A Phase 3 interventional study of Continuous non-invasive blood pressure monitoring in Hip Fractures, Hypotension on Induction and Intraoperative Hypotension, sponsored by University Hospital Birmingham NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by University Hospital Birmingham NHS Foundation Trust · Phase 3, Interventional, and Prevention
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Among 39 studies in Hip Fractures with a site in United Kingdom — 7 open to participants now, 9 under way, none of them phase 3. Hip Fractures · United Kingdom.
Among the 39 studies in Hip Fractures with a site in United Kingdom, this one is the 26th largest by enrollment of the 27 interventional ones that give a count, is one of 2 that started in 2019, is one of 3 in phase 3, and was the 21st registered.
842 studies on the registry are indexed under Hip Fractures; 165 are open to participants now.
Browse Hip Fractures studies →7 of the 39 studies in Hip Fractures with a site in United Kingdom are open now. Recruiting first, the newest first:
Queen Mary University of London · Sites in United Kingdom
Ages 60–120
University of Southern California · Sites in United Kingdom, United States, Canada and 2 more countries
Ages 60+
Sheffield Teaching Hospitals NHS Foundation Trust · Sites in United Kingdom
Ages 18+
Teesside University · Sites in United Kingdom
Ages 60+
Population Health Research Institute · Sites in United Kingdom, United States, Australia and 17 more countries
Ages 45+
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 104 Hip Fractures studies recruiting now, 82 (79%) set no upper age limit and 6 (6%) stop at 75 or younger; 12 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
39 studies; the count open now beside each. This study's row is marked.
First in 1995; this study’s year is marked. 2 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 30 is below the median of 86 across 533 interventional studies indexed under Hip Fractures.
Median enrollment 251 across the 27 interventional studies, 58 across the 12 observational. Of the 27 that completed or were terminated, 2 (7%) have results posted.
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9 of 39 have an industry lead sponsor. The 10 most frequent:
University Hospital Birmingham NHS Foundation Trust is the lead sponsor of 36 studies on the registry; 1 is open to participants now.
University Hospital Birmingham NHS Foundation Trust has 1 study filed under Hip Fractures — fewer than ten, so there is no comparison to draw.
4 of the studies in Hip Fractures with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04113044AO Innovation Translation CenterGo Fit Fast, Recovery Trajectory Using PROMIS®, Linking PROMIS® | 2026-12-31 |
| NCT04796350AgNovos Healthcare, LLCRESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures | 2027-04-01 |
| NCT04743765Population Health Research InstituteHIP Fracture Accelerated Surgical TreaTment And Care tracK 2 Trial | 2027-08-31 |
| NCT06937372Queen Mary University of LondonDelivery and Implementation of a Randomised Crossover Trial on Thrombosis | 2027-10-31 |
Add all 4 to your calendar (.ics) → With an account.
Among the 39 studies in Hip Fractures with a site in United Kingdom, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Background During anaesthesia for repair of a broken hip, many patients experience low blood pressure. There have been many studies showing that patients who experience low blood pressure during anaesthesia are at increased risk of sustaining kidney or heart damage, strokes, having a post-operative infection, or dying. During anaesthesia, in most cases blood pressure is monitored using a cuff which inflates on the arm (the 'normal' way blood pressure is measured in a GP practice or hospital ward). This gives a reading each time the cuff goes up and down, every 3-5 minutes typically. There is a less well used way to measure blood pressure, using an additional cuff on the finger which gives a constant, continuous measure of blood pressure. We think that using this monitor, rather than the 'standard' monitor, will mean that low blood pressure is recognised more quickly, therefore treated more quickly, and will lead to patients having less exposure to dangerously low blood pressures. If this is the case, we hope that it will reduce how often patients experience kidney or heart damage, have an infection after surgery, suffer a stroke, and reduce the risk of death.
