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

NCT04051073 | Completed Phase 3

• 1 other identifier: 2019003AN
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Through to study completion, an average of 5-6 weeks per patient.

Secondary Outcomes (12)

• Intraoperative Outcomes - Nadir Blood Pressure

  On the day of surgery only.

• Intraoperative Outcomes - Total time spent with a mean arterial pressure <80mmHg

  On the day of surgery only.

• Intraoperative Outcomes - Total time spent with a mean arterial pressure <65mmHg

  On the day of surgery only.

• Intraoperative Outcomes - Total time spent with a mean arterial pressure <55mmHg

  On the day of surgery only.

• Intraoperative Outcomes - Total volume of intravenous fluids given

  On the day of surgery only.

Study Arms (2)

Blinded

SHAM COMPARATOR

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

Device: Continuous non-invasive blood pressure monitoring

Unblinded

ACTIVE COMPARATOR

CNAP monitoring applied and available in full to the treating anaesthetist

Device: Continuous non-invasive blood pressure monitoring

Interventions

Continuous non-invasive blood pressure monitoring DEVICE

Continuous non-invasive blood pressure monitoring using CNAP

Blinded; Unblinded

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Birmingham NHS Foundation Trust: lead
• University of Warwick: collaborator

Study Sites (1)

MIDRU, Birmingham Heartlands Hospital

Birmingham, West Midlands, B95SS, United Kingdom

Location

MeSH Terms

Conditions

Hip Fractures; Acute Kidney Injury; Myocardial Ischemia; Wound Infection; Postoperative Complications

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic Clinical Fellow

Model Details: Before-and-after

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: August 9, 2019
• Study Start: June 13, 2019
• Primary Completion: August 5, 2019
• Study Completion: August 5, 2019
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)