Observational Study of Early Postoperative Deterioration and Complications

NCT ID: NCT06013891

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-03
• Study Completion Date: 2024-04-03

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 wards 72 hours post-PACU discharge.

The participants studied will be high-risk surgical patients who will follow a normal postoperative course from the PACU to the surgical ward. The investigators seek to evaluate the association between deterioration and complications within the PACU with vital signs deterioration and complications in the surgical wards. Second, the investigators will explore how deterioration and complications affect PACU length of stay, morbidity, mortality, rapid response Teams call-outs (RRT) (Early warning score >7), extra medical patient supervision, and unplanned intensive care unit (ICU) admissions. The investigators will also examine the nurses' assessment of the patient's risk of deterioration and complications upon discharge from the PACU and admission to the surgical department.

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 postoperative complications and 30-day mortality, little attention has been paid to the PACU as a point of in-patient triage for early postoperative deterioration and complications. PACU to surgical ward discharge readiness is often based on a quantitative discharge score that does not account for the patient's physiological responses or distinguish between surgery type, age, and co-morbidities.

The discharge score is a clinical decision-making tool that sets the frame for the patient's readiness for discharge and functions as a "one six fits all" system. However, this "one size fits all" approach may not be adequate as a discharge tool when discharging high-risk, fragile patients from the PACU. The current evidence on using criterion-based discharge scores and the connection with early postoperative deterioration and complications are absent and need further investigation.

It is unclear whether early postoperative deterioration and complications can be predicted and assessed during PACU stay. Thus leaving a big potential for improvement in patient assessment and detection of early deterioration and complications, improving safe PACU discharge for high-risk fragile patients. Providing new knowledge on early postoperative deterioration and complications within high-risk, fragile patient groups could improve postoperative courses and patient safety.

Statistical analysis plan Data is expected to be divided into two (or 3) consecutive studies.

Conditions

Postoperative Complications; Deterioration, Clinical; Postoperative Care; Anesthesiology

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Copenhagen University Hospital, Hvidovre

OTHER

Sponsor Role: lead

Responsible Party

Lea Baunegaard Hvidberg

Clinical Nurse Specialist, Ph.d-fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lea B Hvidberg, RN, Ms.c.

Role: PRINCIPAL_INVESTIGATOR

Dep. of Anesthesiology, Amager and Hvidovre University Hospital

Eske K Aasvang, MD,Med.Sc.D.

Role: STUDY_CHAIR

Centre for Cancer and Organ Diseases, Rigshospitalet, University Hospital

Martin G Tolsgaard, MD,Med.Sc.D.

Role: STUDY_CHAIR

CAMES Rigshospitalet and Department of Obstetrics, Rigshospitalet, University Hospital

Nicolai B Foss, MD,Med.Sc.D.

Role: STUDY_CHAIR

Department of Anesthesiology, Amager and Hvidovre University Hospital

Locations

Amager and Hviovre Universitu Hospital

Hvidovre, , Denmark

Countries

Denmark

Other Identifiers

F-22045028

Identifier Type: -

Identifier Source: org_study_id