Wireless Assessment of Respiratory and Circulatory Distress; A Pilot Study

Study Overview
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Brief Summary
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Postoperative observation of patients is based on the Early Warning Score (EWS). By using continuous wireless monitoring of vital parameters it may be possible to predict the risk of complications after abdominal cancer surgery. The object of this pilot study is to test the equipment and methods for the next phases. Patients will be monitored for 4 days postoperatively and data is analyzed retrospectively. Vital parameters are monitored with ECG, blood pressure monitor and pulseoximetry. In the analysis the investigators will compare the results from the continuous monitoring to the measurements made by the nurses and registered in the EWS. The primary outcomes for the pilot study are the frequency of measurements resulting in a single parameter score of 3 according to the EWS algorithm.

Official Title
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Wireless Assessment of Respiratory and Circulatory Distress; A Pilot Study

Conditions
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Abdominal Cancer, Postoperative Complications, Respiratory Complication, Circulatory; Complications

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cancer of either esophagus, stomach, pancreas, liver, colon or rectum. Elective surgery with curative intention at Bispebjerg Hospital or Rigshospitalet in Copenhagen, Denmark. Estimated duration of surgery > 2 hours > 65 years Preoperative ECG showing sinus rhythm No treatment limitations Fit to receive optimized care according to the regimens on the given wards

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate resulting in a single parameter score of 3 according to EWS algorithm | All data from the monitoring will be analyzed using the thresholds from the EWS algorithm and will be sorted into relevant categories. The following thresholds are used: Bradycardia: pulse < 41 bpm Tachycardia: pulse > 130 bpm | The patients are monitored for 4 days | 
| Respiration rate resulting in a single parameter score of 3 according to EWS algorithm | Bradypnea: < 9 breaths/min Tachypnea: > 24 breaths/min | The patients are monitored for 4 days | 
| Blood pressure resulting in a single parameter score of 3 according to EWS algorithm | Hypotension: Systolic blood pressure < 91 mmHg Hypertension: Systolic blood pressure > 219 mmHg | The patients are monitored for 4 days | 
| Blood oxygen saturation resulting in a single parameter score of 3 according to EWS algorithm | Hypoxemia: arterial oxygen saturation < 92 % | The patients are monitored for 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wireless monitoring, Postoperative complications, Vital parameters, Continuous monitoring