Can Continuous Non-invasive Monitoring Improve Stability of Intraoperative Blood Pressure - A Feasibility Study.

NCT ID: NCT04051073

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-13
• Study Completion Date: 2019-08-05

Brief 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 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; Perioperative/Postoperative Complications

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Blinded

CNAP monitoring applied, but screen and information not visible to treating anaesthetist

Group Type: SHAM_COMPARATOR

Continuous non-invasive blood pressure monitoring

Intervention Type: DEVICE

Continuous non-invasive blood pressure monitoring using CNAP

Unblinded

CNAP monitoring applied and available in full to the treating anaesthetist

Group Type: ACTIVE_COMPARATOR

Continuous non-invasive blood pressure monitoring

Intervention Type: DEVICE

Continuous non-invasive blood pressure monitoring using CNAP

Interventions

Continuous non-invasive blood pressure monitoring

Continuous non-invasive blood pressure monitoring using CNAP

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Provision of written informed consent

2. Adult patients, undergoing surgical repair of neck of femur fracture

3. Patient can understand and comprehend written and spoken English

4. Patient's consultee can understand written and spoken English

Exclusion Criteria

1. American Society of Anaesthesiologists (ASA) Class I patients

2. Patients with device-specific exclusions; atrial fibrillation, Raynauds syndrome or disease, peripheral vascular disease, scleroderma, an arteriovenous shunt, valvular heart disease.

3. Patients in whom a blood pressure cuff cannot be safely inflated on both arms for any reason (for example, lymphoedema).

4. Patients in whom the treating anaesthetist has judged they will require invasive arterial pressure monitoring.

5. Patients declining consent

6. Patients in whom the treating anaesthetist will use total intravenous anaesthesia (TIVA)

7. Patients in whom there is a >20mmHg difference between non-invasive cuff mean arterial pressure measurements made on opposite arms.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Warwick

OTHER

Sponsor Role: collaborator

University Hospital Birmingham NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

William Rook

Academic Clinical Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

MIDRU, Birmingham Heartlands Hospital

Birmingham, West Midlands, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2019003AN

Identifier Type: -

Identifier Source: org_study_id