Alarm FatigueENCOPERNCT07568158
Intraoperative Cognitive Load in Anesthesia Nurses Across Anesthetic Phases
An observational study of Alarm Fatigue and Perioperative, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alarm Fatigue, Perioperative, Patient Safety
- What is being tested?
- NASA Task Load Index (NASA-TLX)
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2026to 28 Feb 2027
- How long will I take part?
- 8 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona, Catalonia, 08036
Victor Caro-Frechilla, RN, MSc, +34 633809919, vcaro@clinic.cat
Victor Caro-Frechilla, RN, MSc
About this study
Official title: 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.
Read the 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.
- Conditions
- Alarm Fatigue, Perioperative, Patient Safety, Cognitive Load, Performance, Cognitive Load, Performance
- Being tested
- NASA Task Load Index (NASA-TLX)
- Keywords
- NASA-TLX, Anesthesia Nursing, Perioperative Nursing, Mental Workload, Intraoperative, Patient Safety, Monitor Alarms, Operating Room
- Medical subject headings
- Alert Fatigue, Health Personnel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: NASA Task Load Index (NASA-TLX) | |
| 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). Receives: Other: NASA Task Load Index (NASA-TLX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Raw NASA-TLX Score
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.
Measured: 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 outcomes (2)
NASA-TLX Subscale Scores
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.
Measured: 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)
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).
Measured: Assessed once per surgical case, immediately after patient awakening or sedation reversal, over approximately 8 months of data collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start1 Jun 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Alarm FatigueStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Víctor Caro, Hospital Clinic of Barcelona
- Investigators
- Victor Caro-Frechilla, RN, MSc, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568158
- Sponsor's protocol ID
- ENCOPER-HCB-2026-001
- Acronym
- ENCOPER
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Joint Commission. Medical device alarm safety in hospitals. Sentinel Event Alert. 2013 Apr 8;(50):1-3. No abstract available.
PubMed 23767076ECRI 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.
PubMed 18689052Sweller 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.
PubMed 16182125Reason J. Human error: models and management. BMJ. 2000 Mar 18;320(7237):768-70. doi: 10.1136/bmj.320.7237.768. No abstract available.
PubMed 10720363Wunderlich CA, Barnsteiner JH, Minnick A; Development of the Clinical Alarm Fatigue Questionnaire (CAFQa); J Nurs Scholarsh; 2021; 53(6); 681-690
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.
PubMed 22839984Kennedy-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
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.
PubMed 35045998Goras 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.
PubMed 31097486
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carga Cognitiva Intraoperatoria Del Enfermero/a de Anestesia Según la Fase Del Acto Anestésico: Estudio Observacional Con NASA-TLX
- ClinicalTrials.gov ID
- NCT07568158
- Acronym / sponsor ID
- ENCOPER / ENCOPER-HCB-2026-001
- Conditions
- Alarm Fatigue, Perioperative, Patient Safety, Cognitive Load, Performance, Cognitive Load, Performance
- Keywords
- NASA-TLX, Anesthesia Nursing, Perioperative Nursing, Mental Workload, Intraoperative, Patient Safety, Monitor Alarms, Operating Room
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia (GA) | – | Other: NASA Task Load Index (NASA-TLX)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). |
| Spinal Anesthesia with Sedation | – | Other: NASA Task Load Index (NASA-TLX)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | General Anesthesia (GA), Spinal Anesthesia with Sedation |
Primary outcome
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.
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background: PubMed 23767076Joint Commission. Medical device alarm safety in hospitals. Sentinel Event Alert. 2013 Apr 8;(50):1-3. No abstract available.
- BackgroundECRI Institute; Top 10 Health Technology Hazards for 2022; ECRI Institute; 2021
- BackgroundHart SG, Staveland LE; Development of NASA-TLX (Task Load Index): results of empirical and theoretical research; Advances in Psychology; 1988; 52; 139-183
- Background: PubMed 18689052Wickens CD. Multiple resources and mental workload. Hum Factors. 2008 Jun;50(3):449-55. doi: 10.1518/001872008X288394.
- BackgroundSweller J; Cognitive load during problem solving: effects on learning; Cognitive Science; 1988; 12(2); 257-285
- Background: PubMed 16182125Carayon 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.
- Background: PubMed 10720363Reason J. Human error: models and management. BMJ. 2000 Mar 18;320(7237):768-70. doi: 10.1136/bmj.320.7237.768. No abstract available.
- BackgroundWunderlich CA, Barnsteiner JH, Minnick A; Development of the Clinical Alarm Fatigue Questionnaire (CAFQa); J Nurs Scholarsh; 2021; 53(6); 681-690
- Background: PubMed 22839984Cvach 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.
- BackgroundKennedy-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
- BackgroundPiquilloud 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
- Background: PubMed 35045998Olin 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.
- NASA Task Load Index (NASA-TLX) official resourceLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victor Caro-Frechilla, RN, MSc principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alarm Fatigue and Perioperative, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victor Caro-Frechilla, RN, MSc (+34 633809919, vcaro@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 ).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07568158, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.