Efficacy of Preoperative Electrocardiography
The Efficacy of Routine Preoperative Electrocardiography in Patients Undergoing Non-cardiac Surgery
調査の概要
詳細な説明
Objective:
A routine ECG is performed as part of the standard diagnostic workup before non-cardiac surgery. However, the added value of this test beyond patient history and physical examination is questionable. The proposed study therefore aims to determine whether preoperative assessment without ECG is more cost-effective.
Study design:
Prospective stepped wedge design multicenter trial including 40,000 patients.
Study population:
All patients aged over 60 years, or younger patients with cardiovascular risk factors, scheduled for non-cardiac surgery with an expected postoperative hospital stay of at least 2 days.
Intervention:
A new preoperative assessment strategy without routine ECG. Initially, all patients in the participating centers are assessed following the regular strategy (with routine ECG). The new strategy (without routine ECG) is rolled out to the participating hospitals sequentially. At the end of the trial all participating centers will use the new preoperative strategy.
Outcome measures:
The primary outcome measure is cardiac death or perioperative myocardial infarction. The latter will be verified by Troponin values at postoperative day 1 and 2. If the Troponin levels are elevated the presence of myocardial infarction will be evaluated by a consulting cardiologist. Secondary outcomes are other major cardiovascular complications, death from other causes within 2 days of surgery, and long term quality of life. To determine cost-effectiveness of the strategy without ECG all pre- and postoperative referrals and interventions are taken into account.
Sample size calculation:
We expect no increase in the primary outcome in the intervention group. To rule out an 0.5% increase (from 3% to 3.5%) in the intervention group, the inclusion of 36,504 patients is required (level of confidence: 0.95; power: 0.80). To compensate for expected 10% loss-to-follow up, 40,000 patients will be randomized.
Economic evaluation:
A cost-effectiveness analysis will be conducted when the increase in primary outcome is between 0.0 and 0.5%. If the intervention results in a lower prevalence of the primary outcome, no cost-effectiveness analysis is performed as the health and cost outcomes point in the same, advantageous, direction. An increase of more than 0.5% is not considered acceptable from a clinical point of view.
研究の種類
連絡先と場所
研究場所
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Utrecht、オランダ、3508 GA
- University Medical Center Utrecht
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- All patients aged 60 years or older scheduled for noncardiac surgery with an expected hospital length of stay of at least 2 days
- Patients aged under 60 years but with risk factors for cardiovascular disease scheduled for noncardiac surgery with an expected hospital length of stay of at least 2 days
Exclusion Criteria:
- Patients refusing informed consent for obtaining blood samples (troponin measurement) at the first two days after surgery
- Patients refusing participation in long-term clinical and Quality of Life measurements
研究計画
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 |
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Regular preanesthesia evaluation
Patients are evaluated by the anesthesiologist according to current protocol, including routine preoperative ECG.
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New preanesthesia evaluation
Patients are evaluated by the anesthesiologist according to a new protocol, in which a routine preoperative ECG is no longer provided.
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A new preanesthesia evaluation strategy without routine ECG.
Initially, all patients in the participating centers are assessed following the regular strategy (with routine ECG).
The new strategy (without routine ECG) is rolled out to the participating hospitals sequentially.
At the end of the trial all participating centers will use the new preoperative strategy.
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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 |
時間枠 |
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Cardiac death or perioperative myocardial infarction
時間枠:2 days postoperatively
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2 days postoperatively
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二次結果の測定
結果測定 |
時間枠 |
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Other major cardiovascular complications
時間枠:2 days postoperatively
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2 days postoperatively
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Death from other causes
時間枠:2 days postoperatively
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2 days postoperatively
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Long term quality of life
時間枠:One year
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One year
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協力者と研究者
スポンサー
捜査官
- スタディチェア:Cor J Kalkman, MD PhD、UMC Utrecht
- 主任研究者:Wilton A van Klei, MD PhD、UMC Utrecht
- 主任研究者:Jurgen C de Graaff, MD PhD、UMC Utrecht
出版物と役立つリンク
研究記録日
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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