28 avril 2026

Première publication (Réel)

5 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 juillet 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • ENCOPER-HCB-2026-001

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Délai de partage 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.

Critères d'accès au partage 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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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