- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01178489
Recovery at the Post Anaesthetic Care Unit After Hip and Knee Arthroplasty
September 21, 2011 updated by: Troels Haxholdt Lunn, Hvidovre University Hospital
Recovery at the Post Anaesthetic Care Unit After Fast-track Hip and Knee Arthroplasty
To clarify patient related problems in the Post Anaesthetic Care Unit (PACU) immediately after fast-track hip and knee arthroplasty.
Study Overview
Status
Completed
Detailed Description
In this prospective, consecutive, observational cohort study we examine:
- Patient related problems in the PACU after hip and knee arthroplasty simply to answer the question "Why in PACU?", using a modified version of the national guidelines for patient observation in PACU.
- The time spent in PACU with the modified version of the national guidelines for patient observation in PACU.
- If the modified version of the national guidelines for patient observation in PACU results in patient related problems in the ward afterwards.
Study Type
Observational
Enrollment (Actual)
170
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hvidovre
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Copenhagen, Hvidovre, Denmark, 2650
- Hvidovre University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients undergoing primary, unilateral, total hip or knee arthroplasty
Description
Inclusion Criteria:
- primary, unilateral, total hip or knee arthroplasty by one of three surgeons using the same technique, and under spinal anaesthesia
Exclusion Criteria:
- Bilateral arthroplasty
- Revision arthroplasty
- General anaesthesia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Patients undergoing arthroplasty
Patients undergoing primary, unilateral, total hip or knee arthroplasty under spinal anaesthesia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time to meet PACU discharge criteria
Time Frame: 3 hours
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3 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Actual discharge time from PACU
Time Frame: 3 hours
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3 hours
|
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Clinical and logistic factors detaining patients in PACU
Time Frame: 3 hours
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3 hours
|
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Potential complications at the surgical ward
Time Frame: 24 hours
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24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Troels H Lunn, M.D., Hvidovre University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
August 9, 2010
First Submitted That Met QC Criteria
August 9, 2010
First Posted (Estimate)
August 10, 2010
Study Record Updates
Last Update Posted (Estimate)
September 22, 2011
Last Update Submitted That Met QC Criteria
September 21, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- H-1-2010-FSP (The Danish Ethics Committee)
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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