Identifying Patients in Risk of Post-operative Complications Using PACU Discharge Criteria
- Conditions
- Complication,PostoperativePost-Op Complication
- Registration Number
- NCT04188093
- Lead Sponsor
- Rigshospitalet, Denmark
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Elective surgery
- Pancreaticoduodenectomy (KJLC30)
- Transthoracic esophageal resection without interposition (KJCC10)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical in-hospital complications until discharge, up to 90 days Occurence of clinical complications occuring during the hospital stay (pneumonia, myocardial infarction, brain stroke, renal impairment, etc), based upon international definitions
- Secondary Outcome Measures
Name Time Method bradypnea During the first 4 postoperative days respiratory rate \<8/min for 30 minutes, measured by ECG
Severe hypotension During the first 4 postoperative days Middle arterial blood pressure \<65 for \>29 minutes measured by non-invasive manometer
Hypotension During the first 4 postoperative days Middle arterial blood pressure \<75 for \>29 minutes measured by non-invasive manometer
Very severe desaturation During the first 4 postoperative days Arterial saturation \<80% lasting \>10 minutes per episode, measured by pulse oximeter
Tachypnea During the first 4 postoperative days respiratory rate \>20/min for 30 minutes, measured by ECG
Severe tachypnea During the first 4 postoperative days respiratory rate \>30/min for 30 minutes, measured by ECG
Severe desaturation During the first 4 postoperative days Arterial saturation \<85% lasting \>10 minutes per episode, measured by pulse oximeter
Clinical out of hospital complications until 96 days postoperatively Occurence of clinical complications occuring after the hospital stay (pneumonia, myocardial infarction, brain stroke, renal impairment, etc), based upon international definitions
Bradycardia During the first 4 postoperative days pulse \<40/min measured by pulse oximeter
Tachycardia During the first 4 postoperative days pulse \>140/min meausured by pulseoximetry
Trial Locations
- Locations (1)
Rigshospitalet
🇩🇰Copenhagen, Denmark