Hip FracturesNCT01474824
Validation of Nexfin Cardiac Output in Elderly Patients With Hip Fracture
An observational study of Hip Fractures and Anesthesia, run by University of Nottingham at 2 sites in United Kingdom.
Trial summary
Measurement of how much blood the heart pumps may be useful in guiding how much intravenous fluid to give patients during surgery. The current monitors either require special drips (arterial and/or central lines) or a probe inserted into the oesophagus (food pipe) which may limit their use. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Hip Fractures, Anesthesia
- How many people
- 6 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2013to Oct 2013
- 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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients undergoing surgical repair of hip fracture
Who may be able to join
- Aged over 80
- Able to give their own informed consent
Who cannot join
- Severe valvular heart disease
- Taking lithium
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Brighton and Sussex University Hospitals
Brighton, Sussex, BN2 5BE
Nottingham University Hospitals
Nottingham, Notts, NG7 2UH
About this study
Official title: Validation of the Nexfin Non-invasive Cardiac Output Monitor in Patients Undergoing Hip Fracture Repair
Measurement of how much blood the heart pumps may be useful in guiding how much intravenous fluid to give patients during surgery. The current monitors either require special drips (arterial and/or central lines) or a probe inserted into the oesophagus (food pipe) which may limit their use. Newer monitors are available which are completely non-invasive and seem to work well in younger patients. Patients with hip fracture are elderly and frail. The investigators wish to see whether the newer non-invasive monitor works well enough compared to the current monitors in this group of patients. If it does this may allow more of these patients to be monitored in this way.
Read the detailed description
The investigators wish to compare the accuracy of the newer, non-invasive monitor (Nexfin) against a more established minimally invasive monitor (LiDCO). The LiDCO has a calibration system which allows the absolute accuracy of the Nexfin to be established.
- Conditions
- Hip Fractures, Anesthesia
- Keywords
- Cardiac output, Stroke volume
- Medical subject headings
- Hip Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Bias and limits of agreement of Nexfin recorded cardiac output compared with LiDCOplus
Analysis of agreement between Nexfin cardiac output and the calibrated cardiac output measured by LiDCOplus
Measured: During anaesthesia period of surgery - measurements will be complete within 30 minutes of starting anaesthesia
Secondary outcomes (3)
Bias and limits of agreement for change in cardiac output measured by Nexfin compared with LiDCO
Comparison of relative changes in cardiac output recorded by Nexfin and LiDCO in response to intra-anaesthesia / intra-operative events (fluid administration, drug administration)
Measured: During anaesthesia period of surgery - measurements will be complete within 30 minutes of starting anaesthesia
Utility of Nexfin monitor
Proportion of time during anaesthesia and surgery when a valid signal is obtained from the Nexfin device.
Measured: Intra-operative - average duration about 1 hour
Adverse events associated with Nexfin monitor
Recording of adverse events associated with use of the Nexfin monitor
Measured: Intra-operative - average duration about one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startJan 2013
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: Unable to recruit sufficient participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust, Brighton and Sussex University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Iain K Moppett, DM FRCA MRCP, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474824
- Sponsor's protocol ID
- 11090
- Other IDs
- 11/SW/0288
- Status last verified
- Dec 2014
- First submitted
- 14 Oct 2011
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wiles MD, Whiteley WJ, Moran CG, Moppett IK. The use of LiDCO based fluid management in patients undergoing hip fracture surgery under spinal anaesthesia: neck of femur optimisation therapy - targeted stroke volume (NOTTS): study protocol for a randomized controlled trial. Trials. 2011 Sep 28;12:213. doi: 10.1186/1745-6215-12-213.
PubMed 21955538
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Nexfin Non-invasive Cardiac Output Monitor in Patients Undergoing Hip Fracture Repair
- ClinicalTrials.gov ID
- NCT01474824
- Acronym / sponsor ID
- 11090
- Conditions
- Hip Fractures, Anesthesia
- Keywords
- Cardiac output, Stroke volume
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to recruit sufficient participants
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust, Brighton and Sussex University Hospitals NHS Trust
- Study start
- Jan 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 18 Nov 2011 (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.
Measurement of how much blood the heart pumps may be useful in guiding how much intravenous fluid to give patients during surgery. The current monitors either require special drips (arterial and/or central lines) or a probe inserted into the oesophagus (food pipe) which may limit their use. Newer monitors are available which are completely non-invasive and seem to work well in younger patients. Patients with hip fracture are elderly and frail. The investigators wish to see whether the newer non-invasive monitor works well enough compared to the current monitors in this group of patients. If it does this may allow more of these patients to be monitored in this way.
Detailed description
The investigators wish to compare the accuracy of the newer, non-invasive monitor (Nexfin) against a more established minimally invasive monitor (LiDCO). The LiDCO has a calibration system which allows the absolute accuracy of the Nexfin to be established.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients undergoing surgical repair of hip fracture
Key inclusion criteria (2 listed)
- Aged over 80
- Able to give their own informed consent
Key exclusion criteria (2 listed)
- Severe valvular heart disease
- Taking lithium
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
Bias and limits of agreement of Nexfin recorded cardiac output compared with LiDCOplus
Time frame: During anaesthesia period of surgery - measurements will be complete within 30 minutes of starting anaesthesia
Analysis of agreement between Nexfin cardiac output and the calibrated cardiac output measured by LiDCOplus
3 secondary outcomes
Bias and limits of agreement for change in cardiac output measured by Nexfin compared with LiDCO
Time frame: During anaesthesia period of surgery - measurements will be complete within 30 minutes of starting anaesthesia
Utility of Nexfin monitor
Time frame: Intra-operative - average duration about 1 hour
Adverse events associated with Nexfin monitor
Time frame: Intra-operative - average duration about one hour
Results and safety
The study was stopped early (reason given: Unable to recruit sufficient participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
- Background: PubMed 21955538Wiles MD, Whiteley WJ, Moran CG, Moppett IK. The use of LiDCO based fluid management in patients undergoing hip fracture surgery under spinal anaesthesia: neck of femur optimisation therapy - targeted stroke volume (NOTTS): study protocol for a randomized controlled trial. Trials. 2011 Sep 28;12:213. doi: 10.1186/1745-6215-12-213.
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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.
Iain K Moppett, DM FRCA MRCP principal investigator
University of Nottingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures and Anesthesia, run by University of Nottingham at 2 sites in United Kingdom.
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 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: stopped early, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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 was stopped early (reason given: Unable to recruit sufficient participants). Results are not available in the source record.
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?
Bias and limits of agreement of Nexfin recorded cardiac output compared with LiDCOplus (time frame: During anaesthesia period of surgery - measurements will be complete within 30 minutes of starting anaesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01474824, which also lists 1 linked publication.
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 4 Dec 2014; AzTrials last refreshed its copy on 8 Nov 2026.