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Recruiting NCT07568158

Intraoperative Cognitive Load in Anesthesia Nurses Across Anesthetic Phases

— Observational Alarm Fatigue Perioperative Patient Safety Cognitive Load

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NASA Task Load Index (NASA-TLX).
Who it may be relevant to
Registry conditions: Alarm Fatigue, Perioperative, Patient Safety, Cognitive Load. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other 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.

Primary outcome measures

  • 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 ).]
Secondary outcome measures (2)
  • 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.]
  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • Hospital Clínic de Barcelona — Barcelona

Publications

  • Joint Commission. Medical device alarm safety in hospitals. Sentinel Event Alert. 2013 Apr 8;(50):1-3. No abstract available. PMID 23767076
  • 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
  • Wickens CD. Multiple resources and mental workload. Hum Factors. 2008 Jun;50(3):449-55. doi: 10.1518/001872008X288394. PMID 18689052
  • Sweller J; Cognitive load during problem solving: effects on learning; Cognitive Science; 1988; 12(2); 257-285
  • 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. PMID 16182125
  • 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. PMID 10720363
  • Wunderlich CA, Barnsteiner JH, Minnick A; Development of the Clinical Alarm Fatigue Questionnaire (CAFQa); J Nurs Scholarsh; 2021; 53(6); 681-690

Identifiers

NCT: NCT07568158 · ENCOPER-HCB-2026-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