Methodology To test this, we would need to run a large clinical trial comparing the continuous monitor to the standard monitor. This would be expensive and involve a great deal of work in a large number of hospitals, and so first we wish to determine whether the trial we would like to run is practical, and possible to deliver in the real world. To do this we plan to run the trial first on a small-scale feasibility (pilot) study, where we will recruit 30 patients, half of whom will have the standard monitor, and half of whom will have the continuous monitor. We will see what proportion of the patients who could enter the trial actually do so and complete it, and use it as an opportunity to iron out problems with the trial. If we find it is possible to run the trial on a small scale, we will apply for funding to run a full study. This will aim to answer the question of whether the continuous monitor improves the patient outcomes which were agreed during development with the patient public involvement group locally; rate of kidney damage, heart damage, stroke, post-operative infections, risk of death, and hospital length-of-stay.
Expected outcomes and implications. We anticipate we will find the trial to be feasible with amendments to the way it is run, and if this is the case, we will apply to run the full scale trial. If this shows that using the continuous monitor improves the patient outcomes above, then it would represent new, significant evidence that may lead to the NHS adopting it's use as 'standard care' during anaesthesia for repair of a broken hip, and would like lead to similar trials in other operations where patients may benefit in a similar way.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CNAP monitoring applied, but screen and information not visible to treating anaesthetist
Device: Continuous non-invasive blood pressure monitoring
CNAP monitoring applied and available in full to the treating anaesthetist
Device: Continuous non-invasive blood pressure monitoring
Continuous non-invasive blood pressure monitoring using CNAP
Feasibility Outcome - Proportion of recruited patients in whom CNAP was successfully applied and full data collected.
Proportion of recruited patients in whom CNAP was successfully applied and full data collected.
Time frame: Through to study completion, an average of 5-6 weeks per patient.
Feasibility Outcome - Proportion of eligible patients successfully recruited
The proportion of all those patients who are eligible during the recruitment period who are successfully enrolled into the trial.
Time frame: Through to study completion, an average of 5-6 weeks per patient.
Feasibility Outcome - Proportion of enrolled patients in whom there is a full data set recorded.
Time frame: Through to study completion, an average of 5-6 weeks per patient.
Feasibility Outcome - Proportion of enrolled patients in which we are able to record full follow up data.
Time frame: Through to study completion, an average of 5-6 weeks per patient.
Intraoperative Outcomes - Nadir Blood Pressure
The lowest mean arterial pressure recorded during surgery using the CNAP monitor
Time frame: On the day of surgery only.
Intraoperative Outcomes - Total time spent with a mean arterial pressure <80mmHg
Time frame: On the day of surgery only.
Intraoperative Outcomes - Total time spent with a mean arterial pressure <65mmHg
Time frame: On the day of surgery only.
Intraoperative Outcomes - Total time spent with a mean arterial pressure <55mmHg
Time frame: On the day of surgery only.
Intraoperative Outcomes - Total volume of intravenous fluids given
Time frame: On the day of surgery only.
Intraoperative Outcomes - Total dose of vasopressors given
Broken down into totals of each separate vasopressor used.
Time frame: On the day of surgery only.
Post-operative Outcomes - Incidence of acute kidney injury in the 7 days post-operatively
Outcomes as per standardised definitions from the European Perioperative Clinical Outcome standards
Time frame: Assessed up to 7 days post-operatively.
Post-operative Outcomes - Incidence of myocardial injury in the first 3 days after surgery
Outcomes as per standardised definitions from the European Perioperative Clinical Outcome standards
Time frame: Assessed up to 3 days post-operatively.
Post-operative Outcomes - Incidence of stroke post-operatively
Outcomes as per standardised definitions from the European Perioperative Clinical Outcome standards
Time frame: Assessed up to 30 days post-operatively.
Post-operative Outcomes - Incidence of post-operative surgical site infection
As per CDC definitions
Time frame: Assessed up to 30 days post-operatively.
Post-operative Outcomes - Mortality
Time frame: Assessed at 30 days post-operatively.
Health Economic Outcome - Hospital Length of Stay
Time frame: Assessed at hospital discharge, an average of 10-14 days
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2019 to primary completion in Aug 2019, 1 month.
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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University Hospital Birmingham NHS Foundation Trust