Observational Study of Early Postoperative Deterioration and Complications

Launched by COPENHAGEN UNIVERSITY HOSPITAL, HVIDOVRE · Aug 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how changes in patients' vital signs and complications during their time in the Post-Anesthesia Care Unit (PACU) can affect their recovery in the surgical ward within the first 72 hours after surgery. The focus is on high-risk surgical patients who have undergone major surgeries, like hip fractures or major abdominal operations. Researchers want to understand if early issues in the PACU lead to further problems on the surgical ward, as well as how these issues might influence the length of stay in the PACU or the need for extra medical support.

To participate in this study, patients must be adults undergoing specific types of major surgery, with some health risks. They will need to give their consent to be involved. Participants can expect to be monitored closely during and after their surgery, and their vital signs and overall condition will be tracked to see how they recover. It’s important to note that patients who are terminally ill or unable to provide informed consent will not be included in the trial. This research aims to improve postoperative care and patient outcomes by better understanding the relationship between early complications and recovery.

Gender

ALL

Eligibility criteria

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