- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03984942
Bypass PACU in Knee and Hip Arthroplasty
Bypass Post-Anesthesia Care Unit(PACU) in Knee and Hip Arthroplasty - A Quality Cohort Study
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.
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hvidovre, Denmark, 2650
- Hvidovre Hospital, Capital Region of Denmark.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Planned elective unilateral primary Hip- og Knee-Arthroplasty and unicompartmental Knee-Arthroplasty.
- Above 18 years.
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bypassing PACU
Time Frame: Within the first 24 hours.
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative actions and interventions by nurses within 2 hours.
Time Frame: 2 hours after surgery.
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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.
|
|
Postoperative actions and interventions within 24 hours.
Time Frame: 24 hours after surgery.
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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.
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30 day Follow-up.
Time Frame: 30 days
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30 day follow-up after surgery, concerning readmission within 8 days after surgery, length of stay and mortality.
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30 days
|
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90 day Follow-up.
Time Frame: 90 days
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90 day follow-up after surgery concerning readmission and mortality.
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90 days
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Complications after surgery.
Time Frame: 90 days
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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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90 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Eske Aasvang, Dr.Med., Centre for abdominal surgery, rigshospitalet.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NBF_EKAa_01_2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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