Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

18 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

50

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Victor Caro-Frechilla, RN, MSc
  • Numero di telefono: +34 633809919
  • Email: vcaro@clinic.cat

Luoghi di studio

  • Spagna
    • Catalonia
      • Barcelona, Catalonia, Spagna, 08036
        • Hospital Clinic de Barcelona
        • Contatto:
          • Victor Caro-Frechilla, RN, MSc
          • Numero di telefono: +34 633809919
          • Email: vcaro@clinic.cat
        • Investigatore principale:
          • Victor Caro-Frechilla, RN, MSc
        • Sub-investigatore:
          • Ariadna Munne Zafra, RN, MSc
        • Sub-investigatore:
          • Fernando Javier Dana Muzzio, RN, MSc, PhD(c)
        • Sub-investigatore:
          • Jessica Martinez de la Mata, RN, MSc
        • Sub-investigatore:
          • Carla Murias Verdugo, RN

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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).
Altro: 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).
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Global Raw NASA-TLX Score
Lasso di tempo: 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 ).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
NASA-TLX Subscale Scores
Lasso di tempo: 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)
Lasso di tempo: 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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Alarm Management Behavior and Attention Interference During Intraoperative Care.
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hospital Clinic of Barcelona

Investigatori

  • Investigatore principale: Victor Caro-Frechilla, RN, MSc, Hospital Clinic of Barcelona

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

31 dicembre 2026

Completamento dello studio (Stimato)

1 gennaio 2027

Date di iscrizione allo studio

Primo inviato

28 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 aprile 2026

Primo Inserito (Effettivo)

5 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ENCOPER-HCB-2026-001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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.

Periodo di condivisione 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.

Criteri di accesso alla condivisione 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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su NASA Task Load Index (NASA-TLX)

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Malta

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi