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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
| Technical University of Denmark | OTHER |
| Danish Cancer Society | OTHER |
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A high percentage of patients undergoing major abdominal surgery will develop a postoperative complication. Our hypothesis is that by observing postoperative patients with continuous wireless monitoring, it is possible to detect the correlation between deviating vital parameters and subsequent postoperative complications. A prospective observational study will take place on general surgical wards with the enrolment of 500 patients in two different hospitals. Physiological parameters will be recorded for 96 hours postoperative. Data is collected preoperative, peroperative and postoperative in up to 6 months for data analyzing.
An estimated > 230 million cases of major surgery are performed worldwide annually. Surgical interventions come with an inherent risk of complications. 15 - 30 % of all patients undergoing major abdominal surgery will develop a severe complication post-operative. These numbers correspond to the reported high postoperative in-hospital mortality, 8-9% after major upper abdominal surgery, increased in case of co-morbidities. Part of the high morbidity and mortality may be a result of delayed detection of severe complications due to the lower monitoring frequency in the general wards compared to the Post Anaesthesia Care Unit (PACU) and Intensive Care Unit (ICU). Improved observation may result in earlier detection and subsequently the possibility to implement interventions to divert a negative trajectory and ultimately reduce morbidity and mortality.
This study wish to investigate the correlation between deviating physiological parameters and postoperative complications.
In a prospective observational study, 500 patients enrolled for major abdominal cancer surgery at Rigshospitalet or Bispebjerg Hospital will be included after a signed declaration of consent.
Demographic data will be recorded together with preoperative spirometry, timed-up-and-go, Mini Mental State Examination and an electrocardiogram.
Post-operative when leaving the PACU, a wireless continuous monitoring system will be attached to the patients. The monitoring system will be recording the vital parameters 24/7.
In parallel to the wireless monitoring, the patients will receive normal treatment and monitoring (Early Warning Score) from staff on the wards. Patients are monitored for 96 hours or until they are dismissed from hospital.
Furthermore blood samples will be collected once every day for 96 hours and the patients are appointed daily by an investigator.
Exposure variables is deviation of vital parameters from normal range, socalled microevents.
Descriptive statistic will be used in analyzing the data.
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| Measure | Description | Time Frame |
|---|---|---|
| Any serious adverse event | e.g cardiac arrest, ICU admission, acute myocardial infarction, sepsis, stroke, acute kidney injury, pneumonia or other serious adverse events (defined in Protocol Appendix A) | within 30 days after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 6 months postoperative | |
| Readmission | Acute readmission to hospital. | 6 months postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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Patients enrolled for elective abdominal cancer surgery at Bispebjerg Hospital or Rigshospitalet will be invited to be a part of this study if they meet the inclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Camilla Haahr-Raunkjær, MD | Surgical department, Bispebjerg Hospital | Principal Investigator |
| Eske K Aasvang, Dr.med. | Abdominal surgical department, Rigshospitalet | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abdominal surgical department, Rigshospitalet | Copenhagen | 2200 | Denmark | |||
| Surgical department, Bispebjerg Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35213523 | Derived | Jokinen JDV, Carlsson CJ, Rasmussen SM, Nielsen OW, Winkel BG, Jorgensen LN, Achiam MP, Molgaard J, Sorensen HBD, Aasvang EK, Meyhoff CS; WARD Project Group. Wireless Single-Lead ECG Monitoring to Detect New-Onset Postoperative Atrial Fibrillation in Patients After Major Noncardiac Surgery: A Prospective Observational Study. Anesth Analg. 2022 Jul 1;135(1):100-109. doi: 10.1213/ANE.0000000000005960. Epub 2022 Feb 25. | |
| 35170026 |
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No plan of sharing IPD to other researchers
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Copenhagen |
| 2400 |
| Denmark |
| Derived |
| Haahr-Raunkjaer C, Molgaard J, Elvekjaer M, Rasmussen SM, Achiam MP, Jorgensen LN, Sogaard MIV, Gronbaek KK, Oxboll AB, Sorensen HBD, Meyhoff CS, Aasvang EK. Continuous monitoring of vital sign abnormalities; association to clinical complications in 500 postoperative patients. Acta Anaesthesiol Scand. 2022 May;66(5):552-562. doi: 10.1111/aas.14048. Epub 2022 Feb 28. |