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CompletedNCT03984942Updated Feb 2, 2021

Bypass PACU in Knee and Hip Arthroplasty

An observational study in Surgery, Knee Osteoarthritis and Postoperative Complications, sponsored by Niklas Ingemann Nielsen. Completed at 1 site in Denmark. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-02-02.

Sponsored by Niklas Ingemann Nielsen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Knee Arthroplasty
  • Hip Arthroplasty
  • Postoperative Anaesthesia Care Unit
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 600 is above the median of 100 across 791 observational studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

This is the only study on the registry with Niklas Ingemann Nielsen as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (actual)
Target follow-up
90 Days
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Bypassing PACU

    Number of patients in need of secondary relocation to the Post Anaesthesia Care unit after knee and hip arthroplasty.

    Time frame: Within the first 24 hours.

Secondary outcomes

  1. 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.

    Time frame: 2 hours after surgery.

  2. 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.

    Time frame: 24 hours after surgery.

  3. 30 day Follow-up.

    30 day follow-up after surgery, concerning readmission within 8 days after surgery, length of stay and mortality.

    Time frame: 30 days

  4. 90 day Follow-up.

    90 day follow-up after surgery concerning readmission and mortality.

    Time frame: 90 days

  5. 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.

    Time frame: 90 days

07

Study locations

1 site
  • Hvidovre Hospital, Capital Region of Denmark.
    Hvidovre, 2650, Denmark
08

References and documents

Individual participant data

Plan to share: Undecided — Planned sharing data upon request.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03984942
Lead sponsor
Niklas Ingemann Nielsen
Collaborators
Rigshospitalet, Denmark
Responsible party
Niklas Ingemann Nielsen (Principal Investigator, Copenhagen University Hospital, Hvidovre) — Sponsor-investigator
First posted
Jun 13, 2019
Start date
Oct 1, 2019
Primary completion
Nov 1, 2020
Completion
Nov 1, 2020
Last update
Feb 2, 2021

Study contacts

Eske Aasvang, Dr.Med.
study director · Centre for abdominal surgery, rigshospitalet.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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