Observational Study of Early Postoperative Deterioration and Complications

NCT06013891 | Completed DMC

• 1 other identifier: F-22045028
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications; Deterioration, Clinical; Postoperative Care; Anesthesiology

Keywords

Postoperative Complications; Deterioration, Clinical; Postoperative Care; Clinical assessment

Outcome Measures

Primary Outcomes (2)

• The incidence of deterioration and complications during the first 72 hours post-PACU discharge and its association with deterioration and complication rates in the PACU

  In accordance with ICH-GCP: any untoward medical occurrence that(...) * Results in death * Is life-threatening * Requires inpatient hospitalization or causes prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Requires intervention to prevent permanent impairment or damage And/or severe deviating vital signs defined as outside normal thresholds.

  Up to three days

• The incidence of deterioration and complications during PACU stay

  In accordance with ICH-GCP: any untoward medical occurrence that(...) * Results in death * Is life-threatening * Requires inpatient hospitalization or causes prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Requires intervention to prevent permanent impairment or damage And/or severe deviating vital signs defined as outside normal thresholds.

  Up to four our days

Other Outcomes (9)

• The association between deterioration, complications, and PACU length of stay

  Up to 24 hours

• The association between individual PACU discharge score and early risk of deterioration and complications within 72 hours post-PACU discharge

  Up tp 72 hours

• The percentages of RRT call-outs (Early warning score >7) within 72 hours post-PACU discharge

  Up to 72 hours post PACU discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We will include approximately 250 adults undergoing surgery for hip fracture, lower limb amputation, open liver resection, open pancreatic and esophageal/gastric surgery, and open or laparoscopic major abdominal surgery. The surgical patient categories are selected based on types of surgery performed at the research sites, clinical experience, and well-known high risks of postoperative morbidity and mortality.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead

Study Sites (1)

Amager and Hviovre Universitu Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (1)

• Hvidberg LB, Aasvang EK, Bak E, Bank V, Poulsen LR, Tolsgaard MG, Foss NB. Beyond discharge score: postoperative care unit nurses' clinical assessments improve postoperative risk stratification: A prospective cohort study. Eur J Anaesthesiol. 2026 Mar 10. doi: 10.1097/EJA.0000000000002362. Online ahead of print.

  PMID: 41804675 DERIVED

MeSH Terms

Conditions

Postoperative Complications; Clinical Deterioration

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Progression; Disease Attributes

Study Officials

• Lea B Hvidberg, RN, Ms.c.

  Dep. of Anesthesiology, Amager and Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

• Eske K Aasvang, MD,Med.Sc.D.

  Centre for Cancer and Organ Diseases, Rigshospitalet, University Hospital

  STUDY CHAIR

• Martin G Tolsgaard, MD,Med.Sc.D.

  CAMES Rigshospitalet and Department of Obstetrics, Rigshospitalet, University Hospital

  STUDY CHAIR

• Nicolai B Foss, MD,Med.Sc.D.

  Department of Anesthesiology, Amager and Hvidovre University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Nurse Specialist, Ph.d-fellow

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: August 28, 2023
• Study Start: October 3, 2023
• Primary Completion: April 3, 2024
• Study Completion: April 3, 2024
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available starting 6 months after publication
• Access Criteria: Data can by shared by request to the principal researcher

Locations

DK (1)