Efficacy of Preoperative Electrocardiography
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00928460|
Recruitment Status : Withdrawn
First Posted : June 26, 2009
Last Update Posted : July 31, 2013
|Condition or disease||Intervention/treatment|
|Acute Coronary Syndrome Myocardial Infarction Cardiac Arrest||Procedure: Removal of preoperative electrocardiogram|
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.
Prospective stepped wedge design multicenter trial including 40,000 patients.
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.
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.
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.
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.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||The Efficacy of Routine Preoperative Electrocardiography in Patients Undergoing Non-cardiac Surgery|
Regular preanesthesia evaluation
Patients are evaluated by the anesthesiologist according to current protocol, including routine preoperative ECG.
New preanesthesia evaluation
Patients are evaluated by the anesthesiologist according to a new protocol, in which a routine preoperative ECG is no longer provided.
Procedure: 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.
- Cardiac death or perioperative myocardial infarction [ Time Frame: 2 days postoperatively ]
- Other major cardiovascular complications [ Time Frame: 2 days postoperatively ]
- Death from other causes [ Time Frame: 2 days postoperatively ]
- Long term quality of life [ Time Frame: One year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00928460
|University Medical Center Utrecht|
|Utrecht, Netherlands, 3508 GA|
|Study Chair:||Cor J Kalkman, MD PhD||UMC Utrecht|
|Principal Investigator:||Wilton A van Klei, MD PhD||UMC Utrecht|
|Principal Investigator:||Jurgen C de Graaff, MD PhD||UMC Utrecht|