Observational Study of Early Postoperative Deterioration and Complications

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06013891
• Other study ID #: F-22045028
• Status: Recruiting
• Start date: October 3, 2023
• Est. completion date: February 27, 2024

Study information

• Verified date: October 2023
• Source: Copenhagen University Hospital, Hvidovre
• Contact: Lea B Hvidberg, RN, Ms.c.
• Phone: 004560100020
• Email: lea.baunegaard.hvidberg[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: February 27, 2024
• Est. primary completion date: February 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesiology
• Clinical Deterioration
• Deterioration, Clinical
• Postoperative Care
• Postoperative Complications

Locations

Country	Name	City	State
Denmark	Amager and Hviovre Universitu Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital, Hvidovre

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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
Primary	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