Impact of a Day Without Clinical Activity Before Night Shift on Non-technical Skills of Intensive Care Residents (REPOPREGARD)
2021年11月23日 更新者：University Hospital, Clermont-Ferrand
Impact of a Modified Schedule Including a Day Without Clinical Activity Before Night Shift on Non-technical Skills of French Residents in Intensive Care Unit, a Prospective Randomized Multi Center Study: REPOPREGARD Protocol Study
In this proposal, investigators seek to address conclusively two knowledge gaps: 1) the lack of data on the impact of a schedule including a day off clinic before night shift on performances of residents in anesthesia or critical care medicine and 2) the lack of data on the relationship between resident sleep deprivation and their non technical skills impairment. Investigators designed a prospective, randomized, blinded in cross over evaluation of medical pratices. Investigators will compare resident's performance during a high fidelity simulation session, on crisis managment in intensive care unit, after a night shift in intensive care unit, of residents who work on an intervention schedule with no clinical activity before night shift, with resident's performance of residents who had a traditionnal schedule including an usual clinical day before night shift. Investigators also assess cognitive performances, sleepiness and self esteem before and after night shift. Investigators specific aims will be:
To test the hypothesis that residents working on an intervention schedule will have non technical skills, assessed by Ottawa GRS global score, significantly less impaired after a night shift, than those on traditionnal schedule
To test the hypothesis that residents working on an interveniton schedule will have cognitive performances, sleepiness and self esteem less impaired after night shift than those on a traditionnal schedule
調査の概要
状態
まだ募集していません
条件
詳細な説明
Main objective of this study is to compare the non-technical skills after night shift, of anaesthesia and critical care residents who did not have clinical activity before the night shift with those who had at least 8 hours of clinical activity before.
The workforce is constrained by the number of residents in training at Clermont-Ferrand and Lyon University Public Hospital.
Thus, it is possible to consider the inclusion of 60 residents for 55 evaluable.
With such numbers, the clinically relevant difference of 6 points for the Ottawa GRS score (for a standard deviation of 11) can be demonstrated with an alpha risk of bilateral error of 5% and a power of 80%.
Two interim analyzes will be carried out including the first 20 interns and then 20 additional interns (therefore for 40 interns) with the aim of stopping the study for "effectiveness", more precisely stopping the study for evidence of a statistically significant difference for the primary outcome measure, with risks of first error observed respectively at 0.0005 and 0.014 comparisons (correction due to multiples).
A simulation of the statistical power will also be proposed during the performance of these analyzes; if necessary, a new estimation of the workforce will be proposed to the competent authorities.
Investigators do not plan loss of follow up.
研究の種類
観察的
入学 (予想される)
60
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。
研究場所
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Clermont-Ferrand、フランス、63000
- Clermont-Ferrand University Hospital
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主任研究者：
- Alexandre LAUTRETTE
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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
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
The investigators will include volunteer residents in anesthesia of critical care medicine of Gabriel Montpied university hospital of Clermont Ferrand.
説明
Inclusion Criteria:
- residents in Anesthesia or Critical care medicine
- Who effect night shift in intensive care unit
- Able to take a day off clinic before night shift
- Able to give consent
Exclusion Criteria:
- Refusal of participation
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 |
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Control
Residents in control group have a usual day with clinical activity before night shift
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Intervention
Residents in intervention group have a day off clinic before night shift (i.e day off or day with university activity)
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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 |
|---|---|---|
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Residents' non technical skills after a night shift
時間枠：Immediatly after the end of the night shift
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Measured by Ottawa Global Rated Scale global score assessed during a high fidelity simulation session of crisis managment.
Global score is comprise between 7 for a performance expected from a beginner and 42 for a performance expeted from an expert.
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Immediatly after the end of the night shift
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Residents' non technical skill before a night shift
時間枠：Baseline, before the night shift
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Measured by Ottawa Global Rated Scale global score assessed during a high fidelity simulation session of crisis managment.
Global score is comprise between 7 for a performance expected from a beginner and 42 for a performance expeted from an expert.
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Baseline, before the night shift
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Cognitive performances : Phasic alert test
時間枠：Before the night shift
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refers to the notion of general wakefulness allowing to react quickly and appropriately to requests, score obtained from computer tool
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Before the night shift
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Cognitive performances : Phasic alert test
時間枠：After the night shift up to 12 hours
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refers to the notion of general wakefulness allowing to react quickly and appropriately to requests, score obtained from computer tool
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After the night shift up to 12 hours
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Cognitive performances : Divided attention test
時間枠：Before the night shift
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refers to the notion of paying attention to several things at the same time, score obtained from computer tool
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Before the night shift
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Cognitive performances : Divided attention test
時間枠：After the night shift up to 12 hours
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refers to the notion of paying attention to several things at the same time, score obtained from computer tool
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After the night shift up to 12 hours
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Cognitive performances : Flexibility test with alternation
時間枠：Before the night shift
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refers to the notion of displacement of the attentional focus, score obtained from computer tool
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Before the night shift
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Cognitive performances : Flexibility test with alternation
時間枠：After the night shift up to 12 hours
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refers to the notion of displacement of the attentional focus, score obtained from computer tool
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After the night shift up to 12 hours
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Cognitive performances : Working memory test
時間枠：Before the night shift
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refers to the notion of maintaining and updating when carrying out complex problems, score obtained from computer tool
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Before the night shift
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Cognitive performances : Working memory test
時間枠：After the night shift up to 12 hours
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refers to the notion of maintaining and updating when carrying out complex problems, score obtained from computer tool
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After the night shift up to 12 hours
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Cognitive performances : Computerized Speed Cognitive Test
時間枠：Before the night shift
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refers to the notion of the speed of information processing, score obtained from computer tool
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Before the night shift
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Cognitive performances : Computerized Speed Cognitive Test
時間枠：After the night shift up to 12 hours
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refers to the notion of the speed of information processing, score obtained from computer tool
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After the night shift up to 12 hours
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Sleepiness
時間枠：Before the night shift
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Measured by Karolinska Sleepiness scale, a score of 1 for a great tiredness to 9 for a very well awake state.
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Before the night shift
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Sleepiness
時間枠：After the night shift up to 12 hours
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Measured by Karolinska Sleepiness scale, a score of 1 for a great tiredness to 9 for a very well awake state.
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After the night shift up to 12 hours
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Self esteem
時間枠：Before the night shift
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Measured by Rosenberg Self Esteem scale, a score lower than 25 indicates a low self esteem and a score higher than 39 indicates a high self esteem.
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Before the night shift
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Self esteem
時間枠：After the night shift up to 12 hours
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Measured by Rosenberg Self Esteem scale, a score lower than 25 indicates a low self esteem and a score higher than 39 indicates a high self esteem.
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After the night shift up to 12 hours
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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。
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 (予想される)
2021年12月1日
一次修了 (予想される)
2023年6月1日
研究の完了 (予想される)
2023年9月1日
試験登録日
最初に提出
2021年10月18日
QC基準を満たした最初の提出物
2021年11月23日
最初の投稿 (実際)
2021年12月7日
学習記録の更新
投稿された最後の更新 (実際)
2021年12月7日
QC基準を満たした最後の更新が送信されました
2021年11月23日
最終確認日
2021年10月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 2021 LAUTRETTE REPOPREGARDE
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?
いいえ
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米国FDA規制医薬品の研究
いいえ
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いいえ
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