Identifying Patients in Risk of Post-operative Complications Using PACU Discharge Criteria
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
November 26, 2019
CompletedFirst Posted
Study publicly available on registry
December 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedJanuary 11, 2022
December 1, 2021
3.1 years
November 26, 2019
December 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Bradycardia
During the first 4 postoperative days
Tachycardia
During the first 4 postoperative days
Severe desaturation
During the first 4 postoperative days
Very severe desaturation
During the first 4 postoperative days
Hypotension
During the first 4 postoperative days
- +5 more secondary outcomes
Other Outcomes (1)
description of other physiological deviations
during hospital stay, up to 30 days
Interventions
* PACU discharge criteria (modified aldrete score). * Continous monitoring of vital signs 96 postoperative hours
Eligibility Criteria
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
You may qualify if:
- Elective surgery
- Pancreaticoduodenectomy (KJLC30)
- Transthoracic esophageal resection without interposition (KJCC10)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rigshospitalet
Copenhagen, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Eske K Aasvang, Dr. Med.
Rigshospitalet, Denmark
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of research, Clinical professor, Principal Investigator
Study Record Dates
First Submitted
November 26, 2019
First Posted
December 5, 2019
Study Start
January 1, 2018
Primary Completion
January 20, 2021
Study Completion
June 1, 2021
Last Updated
January 11, 2022
Record last verified: 2021-12