Observational Study of Early Postoperative Deterioration and Complications

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Postoperative Care; Anesthesiology; Deterioration, Clinical

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Lea B Hvidberg, RN, Ms.c.; Phone Number: 004560100020; Email: lea.baunegaard.hvidberg@regionh.dk
• Study Contact Backup: Name: Nicolai B Foss, MD,Med.Sc.D; Phone Number: 38622532; Email: nicolai.bang.foss@regionh.dk

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Recruiting
    • Amager and Hviovre Universitu Hospital
    • Contact: Lea Hvidberg, MSc. phd student; Phone Number: 005660100020; Email: lea.baunegaard.hvidberg@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The association between deterioration, complications, and PACU length of stay	How are deterioration and/or complications associated with prolonged PACU stay PACU length of stay? (> 2 hours)	Up to 24 hours
The association between individual PACU discharge score and early risk of deterioration and complications within 72 hours post-PACU discharge	Can the discharge score (modified Aldrete score/aggregated score of vital signs) be a predictive value (of high individual or high total score) for early risk of deterioration and complications	Up tp 72 hours
The percentages of RRT call-outs (Early warning score >7) within 72 hours post-PACU discharge	How many patients will experience an Early Warning Score >7 (Early warning score is an aggregated score of physiological parameter). At a high score of equal to or above 7, the RRT should be contacted)	Up to 72 hours post PACU discharge
The percentages of extra medical, surgical, or ICU supervision within 72 hours post-PACU discharge	How many patients will experience extra medical, surgical, or ICU supervision within 72 hours	Up to 72 hours post PACU discharge
The percentages of unexpected patient transfer to cardiology, the pulmonary department, or the ICU	How many patients will experience unexpected transfer to cardiology, the pulmonary department, or the ICU	Up to four days from PACU admittance
PACU nurse prediction (triage categories) of the patient course within 72 hours post-PACU discharge	The triage categories are; green) stable and uncomplicated postoperative course. Yellow) Potentially unstable with a risk of minor risk of a complicated postoperative course. Orange) Unstable, at high risk of a complicated postoperative course. Red) in a critical condition with the risk off life-threatening complications	At PACU discharge to surgical ward (up to 24 hours from PACU admittance)
Surgical ward nurse prediction (triage categories) of the patient course within 72 hours post-PACU discharge	What are the receiving ward nurse's clinical predictions of the patient course within 72 hours post-PACU discharge. The triage categories are; green) stable and uncomplicated postoperative course. Yellow) Potentially unstable with a risk of minor risk of a complicated postoperative course. Orange) Unstable, at high risk of a complicated postoperative course. Red) in a critical condition with the risk of life-threatening complications	When the ward nurse receive the patient from the PACU (up to 24 hours of PACU admittance)
The association between the triage categories and deterioration and complications within 72 hours post-PACU discharge	Can PACU and ward nurses predict the outcome of the patient course within the first 72 hours post PACU discharge (within the defined triage categories describing the conditions)	Up to 72 hours post PACU discharge or at hospital discharge (under 72 hours from PACU discharge)
Agreement between the PACU nurse' and ward nurses' triage	How aligned are the PACU and ward nurses' predictions within the first 72 hours post-PACU discharge or at hospital discharge? Alignment will be explored using kappa statistics	Up to 72 hours post PACU discharge or at hospital discharge (under 72 hours from PACU discharge)

Collaborators and Investigators

• Sponsor: Copenhagen University Hospital, Hvidovre
• Investigators: Principal Investigator: Lea B Hvidberg, RN, Ms.c., Dep. of Anesthesiology, Amager and Hvidovre University Hospital; Study Chair: 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 record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Estimated): February 27, 2024
• Study Completion (Estimated): February 27, 2024

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Postoperative Complications; Postoperative Care; Clinical assessment; Deterioration, Clinical
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression; Postoperative Complications; Clinical Deterioration
• Other Study ID Numbers: F-22045028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Time Frame: Data will be available starting 6 months after publication
• IPD Sharing Access Criteria: Data can by shared by request to the principal researcher
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No