Clinical trial NCT06013891: Observational Study of Early Postoperative Deterioration and Complications
Official title: The Incidence and Association of PACU Course and Early Postoperative Complications and Deterioration
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Complications
Deterioration, Clinical
Postoperative Care
Anesthesiology
Keywords: Postoperative Complications
Deterioration, Clinical
Postoperative Care
Clinical assessment
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: The incidence of deterioration and complications during PACU stay
timeFrame: Up to four our days
measure: 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
timeFrame: Up to three days
Secondary outcomes:
Other outcomes:
measure: The association between deterioration, complications, and PACU length of stay
timeFrame: Up to 24 hours
measure: The association between individual PACU discharge score and early risk of deterioration and complications within 72 hours post-PACU discharge
timeFrame: Up tp 72 hours
measure: The percentages of RRT call-outs (Early warning score >7) within 72 hours post-PACU discharge
timeFrame: Up to 72 hours post PACU discharge
measure: The percentages of extra medical, surgical, or ICU supervision within 72 hours post-PACU discharge
timeFrame: Up to 72 hours post PACU discharge
measure: The percentages of unexpected patient transfer to cardiology, the pulmonary department, or the ICU
timeFrame: Up to four days from PACU admittance
measure: PACU nurse prediction (triage categories) of the patient course within 72 hours post-PACU discharge
timeFrame: At PACU discharge to surgical ward (up to 24 hours from PACU admittance)
measure: Surgical ward nurse prediction (triage categories) of the patient course within 72 hours post-PACU discharge
timeFrame: When the ward nurse receive the patient from the PACU (up to 24 hours of PACU admittance)
measure: The association between the triage categories and deterioration and complications within 72 hours post-PACU discharge
timeFrame: Up to 72 hours post PACU discharge or at hospital discharge (under 72 hours from PACU discharge)
measure: Agreement between the PACU nurse' and ward nurses' triage
timeFrame: Up to 72 hours post PACU discharge or at hospital discharge (under 72 hours from PACU discharge)
Locations:
city: Hvidovre
country: Denmark
facility: Amager and Hviovre Universitu Hospital
Study officials:
affiliation: Dep. of Anesthesiology, Amager and Hvidovre University Hospital
name: Lea B Hvidberg, RN, Ms.c.
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Cancer and Organ Diseases, Rigshospitalet, University Hospital
name: Eske K Aasvang, MD,Med.Sc.D.
role: STUDY_CHAIR
affiliation: CAMES Rigshospitalet and Department of Obstetrics, Rigshospitalet, University Hospital
name: Martin G Tolsgaard, MD,Med.Sc.D.
role: STUDY_CHAIR
affiliation: Department of Anesthesiology, Amager and Hvidovre University Hospital
name: Nicolai B Foss, MD,Med.Sc.D.
role: STUDY_CHAIR
References: