Observational Study of Early Postoperative Deterioration and Complications

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Incidence and Association of PACU Course and Early Postoperative Complications and Deterioration

Conditions
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Postoperative Complications, Deterioration, Clinical, Postoperative Care, Anesthesiology

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Complications, Deterioration, Clinical, Postoperative Care, Clinical assessment