PACU Stay After THA Under Spinal AnaesthesiaNCT01178489
Recovery at the Post Anaesthetic Care Unit After Hip and Knee Arthroplasty
An observational study of PACU Stay After THA Under Spinal Anaesthesia and PACU Stay After TKA Under Spinal Anaesthesia, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
To clarify patient related problems in the Post Anaesthetic Care Unit (PACU) immediately after fast-track hip and knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PACU Stay After THA Under Spinal Anaesthesia, PACU Stay After TKA Under Spinal Anaesthesia
- How many people
- 170 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2010to Jan 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing primary, unilateral, total hip or knee arthroplasty
Who may be able to join
- primary, unilateral, total hip or knee arthroplasty by one of three surgeons using the same technique, and under spinal anaesthesia
Who cannot join
- Bilateral arthroplasty
- Revision arthroplasty
- General anaesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing arthroplasty | Patients undergoing primary, unilateral, total hip or knee arthroplasty under spinal anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to meet PACU discharge criteria
Measured: 3 hours
Secondary outcomes (3)
Actual discharge time from PACU
Measured: 3 hours
Clinical and logistic factors detaining patients in PACU
Measured: 3 hours
Potential complications at the surgical ward
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PACU Stay After THA Under Spinal AnaesthesiaStudies 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
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Troels Haxholdt Lunn, Hvidovre University Hospital
- Investigators
- Troels H Lunn, M.D., Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178489
- Sponsor's protocol ID
- H-1-2010-FSP
- Status last verified
- Sep 2011
- First submitted
- 9 Aug 2010
- Last updated
- 22 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery at the Post Anaesthetic Care Unit After Fast-track Hip and Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01178489
- Acronym / sponsor ID
- H-1-2010-FSP
- Conditions
- PACU Stay After THA Under Spinal Anaesthesia, PACU Stay After TKA Under Spinal Anaesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 10 Aug 2010 (estimated)
- 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.
To clarify patient related problems in the Post Anaesthetic Care Unit (PACU) immediately after fast-track hip and knee arthroplasty.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing arthroplasty | – | –Patients undergoing primary, unilateral, total hip or knee arthroplasty under spinal anaesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing primary, unilateral, total hip or knee arthroplasty
Key inclusion criteria (1 listed)
- primary, unilateral, total hip or knee arthroplasty by one of three surgeons using the same technique, and under spinal anaesthesia
Key exclusion criteria (3 listed)
- Bilateral arthroplasty
- Revision arthroplasty
- General anaesthesia
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
Time to meet PACU discharge criteria
Time frame: 3 hours
3 secondary outcomes
Actual discharge time from PACU
Time frame: 3 hours
Clinical and logistic factors detaining patients in PACU
Time frame: 3 hours
Potential complications at the surgical ward
Time frame: 24 hours
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 22 Sep 2011.
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.
Troels H Lunn, M.D. principal investigator
Hvidovre University Hospital
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 PACU Stay After THA Under Spinal Anaesthesia and PACU Stay After TKA Under Spinal Anaesthesia, run by Hvidovre University Hospital 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 1 inclusion and 3 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 22 Sep 2011. 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?
Time to meet PACU discharge criteria (time frame: 3 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 22 Sep 2011.