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Bypass PACU in Knee and Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT03984942
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 21, 2019
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Niklas Ingemann Nielsen, Copenhagen University Hospital, Hvidovre

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.


Condition or disease
Surgery Knee Osteoarthritis Postoperative Complications Hip Osteoarthritis Arthroplasty Complications

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 90 Days
Official Title: Bypass Post-Anesthesia Care Unit(PACU) in Knee and Hip Arthroplasty - A Quality Cohort Study
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Bypassing PACU [ Time Frame: Within the first 24 hours. ]
    Number of patients in need of secondary relocation to the Post Anaesthesia Care unit after knee and hip arthroplasty.


Secondary Outcome Measures :
  1. Postoperative actions and interventions by nurses within 2 hours. [ Time Frame: 2 hours after surgery. ]

    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. Postoperative actions and interventions within 24 hours. [ Time Frame: 24 hours after surgery. ]

    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.


  3. 30 day Follow-up. [ Time Frame: 30 days ]
    30 day follow-up after surgery, concerning readmission within 8 days after surgery, length of stay and mortality.

  4. 90 day Follow-up. [ Time Frame: 90 days ]
    90 day follow-up after surgery concerning readmission and mortality.

  5. Complications after surgery. [ Time Frame: 90 days ]
    Complications after surgery, divided in medical and surgical complications with details of type of event and time of occurence as well as treatment.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984942


Contacts
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Contact: Niklas Ingemann Nielsen, MD 0045 38 62 06 75 Niklas.Ingemann.Nielsen@regionh.dk
Contact: Nicolai Bang Foss, Dr.Med. 0045 38 62 53 28 Nicolai.Bang.Foss@regionh.dk

Locations
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Denmark
Hvidovre Hospital, Capital Region of Denmark. Not yet recruiting
Hvidovre, Denmark, 2650
Contact: Niklas Ingemann Nielsen, MD    0045 28 29 34 88    Niklas.Ingemann.Nielsen@regionh.dk   
Contact: Nicolai Bang Foss, Dr.Med.    0045 38 62 53 28      
Principal Investigator: Niklas Ingemann Nielsen, MD         
Sponsors and Collaborators
Niklas Ingemann Nielsen
Rigshospitalet, Denmark
Investigators
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Study Director: Eske Aasvang, Dr.Med. Centre for abdominal surgery, rigshospitalet.

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Responsible Party: Niklas Ingemann Nielsen, Principal Investigator, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier: NCT03984942     History of Changes
Other Study ID Numbers: NBF_EKAa_01_2019
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Planned sharing data upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Niklas Ingemann Nielsen, Copenhagen University Hospital, Hvidovre:
Knee Arthroplasty
Hip Arthroplasty
Postoperative Anaesthesia Care Unit

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Postoperative Complications
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes