SurgeryNCT03984942
Bypass PACU in Knee and Hip Arthroplasty
An observational study of Surgery and Knee Osteoarthritis, run by Niklas Ingemann Nielsen at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Surgery, Knee Osteoarthritis, Postoperative Complications
- How many people
- 600 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2019to 1 Nov 2020
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Planned elective unilateral primary Hip- og Knee-Arthroplasty and unicompartmental Knee-Arthroplasty.
- Above 18 years.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Surgery, Knee Osteoarthritis, Postoperative Complications, Hip Osteoarthritis, Arthroplasty Complications
- Keywords
- Knee Arthroplasty, Hip Arthroplasty, Postoperative Anaesthesia Care Unit
- Medical subject headings
- Osteoarthritis, Knee, Postoperative Complications, Osteoarthritis, Hip
What is being measured
The primary outcome is the main question the study is designed to answer.
Bypassing PACU
Number of patients in need of secondary relocation to the Post Anaesthesia Care unit after knee and hip arthroplasty.
Measured: Within the first 24 hours.
Secondary outcomes (5)
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.
Measured: 2 hours after surgery.
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.
Measured: 24 hours after surgery.
30 day Follow-up.
30 day follow-up after surgery, concerning readmission within 8 days after surgery, length of stay and mortality.
Measured: 30 days
90 day Follow-up.
90 day follow-up after surgery concerning readmission and mortality.
Measured: 90 days
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start1 Oct 2019
- Primary completion1 Nov 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Niklas Ingemann Nielsen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor-investigator, Niklas Ingemann Nielsen, Copenhagen University Hospital, Hvidovre
- Investigators
- Eske Aasvang, Dr.Med., Study director, Centre for abdominal surgery, rigshospitalet.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984942
- Sponsor's protocol ID
- NBF_EKAa_01_2019
- Status last verified
- Jan 2021
- First submitted
- 11 Jun 2019
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Planned sharing data upon request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bypass Post-Anesthesia Care Unit(PACU) in Knee and Hip Arthroplasty - A Quality Cohort Study
- ClinicalTrials.gov ID
- NCT03984942
- Acronym / sponsor ID
- NBF_EKAa_01_2019
- Conditions
- Surgery, Knee Osteoarthritis, Postoperative Complications, Hip Osteoarthritis, Arthroplasty Complications
- Keywords
- Knee Arthroplasty, Hip Arthroplasty, Postoperative Anaesthesia Care Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Niklas Ingemann NielsenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Planned elective unilateral primary Hip- og Knee-Arthroplasty and unicompartmental Knee-Arthroplasty.
- Above 18 years.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Postoperative actions and interventions by nurses within 2 hours.
Time frame: 2 hours after surgery.
Postoperative actions and interventions within 24 hours.
Time frame: 24 hours after surgery.
30 day Follow-up.
Time frame: 30 days
90 day Follow-up.
Time frame: 90 days
Complications after surgery.
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: Undecided. Planned sharing data upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eske Aasvang, Dr.Med. study director
Centre for abdominal surgery, rigshospitalet.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Knee Osteoarthritis, run by Niklas Ingemann Nielsen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bypassing PACU (time frame: Within the first 24 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.