Hip FracturesPhase 3iSTABILISENCT04051073
Can Continuous Non-invasive Monitoring Improve Stability of Intraoperative Blood Pressure - A Feasibility Study.
A Phase 3 study testing Continuous non-invasive blood pressure monitoring in people with Hip Fractures and Hypotension on Induction, run by University Hospital Birmingham NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures, Hypotension on Induction, Intraoperative Hypotension
- What is being tested?
- Continuous non-invasive blood pressure monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jun 2019to 5 Aug 2019
- Phase
- Phase 3
- 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
Who may be able to join
- Provision of written informed consent
- Adult patients, undergoing surgical repair of neck of femur fracture
- Patient can understand and comprehend written and spoken English
- Patient's consultee can understand written and spoken English
Who cannot join
- American Society of Anaesthesiologists (ASA) Class I patients
- Patients with device-specific exclusions; atrial fibrillation, Raynauds syndrome or disease, peripheral vascular disease, scleroderma, an arteriovenous shunt, valvular heart disease.
- Patients in whom a blood pressure cuff cannot be safely inflated on both arms for any reason (for example, lymphoedema).
- Patients in whom the treating anaesthetist has judged they will require invasive arterial pressure monitoring.
- Patients declining consent
- Patients in whom the treating anaesthetist will use total intravenous anaesthesia (TIVA)
- Patients in whom there is a >20mmHg difference between non-invasive cuff mean arterial pressure measurements made on opposite arms.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
MIDRU, Birmingham Heartlands Hospital
Birmingham, West Midlands, B95SS
About this study
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.
- Conditions
- Hip Fractures, Hypotension on Induction, Intraoperative Hypotension, Acute Kidney Injury, Myocardial Ischemia, Wound Infection
- Being tested
- Continuous non-invasive blood pressure monitoring
- Medical subject headings
- Hip Fractures, Acute Kidney Injury, Myocardial Ischemia, Wound Infection, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous non-invasive blood pressure monitoringDevice
Continuous non-invasive blood pressure monitoring using CNAP
| Study group | Role | What they receive |
|---|---|---|
| Blinded | Sham comparator | CNAP monitoring applied, but screen and information not visible to treating anaesthetist Receives: Device: Continuous non-invasive blood pressure monitoring |
| Unblinded | Active comparator | CNAP monitoring applied and available in full to the treating anaesthetist Receives: Device: Continuous non-invasive blood pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through to study completion, an average of 5-6 weeks per patient.
Secondary outcomes (12)
Intraoperative Outcomes - Nadir Blood Pressure
The lowest mean arterial pressure recorded during surgery using the CNAP monitor
Measured: On the day of surgery only.
Intraoperative Outcomes - Total time spent with a mean arterial pressure <80mmHg
Measured: On the day of surgery only.
Intraoperative Outcomes - Total time spent with a mean arterial pressure <65mmHg
Measured: On the day of surgery only.
Intraoperative Outcomes - Total time spent with a mean arterial pressure <55mmHg
Measured: On the day of surgery only.
Intraoperative Outcomes - Total volume of intravenous fluids given
Measured: On the day of surgery only.
Intraoperative Outcomes - Total dose of vasopressors given
Broken down into totals of each separate vasopressor used.
Measured: 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
Measured: 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
Measured: 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
Measured: Assessed up to 30 days post-operatively.
Post-operative Outcomes - Incidence of post-operative surgical site infection
As per CDC definitions
Measured: Assessed up to 30 days post-operatively.
Post-operative Outcomes - Mortality
Measured: Assessed at 30 days post-operatively.
Health Economic Outcome - Hospital Length of Stay
Measured: Assessed at hospital discharge, an average of 10-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start13 Jun 2019
- Primary completion5 Aug 2019
- Study completion5 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Before-and-after
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Warwick
- Responsible party
- Principal investigator, William Rook, University of Warwick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051073
- Sponsor's protocol ID
- 2019003AN
- Acronym
- iSTABILISE
- Status last verified
- May 2022
- First submitted
- 26 Jul 2019
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Continuous Non-invasive Monitoring Improve Stability of Intraoperative Blood Pressure - A Feasibility Study.
- ClinicalTrials.gov ID
- NCT04051073
- Acronym / sponsor ID
- iSTABILISE / 2019003AN
- Conditions
- Hip Fractures, Hypotension on Induction, Intraoperative Hypotension, Acute Kidney Injury, Myocardial Ischemia, Wound Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital Birmingham NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Warwick
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 5 Aug 2019 (actual)
- Study completion
- 5 Aug 2019 (actual)
- First posted
- 9 Aug 2019 (actual)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Before-and-after
| Arm | Type | Receives |
|---|---|---|
| Blinded | Sham comparator | Device: Continuous non-invasive blood pressure monitoringCNAP monitoring applied, but screen and information not visible to treating anaesthetist |
| Unblinded | Active comparator | Device: Continuous non-invasive blood pressure monitoringCNAP monitoring applied and available in full to the treating anaesthetist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of written informed consent
- Adult patients, undergoing surgical repair of neck of femur fracture
- Patient can understand and comprehend written and spoken English
- Patient's consultee can understand written and spoken English
Key exclusion criteria (7 listed)
- American Society of Anaesthesiologists (ASA) Class I patients
- Patients with device-specific exclusions; atrial fibrillation, Raynauds syndrome or disease, peripheral vascular disease, scleroderma, an arteriovenous shunt, valvular heart disease.
- Patients in whom a blood pressure cuff cannot be safely inflated on both arms for any reason (for example, lymphoedema).
- Patients in whom the treating anaesthetist has judged they will require invasive arterial pressure monitoring.
- Patients declining consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous non-invasive blood pressure monitoringContinuous non-invasive blood pressure monitoring using CNAP | Device | Blinded, Unblinded |
Primary outcome
Feasibility Outcome - 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.
Proportion of recruited patients in whom CNAP was successfully applied and full data collected.
Feasibility Outcome - Proportion of eligible patients successfully recruited
Time frame: Through to study completion, an average of 5-6 weeks per patient.
The proportion of all those patients who are eligible during the recruitment period who are successfully enrolled into the trial.
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.
12 secondary outcomes
Intraoperative Outcomes - Nadir Blood Pressure
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
Time frame: On the day of surgery only.
Post-operative Outcomes - Incidence of acute kidney injury in the 7 days post-operatively
Time frame: Assessed up to 7 days post-operatively.
Post-operative Outcomes - Incidence of myocardial injury in the first 3 days after surgery
Time frame: Assessed up to 3 days post-operatively.
Post-operative Outcomes - Incidence of stroke post-operatively
Time frame: Assessed up to 30 days post-operatively.
Post-operative Outcomes - Incidence of post-operative surgical site infection
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
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 18 May 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Continuous non-invasive blood pressure monitoring in people with Hip Fractures and Hypotension on Induction, run by University Hospital Birmingham NHS Foundation Trust at 1 site 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 4 inclusion and 7 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 18 May 2022. 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Feasibility Outcome - 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.). The study lists 4 primary outcomes in all. 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 18 May 2022.