Status:

UNKNOWN

Observational Study of Early Postoperative Deterioration and Complications

Lead Sponsor:

Copenhagen University Hospital, Hvidovre

Conditions:

Postoperative Complications

Deterioration, Clinical

Eligibility:

All Genders

18+ years

Brief Summary

This prospective observational research project aims to investigate how vital sign deterioration and complications within the (PACU) relate to early deterioration and complications in the surgical war...

Detailed Description

Postoperative complications are increasing and are an under-recognized cause of morbidity and mortality. While there has been significant attention to preoperative risk assessments for late postoperat...

Eligibility Criteria

Inclusion

  • Patients who wish to participate will sign a consent form. Baseline data will be obtained on all eligible participants; however, the full registry will only be obtained for those who permit us.
  • To recruit participants, the surgical schedules will be screened on a daily basis by the principal investigator and/or a member of the research team (VB).
  • Data entry has been prepared in RedCap, a secure method of robust data collection. All data entry will be reviewed and validated by LBH and VB. In case of discrepancies or inconsistencies, senior members of the research team NBF or EKA will review data for clarity and validation.
  • Adult patients undergoing surgery for a hip fracture, lower limb amputation, open liver resection, open pancreatic, and esophageal/gastric surgery
  • And
  • Adult patients undergoing open or laparoscopic major abdominal surgery and orthopedic surgery
  • Surgery time over 2 hours
  • American Society of Anesthesiologists (ASA) physical status classification system 3 - 4

Exclusion

  • Pre-planned fixed minimum PACU stay
  • Planned intensive care unit (ICU) stay
  • Terminally ill
  • Incapable of giving informed consent

Key Trial Info

Start Date :

October 3 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

February 27 2024

Estimated Enrollment :

250 Patients enrolled

Trial Details

Trial ID

NCT06013891

Start Date

October 3 2023

End Date

February 27 2024

Last Update

October 5 2023

Active Locations (1)

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1

Amager and Hviovre Universitu Hospital

Hvidovre, Denmark, 2650