Bypass PACU in Knee and Hip Arthroplasty

Surgery Clinical Trial

Official title:

Bypass Post-Anesthesia Care Unit(PACU) in Knee and Hip Arthroplasty - A Quality Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03984942
• Other study ID #: NBF_EKAa_01_2019
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: November 1, 2020

Study information

• Verified date: January 2021
• Source: Copenhagen University Hospital, Hvidovre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Planned elective unilateral primary Hip- og Knee-Arthroplasty and unicompartmental Knee-Arthroplasty.

• Above 18 years.

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Arthroplasty Complications
• Hip Osteoarthritis
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee
• Postoperative Complications
• Surgery

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital, Capital Region of Denmark.	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Niklas Ingemann Nielsen	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bypassing PACU	Number of patients in need of secondary relocation to the Post Anaesthesia Care unit after knee and hip arthroplasty.	Within the first 24 hours.
Secondary	Postoperative actions and interventions by nurses within 2 hours.	Postoperative interventions carried out within the first 2 hours after surgery. These interventions will be recorded in a preformed chart.; The recording will take place booth in the PACU and in the surgical ward, to thereby make a comparison of the two.	2 hours after surgery.
Secondary	Postoperative actions and interventions within 24 hours.	Postoperative interventions and deviant events/complications that require a contact to a medical doctor, either by telephone or personal oversight, carried out within the first 24 hours after surgery.; These interventions will be recorded in a preformed chart. This registration will take place where the patient is hospitalized at the current timeframe.	24 hours after surgery.
Secondary	30 day Follow-up.	30 day follow-up after surgery, concerning readmission within 8 days after surgery, length of stay and mortality.	30 days
Secondary	90 day Follow-up.	90 day follow-up after surgery concerning readmission and mortality.	90 days
Secondary	Complications after surgery.	Complications after surgery, divided in medical and surgical complications with details of type of event and time of occurence as well as treatment.	90 days