Identifying Patients in Risk of Post-operative Complications Using PACU Discharge Criteria

Study Overview
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Brief Summary
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In the Postoperative Care Unit surgical patients are monitored closely to ensure safe condition before transfer to the ward. This study will aim to identify patients in risk of complications on the ward using the national postanesthesia care unit (PACU) discharge criteria, a modified Aldretes score. Secondary to identify patients in risk of micro events as detected by continuous monitoring of vital signs on the ward.

Detailed Description
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Patients undergoing esophageal resection and pancreaticoduodenectomy are at high risk of developing complications after surgery. Described patient groups are monitored for at least 24 hours in PACU before returning to the ward. In Denmark physiological parameters are assessed in the PACU every hour until discharge using the DASAIM discharge criteria (A modified Aldrete score). The PACU discharge score is calculated on parameters including sedation, respiratory rate, saturation, systolic blood pressure, puls, physical capability (if epidural or spinal anesthesia), pain in rest, nausea, diuresis and temperature. Each parameter is given a score between 0 and 3. 0 describes no problem and 3 describes a severe problem. The investigators will investigate the predictive value of the PACU discharge criteria and interventions in the PACU setting, to identify patients at risk of developing postoperative complications. Secondary outcome is micro events on the ward. Patients vital signs are monitored continuously from PACU discharge until the 5th postoperative day. Micro events are defined as deviations of vital parameters from normal range.

Official Title
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Identifying Patients in Risk of Post-operative Complications Using PACU Discharge Criteria and Need for Interventions in the PACU Setting

Conditions
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Complication,Postoperative, Post-Op Complication

Intervention / Treatment
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* Other: PACU discharge criteria and continuous monitoring on the ward


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective surgery Pancreaticoduodenectomy (KJLC30) Transthoracic esophageal resection without interposition (KJCC10) Exclusion Criteria: Patients not expected to be able to cooperate Patients not cognitive well (Mini Mental State Examination < 24) Pacemaker Patients with allergies including band aid, plastic and silicone

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: PACU discharge criteria and continuous monitoring on the ward|PACU discharge criteria (modified aldrete score). Continous monitoring of vital signs 96 postoperative hours|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical in-hospital complications | Occurence of clinical complications occuring during the hospital stay (pneumonia, myocardial infarction, brain stroke, renal impairment, etc), based upon international definitions | until discharge, up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bradycardia | pulse <40/min measured by pulse oximeter | During the first 4 postoperative days | 
| Tachycardia | pulse >140/min meausured by pulseoximetry | During the first 4 postoperative days | 
| Severe desaturation | Arterial saturation <85% lasting >10 minutes per episode, measured by pulse oximeter | During the first 4 postoperative days | 
| Very severe desaturation | Arterial saturation <80% lasting >10 minutes per episode, measured by pulse oximeter | During the first 4 postoperative days | 
| Hypotension | Middle arterial blood pressure <75 for >29 minutes measured by non-invasive manometer | During the first 4 postoperative days | 
| Severe hypotension | Middle arterial blood pressure <65 for >29 minutes measured by non-invasive manometer | During the first 4 postoperative days | 
| bradypnea | respiratory rate <8/min for 30 minutes, measured by ECG | During the first 4 postoperative days | 
| Tachypnea | respiratory rate >20/min for 30 minutes, measured by ECG | During the first 4 postoperative days | 
| Severe tachypnea | respiratory rate >30/min for 30 minutes, measured by ECG | During the first 4 postoperative days | 
| Clinical out of hospital complications | Occurence of clinical complications occuring after the hospital stay (pneumonia, myocardial infarction, brain stroke, renal impairment, etc), based upon international definitions | until 96 days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PACU, Postoperative Care Unit, Continous monitoring, PACU discharge criteria