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NCT Number: NCT07568158

Intraoperative Cognitive Load in Anesthesia Nurses Across Anesthetic Phases

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínic de Barcelona

Barcelona, Catalonia, 08036, Spain

Location status: Recruiting

Location contact

Ariadna Munne Zafra, RN, MSc

SUB_INVESTIGATOR

Carla Murias Verdugo, RN

SUB_INVESTIGATOR

Fernando Javier Dana Muzzio, RN, MSc, PhD(c)

SUB_INVESTIGATOR

Jessica Martinez de la Mata, RN, MSc

SUB_INVESTIGATOR

Victor Caro-Frechilla, RN, MSc

CONTACT

[email protected]

+34 633809919

Victor Caro-Frechilla, RN, MSc

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NASA Task Load Index (NASA-TLX)

Other

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.

Primary outcomes

  1. Global Raw NASA-TLX Score

    Time frame: 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.

Secondary outcomes

  1. NASA-TLX Subscale Scores

    Time frame: 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.

  2. Monitor Alarm Perception Visual Analog Scale (VAS)

    Time frame: 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).

Other outcomes

  1. Alarm Management Behavior and Attention Interference During Intraoperative Care.

    Time frame: 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.

  2. Estimated Percentage of Non-Actionable Monitor Alarms (P1)

    Time frame: 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.

  3. Patient Discharge Destination After Surgery

    Time frame: 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.

  4. Airway Status at Operating Room Discharge

    Time frame: 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.

  5. Patient Neurological Status at Operating Room Discharge

    Time frame: 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.

  6. Case Completeness Status

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Victor Caro-Frechilla, RN, MSc

CONTACT

[email protected]

+34 633809919

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

Carga Cognitiva Intraoperatoria Del Enfermero/a de Anestesia Según la Fase Del Acto Anestésico: Estudio Observacional Con NASA-TLX

Acronym: ENCOPER

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 5, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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