Intraoperative Cognitive Load in Anesthesia Nurses Across Anesthetic Phases (ENCOPER)
2026年7月10日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (推定)
50
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Victor Caro-Frechilla, RN, MSc
- 電話番号：+34 633809919
- メール：vcaro@clinic.cat
研究場所
-
-
Catalonia
-
Barcelona、Catalonia、スペイン、08036
- 募集
- Hospital Clinic de Barcelona
-
コンタクト：
- Victor Caro-Frechilla, RN, MSc
- 電話番号：+34 633809919
- メール：vcaro@clinic.cat
-
主任研究者：
- Victor Caro-Frechilla, RN, MSc
-
副調査官：
- Ariadna Munne Zafra, RN, MSc
-
副調査官：
- Fernando Javier Dana Muzzio, RN, MSc, PhD(c)
-
副調査官：
- Jessica Martinez de la Mata, RN, MSc
-
副調査官：
- Carla Murias Verdugo, RN
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Global Raw NASA-TLX Score
時間枠：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 ).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
NASA-TLX Subscale Scores
時間枠：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)
時間枠：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.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Alarm Management Behavior and Attention Interference During Intraoperative Care.
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Victor Caro-Frechilla, RN, MSc、Hospital Clinic of Barcelona
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月1日
一次修了 (推定)
2027年2月28日
研究の完了 (推定)
2027年2月28日
試験登録日
最初に提出
2026年4月28日
QC基準を満たした最初の提出物
2026年4月28日
最初の投稿 (実際)
2026年5月5日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月13日
QC基準を満たした最後の更新が送信されました
2026年7月10日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ENCOPER-HCB-2026-001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
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 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。