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

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.

Study Overview

• Status: Completed
• Conditions: Complication,Postoperative; Post-Op Complication
• Intervention / Treatment: Other: PACU discharge criteria and continuous monitoring 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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients over 60 years under surgery for abdominal cancer.

• Pancreaticoduodenectomy (KJLC30)
• transthoracic esophageal resection without interposition (KJCC10)

Patients undergoing described surgery stay at least 24 hours in PACU following local guidelines

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
description of other physiological deviations	description og frequency and duration of other physiological deviations (fever, arrythmia, apnea, arrythmia, etc)	during hospital stay, up to 30 days

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Study Chair: Eske K Aasvang, Dr. Med., Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): January 20, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: PACU; Postoperative Care Unit; Continous monitoring; PACU discharge criteria
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: PIRCPAC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No