Intraoperative Cognitive Load in Anesthesia Nurses Across Anesthetic Phases (ENCOPER)
2026년 7월 10일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
관찰
등록 (추정된)
50
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Victor Caro-Frechilla, RN, MSc
- 전화번호: +34 633809919
- 이메일: vcaro@clinic.cat
연구 장소
-
-
Catalonia
-
Barcelona, Catalonia, 스페인, 08036
- 모병
- Hospital Clinic de Barcelona
-
연락하다:
- Victor Caro-Frechilla, RN, MSc
- 전화번호: +34 633809919
- 이메일: vcaro@clinic.cat
-
수석 연구원:
- Victor Caro-Frechilla, RN, MSc
-
부수사관:
- Ariadna Munne Zafra, RN, MSc
-
부수사관:
- Fernando Javier Dana Muzzio, RN, MSc, PhD(c)
-
부수사관:
- Jessica Martinez de la Mata, RN, MSc
-
부수사관:
- Carla Murias Verdugo, RN
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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).
|
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).
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Global Raw NASA-TLX Score
기간: 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 ).
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
NASA-TLX Subscale Scores
기간: 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)
기간: 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.
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Alarm Management Behavior and Attention Interference During Intraoperative Care.
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Victor Caro-Frechilla, RN, MSc, Hospital Clinic of Barcelona
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
- Joint Commission. Medical device alarm safety in hospitals. Sentinel Event Alert. 2013 Apr 8;(50):1-3. No abstract available.
- 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
- Sweller J; Cognitive load during problem solving: effects on learning; Cognitive Science; 1988; 12(2); 257-285
- Wunderlich CA, Barnsteiner JH, Minnick A; Development of the Clinical Alarm Fatigue Questionnaire (CAFQa); J Nurs Scholarsh; 2021; 53(6); 681-690
- Kennedy-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
- Wickens CD. Multiple resources and mental workload. Hum Factors. 2008 Jun;50(3):449-55. doi: 10.1518/001872008X288394.
- 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.
- 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.
- 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.
- Goras 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 6월 1일
기본 완료 (추정된)
2027년 2월 28일
연구 완료 (추정된)
2027년 2월 28일
연구 등록 날짜
최초 제출
2026년 4월 28일
QC 기준을 충족하는 최초 제출
2026년 4월 28일
처음 게시됨 (실제)
2026년 5월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 10일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ENCOPER-HCB-2026-001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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.
IPD 공유 기간
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.
IPD 공유 액세스 기준
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.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .