Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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PROSPECTIVE
Study Groups
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Regular preanesthesia evaluation
Patients are evaluated by the anesthesiologist according to current protocol, including routine preoperative ECG.
No interventions assigned to this group
New preanesthesia evaluation
Patients are evaluated by the anesthesiologist according to a new protocol, in which a routine preoperative ECG is no longer provided.
Removal of preoperative electrocardiogram
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.
Interventions
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Removal of preoperative electrocardiogram
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.
Eligibility Criteria
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Inclusion Criteria
* 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 participation in long-term clinical and Quality of Life measurements
18 Years
ALL
No
Sponsors
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UMC Utrecht
OTHER
Responsible Party
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Wilton A van Klei
MD PhD
Principal Investigators
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Cor J Kalkman, MD PhD
Role: STUDY_CHAIR
UMC Utrecht
Wilton A van Klei, MD PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Jurgen C de Graaff, MD PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Locations
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University Medical Center Utrecht
Utrecht, , Netherlands
Countries
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References
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van Klei WA, Bryson GL, Yang H, Kalkman CJ, Wells GA, Beattie WS. The value of routine preoperative electrocardiography in predicting myocardial infarction after noncardiac surgery. Ann Surg. 2007 Aug;246(2):165-70. doi: 10.1097/01.sla.0000261737.62514.63.
Other Identifiers
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ECGtrial
Identifier Type: -
Identifier Source: org_study_id