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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04188093
Enrollment
100
Registered
2019-12-05
Start date
2018-01-01
Completion date
2021-06-01
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication,Postoperative, Post-Op Complication

Keywords

PACU, Postoperative Care Unit, Continous monitoring, PACU discharge criteria

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.

Interventions

OTHERPACU discharge criteria and continuous monitoring on the ward

* PACU discharge criteria (modified aldrete score). * Continous monitoring of vital signs 96 postoperative hours

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to 110 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical in-hospital complicationsuntil discharge, up to 90 daysOccurence of clinical complications occuring during the hospital stay (pneumonia, myocardial infarction, brain stroke, renal impairment, etc), based upon international definitions

Secondary

MeasureTime frameDescription
BradycardiaDuring the first 4 postoperative dayspulse \<40/min measured by pulse oximeter
TachycardiaDuring the first 4 postoperative dayspulse \>140/min meausured by pulseoximetry
Severe desaturationDuring the first 4 postoperative daysArterial saturation \<85% lasting \>10 minutes per episode, measured by pulse oximeter
Very severe desaturationDuring the first 4 postoperative daysArterial saturation \<80% lasting \>10 minutes per episode, measured by pulse oximeter
HypotensionDuring the first 4 postoperative daysMiddle arterial blood pressure \<75 for \>29 minutes measured by non-invasive manometer
bradypneaDuring the first 4 postoperative daysrespiratory rate \<8/min for 30 minutes, measured by ECG
TachypneaDuring the first 4 postoperative daysrespiratory rate \>20/min for 30 minutes, measured by ECG
Severe tachypneaDuring the first 4 postoperative daysrespiratory rate \>30/min for 30 minutes, measured by ECG
Clinical out of hospital complicationsuntil 96 days postoperativelyOccurence of clinical complications occuring after the hospital stay (pneumonia, myocardial infarction, brain stroke, renal impairment, etc), based upon international definitions
Severe hypotensionDuring the first 4 postoperative daysMiddle arterial blood pressure \<65 for \>29 minutes measured by non-invasive manometer

Other

MeasureTime frameDescription
description of other physiological deviationsduring hospital stay, up to 30 daysdescription og frequency and duration of other physiological deviations (fever, arrythmia, apnea, arrythmia, etc)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026