Observing early complications after surgery
The Incidence and Association of PACU Course and Early Postoperative Complications and Deterioration
This study looks at how changes in vital signs after surgery can help us understand complications in high-risk patients and improve their care before they leave the hospital.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Copenhagen University Hospital, Hvidovre Academic / other |
| Locations | 1 site (Hvidovre) |
| Trial ID | NCT06013891 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between vital sign deterioration and complications in the Post-Anesthesia Care Unit (PACU) and subsequent issues in surgical wards within 72 hours post-discharge. It focuses on high-risk surgical patients and aims to evaluate how early complications affect PACU length of stay, morbidity, mortality, and the need for rapid response team interventions. The study seeks to improve patient assessment and discharge readiness by examining the adequacy of current discharge scoring systems for fragile patients.
Who should consider this trial
Good fit: Ideal candidates include adult patients undergoing high-risk surgeries such as hip fractures, major abdominal surgeries, and lower limb amputations.
Not a fit: Patients undergoing low-risk surgeries or those with minimal expected complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance postoperative care and reduce complications for high-risk surgical patients.
How similar studies have performed: While there is limited evidence on this specific approach, the focus on early postoperative deterioration is gaining attention, suggesting potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hvidovre
- Amager and Hviovre Universitu Hospital — Hvidovre, Denmark (Recruiting)
Study contacts
- Principal investigator: Lea B Hvidberg, RN, Ms.c. — Dep. of Anesthesiology, Amager and Hvidovre University Hospital
- Study coordinator: Lea B Hvidberg, RN, Ms.c.
- Email: lea.baunegaard.hvidberg@regionh.dk
- Phone: 004560100020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.