Total Knee ReplacementNCT01189565
Continuous Postoperative Pulse Oximetry in Patients Presenting for Total Hip and Total Knee Replacement
An observational study of Total Knee Replacement, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the incidence of low levels of oxygen as determined by standard pulse oximetry monitor in patients who have had total hip or knee replacement/revision. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Knee Replacement
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Mar 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Joint Replacement
Who may be able to join
- Patients undergoing knee replacement or hip replacement/revision
Who cannot join
- Patients requiring mechanical ventilation after surgery
- Patients with hemoglobinopathy that cause inaccurate pulse oximetry
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the incidence of low levels of oxygen as determined by standard pulse oximetry monitor in patients who have had total hip or knee replacement/revision.
- Conditions
- Total Knee Replacement
- Keywords
- Total Hip Replacement/Revision
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 |
|---|---|---|
| Joint Replacement Patients | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Investigators
- Matthew D McEvoy, M.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189565
- Sponsor's protocol ID
- HR-19772
- Status last verified
- Aug 2010
- First submitted
- 25 Aug 2010
- Last updated
- 22 May 2013
- Results posted
- No
Publications
Lawrence VA, Cornell JE, Smetana GW; American College of Physicians. Strategies to reduce postoperative pulmonary complications after noncardiothoracic surgery: systematic review for the American College of Physicians. Ann Intern Med. 2006 Apr 18;144(8):596-608. doi: 10.7326/0003-4819-144-8-200604180-00011.
PubMed 16618957McAlister FA, Bertsch K, Man J, Bradley J, Jacka M. Incidence of and risk factors for pulmonary complications after nonthoracic surgery. Am J Respir Crit Care Med. 2005 Mar 1;171(5):514-7. doi: 10.1164/rccm.200408-1069OC. Epub 2004 Nov 24.
PubMed 15563632Lawrence VA, Hilsenbeck SG, Mulrow CD, Dhanda R, Sapp J, Page CP. Incidence and hospital stay for cardiac and pulmonary complications after abdominal surgery. J Gen Intern Med. 1995 Dec;10(12):671-8. doi: 10.1007/BF02602761.
PubMed 8770719
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Postoperative Pulse Oximetry in Patients Presenting for Total Hip and Total Knee Replacement
- ClinicalTrials.gov ID
- NCT01189565
- Acronym / sponsor ID
- HR-19772
- Conditions
- Total Knee Replacement
- Keywords
- Total Hip Replacement/Revision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (actual)
- First posted
- 26 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.
The purpose of this study is to evaluate the incidence of low levels of oxygen as determined by standard pulse oximetry monitor in patients who have had total hip or knee replacement/revision.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Joint Replacement Patients | – | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Joint Replacement
Key inclusion criteria (1 listed)
- Patients undergoing knee replacement or hip replacement/revision
Key exclusion criteria (2 listed)
- Patients requiring mechanical ventilation after surgery
- Patients with hemoglobinopathy that cause inaccurate pulse oximetry
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
Not reported in the source record.
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 May 2013.
- Background: PubMed 16618957Lawrence VA, Cornell JE, Smetana GW; American College of Physicians. Strategies to reduce postoperative pulmonary complications after noncardiothoracic surgery: systematic review for the American College of Physicians. Ann Intern Med. 2006 Apr 18;144(8):596-608. doi: 10.7326/0003-4819-144-8-200604180-00011.
- Background: PubMed 15563632McAlister FA, Bertsch K, Man J, Bradley J, Jacka M. Incidence of and risk factors for pulmonary complications after nonthoracic surgery. Am J Respir Crit Care Med. 2005 Mar 1;171(5):514-7. doi: 10.1164/rccm.200408-1069OC. Epub 2004 Nov 24.
- Background: PubMed 8770719Lawrence VA, Hilsenbeck SG, Mulrow CD, Dhanda R, Sapp J, Page CP. Incidence and hospital stay for cardiac and pulmonary complications after abdominal surgery. J Gen Intern Med. 1995 Dec;10(12):671-8. doi: 10.1007/BF02602761.
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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.
Matthew D McEvoy, M.D. principal investigator
Medical University of South Carolina
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 Total Knee Replacement, run by Medical University of South Carolina at 1 site in United States.
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 2 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 May 2013. 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 United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01189565, which also lists 3 linked publications.
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 May 2013.