Clinical trial NCT03984942: Bypass PACU in Knee and Hip Arthroplasty
Official title: Bypass Post-Anesthesia Care Unit(PACU) in Knee and Hip Arthroplasty - A Quality Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Knee Osteoarthritis
Postoperative Complications
Hip Osteoarthritis
Arthroplasty Complications
Keywords: Knee Arthroplasty
Hip Arthroplasty
Postoperative Anaesthesia Care Unit
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2019-06-13
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Every patient planned for unilateral Primary Total Hip and Knee Arthroplasty and unilateral unicompartmental knee arthroplasty within a year, or until 600 patients is included.

Brief summary: A Quality Study in the use of Post-Anaesthesia Care Unit(PACU) in Hip and Knee Arthroplasty, and the ability to bypass this unit.

The investigators wish to investigate the amount of patients who is required to be secondary admitted to the PACU, after primary discharge from the operating room to the surgical ward, thereby bypassing the PACU.

Detailed description: The investigators wish to investigate the use of our standardized regimen for discharging patients directly to the surgical ward, thereby bypassing the PACU. The anaesthesiology dept. have a local standard operating procedure for doing this, and the patients will be treated according to this.

This means that Patients will be discharged directly to the surgical ward if the following criteria are met:

* American Society of Anaesthesiologist-score (ASA-score) \< 3
* Anaesthesia and surgery without any complications, vital signs normal during the whole procedure and not demanding oxygen supplement on the end of the procedure.
* Bloodloss \< 500 ml.
* Postoperative evaluation, Early Warning Score, and postoperative score documented in Electronic Patient journal(EPJ).

The patients will upon arrival at the surgery start a registration containing preoperative data(baseline morbidity, sex, height, weight, type of anaesthesia and surgery), perioperative data containing surgery and anaesthesia data, and postoperative discharge-score(local operating procedure).

After discharge to either the surgical ward or the PACU, the patient will be observed closely the first 2 hours while recording every intervention made by the nurse staff.

After the initial 2 hours the recording goes on the next 24 hours recording every event and intervention which lead to a doctor consult, by telephone or physically examining the patient.

Also, the investigators wish to evaluate the use of the discharge Score(Danish Society of Anaesthesia and Intensive care Medicine(DASAIM)-SCORE), which is used as the discharge score after surgery in other hospitals in Denmark, and the investigators therefore record this after surgery, and every 30 minutes after the surgery for the first 2 hours.

Eligibility criteria: Inclusion Criteria:

* Planned elective unilateral primary Hip- og Knee-Arthroplasty and unicompartmental Knee-Arthroplasty.
* Above 18 years.

Exclusion Criteria:

* none

Primary outcomes:
measure: Bypassing PACU
timeFrame: Within the first 24 hours.
Secondary outcomes:
measure: Postoperative actions and interventions by nurses within 2 hours.
timeFrame: 2 hours after surgery.
measure: Postoperative actions and interventions within 24 hours.
timeFrame: 24 hours after surgery.
measure: 30 day Follow-up.
timeFrame: 30 days
measure: 90 day Follow-up.
timeFrame: 90 days
measure: Complications after surgery.
timeFrame: 90 days
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital, Capital Region of Denmark.
Study officials:
affiliation: Centre for abdominal surgery, rigshospitalet.
name: Eske Aasvang, Dr.Med.
role: STUDY_DIRECTOR
References: