Feasibility Study of a New Peripheral Oedema Monitor for Heart Failure
NCT ID: NCT02993601
Last Updated: 2021-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
70 participants
OBSERVATIONAL
2017-01-15
2017-06-13
Brief Summary
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During the study, this measurement will be compared to clinical standard and gold standard measurements as well as clinical grading of peripheral oedema.
Detailed Description
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The study has two general aims:
The first is to collect a time-series of data on inpatients with peripheral oedema caused by heart failure, as they receive intravenous or oral diuretic treatment to remove excess fluid and achieve optimal body weight and fluid balance. This data will be used both to determine the attainable resolution of foot biometric measurements on a patient as their fluid status changes, and also to further develop the algorithms used in the device and make them usable on a wide range of feet/lower legs which have been deformed by oedema. The data required for this study are images taken using the Heartfelt-1 device, as well as validation measurements such as the figure of eight using a medical grade tape measure, callipers, or the water displacement method using a volumetric gauge, at multiple time-points whilst the peripheral oedema reduces.
The second, on a second group of stable ambulatory (Heart Failure) HF patients with variable levels of oedema, is to evaluate the performance of the Heartfelt-1 device in determining foot biometric parameters one a wide range of patients at a single point in time. Patients with stable chronic heart failure will have their foot/lower legs measured by the Heartfelt-1 device, as well as standard medical measurement (figure of eight using a medical grade tape measure, callipers) and gold standard measurement (water displacement method using a gauge), as well as the patient's weight and a clinical grading of oedema. These will be compared and an estimate of the accuracy of the Heartfelt-1 device over this wider patient group can be extrapolated.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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20 outpatients with peripheral oedema
20 outpatients with clinically detectable peripheral oedema for 1 set of measurements.
Heartfelt-1
The patients will stand in front of the Heartfelt-1 in order for images to be captured and the volume of their lower legs measured.
Weighing scales
The patient will be asked to stand on standard medical weighing scales, to measure their weight.
Medical grading of oedema
A member of the research team will assess the severity of the peripheral oedema on a scale of 1-5.
Baseline assessements
At the point study participants are recruited, their age, sex, diagnosis, aetiology of heart failure, LVEF (Left ventricular ejection fraction), medical and device therapy, time since diagnosis, BNP (B-type Natriuretic Peptide), CRP (C-Reactive Protein), renal function (EGFR), Haemoglobin, albumin and urinalysis will be assessed unless recent (less that 6 months old) results are available. The number of Heart failure hospital admissions in the last 2 years, LACE score, co-morbidities will also be noted.
Water displacement method
This will involve filling a gauge with lukewarm water (27-35oC +-2oC) up to the appropriate level. The appropriate level is determined by the water stabilising after some has flown out of the gauge into the waste bucket. Once the water level is stable the patient, who is sitting on a chair will be gently plunging the foot (naked) in the gauge until their foot is flat on the bottom on the gauge. The water flowing out of the gauge into the measuring bucket will be collected until the flow of water stops. Four small marks with non-toxic /non-permanent pen will be made on the lower leg of the patient to indicate where the water level was at. The water which has been collected in the measuring bucket will be weighted with precision scales to determine the volume of water displaced by the insertion of the foot. The patient's foot will then be dried.
Callipers measurements
This will involve making 4 marks on one of the foot/lower leg (small cross) using non-toxic / non- permanent pen. The measurement will consist of making 6 measurements between those marks using callipers, and reporting the distance on a calibrated tape.
Measuring tape
The measurements taken using a medical tape measure will involve the circumference of the ankle to be measured as well as the circumference at the level of the arch of the foot. The medical tape used will be a CE marked disposable medical measuring tape to minimise the risk of infection. The measurements will be done on both feet.
20 cardiology controls
20 outpatients with heart failure without clinically detectable peripheral oedema (control group) for 1 set of measurements.
Heartfelt-1
The patients will stand in front of the Heartfelt-1 in order for images to be captured and the volume of their lower legs measured.
Weighing scales
The patient will be asked to stand on standard medical weighing scales, to measure their weight.
Medical grading of oedema
A member of the research team will assess the severity of the peripheral oedema on a scale of 1-5.
Baseline assessements
At the point study participants are recruited, their age, sex, diagnosis, aetiology of heart failure, LVEF (Left ventricular ejection fraction), medical and device therapy, time since diagnosis, BNP (B-type Natriuretic Peptide), CRP (C-Reactive Protein), renal function (EGFR), Haemoglobin, albumin and urinalysis will be assessed unless recent (less that 6 months old) results are available. The number of Heart failure hospital admissions in the last 2 years, LACE score, co-morbidities will also be noted.
Water displacement method
This will involve filling a gauge with lukewarm water (27-35oC +-2oC) up to the appropriate level. The appropriate level is determined by the water stabilising after some has flown out of the gauge into the waste bucket. Once the water level is stable the patient, who is sitting on a chair will be gently plunging the foot (naked) in the gauge until their foot is flat on the bottom on the gauge. The water flowing out of the gauge into the measuring bucket will be collected until the flow of water stops. Four small marks with non-toxic /non-permanent pen will be made on the lower leg of the patient to indicate where the water level was at. The water which has been collected in the measuring bucket will be weighted with precision scales to determine the volume of water displaced by the insertion of the foot. The patient's foot will then be dried.
Callipers measurements
This will involve making 4 marks on one of the foot/lower leg (small cross) using non-toxic / non- permanent pen. The measurement will consist of making 6 measurements between those marks using callipers, and reporting the distance on a calibrated tape.
Measuring tape
The measurements taken using a medical tape measure will involve the circumference of the ankle to be measured as well as the circumference at the level of the arch of the foot. The medical tape used will be a CE marked disposable medical measuring tape to minimise the risk of infection. The measurements will be done on both feet.
10 in-patients peripheral oedema
10 in patients hospitalised as a result of heart failure and fluid congestion with peripheral oedema, those patients will have several sets of measurements taken over time to measure the reduction of peripheral oedema which is likely to show common features with the formation of peripheral oedema.
Heartfelt-1
The patients will stand in front of the Heartfelt-1 in order for images to be captured and the volume of their lower legs measured.
Weighing scales
The patient will be asked to stand on standard medical weighing scales, to measure their weight.
Medical grading of oedema
A member of the research team will assess the severity of the peripheral oedema on a scale of 1-5.
Baseline assessements
At the point study participants are recruited, their age, sex, diagnosis, aetiology of heart failure, LVEF (Left ventricular ejection fraction), medical and device therapy, time since diagnosis, BNP (B-type Natriuretic Peptide), CRP (C-Reactive Protein), renal function (EGFR), Haemoglobin, albumin and urinalysis will be assessed unless recent (less that 6 months old) results are available. The number of Heart failure hospital admissions in the last 2 years, LACE score, co-morbidities will also be noted.
Water displacement method
This will involve filling a gauge with lukewarm water (27-35oC +-2oC) up to the appropriate level. The appropriate level is determined by the water stabilising after some has flown out of the gauge into the waste bucket. Once the water level is stable the patient, who is sitting on a chair will be gently plunging the foot (naked) in the gauge until their foot is flat on the bottom on the gauge. The water flowing out of the gauge into the measuring bucket will be collected until the flow of water stops. Four small marks with non-toxic /non-permanent pen will be made on the lower leg of the patient to indicate where the water level was at. The water which has been collected in the measuring bucket will be weighted with precision scales to determine the volume of water displaced by the insertion of the foot. The patient's foot will then be dried.
Callipers measurements
This will involve making 4 marks on one of the foot/lower leg (small cross) using non-toxic / non- permanent pen. The measurement will consist of making 6 measurements between those marks using callipers, and reporting the distance on a calibrated tape.
Measuring tape
The measurements taken using a medical tape measure will involve the circumference of the ankle to be measured as well as the circumference at the level of the arch of the foot. The medical tape used will be a CE marked disposable medical measuring tape to minimise the risk of infection. The measurements will be done on both feet.
30 control without cardiac conditions
less than 30 normal controls (healthy volunteers and patients without heart failure) in the age group 55 and above who agree to have images taken using the Heartfelt-1 device (not the whole set of measurements).
Heartfelt-1
The patients will stand in front of the Heartfelt-1 in order for images to be captured and the volume of their lower legs measured.
Interventions
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Heartfelt-1
The patients will stand in front of the Heartfelt-1 in order for images to be captured and the volume of their lower legs measured.
Weighing scales
The patient will be asked to stand on standard medical weighing scales, to measure their weight.
Medical grading of oedema
A member of the research team will assess the severity of the peripheral oedema on a scale of 1-5.
Baseline assessements
At the point study participants are recruited, their age, sex, diagnosis, aetiology of heart failure, LVEF (Left ventricular ejection fraction), medical and device therapy, time since diagnosis, BNP (B-type Natriuretic Peptide), CRP (C-Reactive Protein), renal function (EGFR), Haemoglobin, albumin and urinalysis will be assessed unless recent (less that 6 months old) results are available. The number of Heart failure hospital admissions in the last 2 years, LACE score, co-morbidities will also be noted.
Water displacement method
This will involve filling a gauge with lukewarm water (27-35oC +-2oC) up to the appropriate level. The appropriate level is determined by the water stabilising after some has flown out of the gauge into the waste bucket. Once the water level is stable the patient, who is sitting on a chair will be gently plunging the foot (naked) in the gauge until their foot is flat on the bottom on the gauge. The water flowing out of the gauge into the measuring bucket will be collected until the flow of water stops. Four small marks with non-toxic /non-permanent pen will be made on the lower leg of the patient to indicate where the water level was at. The water which has been collected in the measuring bucket will be weighted with precision scales to determine the volume of water displaced by the insertion of the foot. The patient's foot will then be dried.
Callipers measurements
This will involve making 4 marks on one of the foot/lower leg (small cross) using non-toxic / non- permanent pen. The measurement will consist of making 6 measurements between those marks using callipers, and reporting the distance on a calibrated tape.
Measuring tape
The measurements taken using a medical tape measure will involve the circumference of the ankle to be measured as well as the circumference at the level of the arch of the foot. The medical tape used will be a CE marked disposable medical measuring tape to minimise the risk of infection. The measurements will be done on both feet.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients attending cardiology outpatients at the Royal Brompton hospital with a diagnosis of heart failure and fluid retention.
* Cardiology patient without fluid retention (cardiology controls) Non-Cardiology patient without fluid retention (controls)
Exclusion Criteria
* Unstable arrhythmias in previous 48 hours
* Systolic BP\<90mmHg or need for inotropic support
* Ulceration on lower limbs (below shin) - excluded from water displacement but could have image recording and calipers
* Inability to transfer from bed to chair
* Patients with broken skin or cellulitis will not have their foot volume measured using the water displacement equipment to reduce the risk of infection for the patient and other participants.
18 Years
99 Years
ALL
Yes
Sponsors
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Royal Brompton & Harefield NHS Foundation Trust
OTHER
Heartfelt Technologies
INDUSTRY
Responsible Party
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Principal Investigators
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Alexander Lyon, BCh PhD FRCP
Role: PRINCIPAL_INVESTIGATOR
Royal Brompton and Harefield NHS Foundation Trust
Locations
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Royal Brompton Hospital
London, , United Kingdom
Countries
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References
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Chausiaux O, Williams G, Nieznanski M, Bagdu A, Downer P, Keyser M, Husheer S. Evaluation of the Accuracy of a Video and AI Solution to Measure Lower Leg and Foot Volume. Med Devices (Auckl). 2021 Apr 13;14:105-118. doi: 10.2147/MDER.S297713. eCollection 2021.
Other Identifiers
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RBH01
Identifier Type: -
Identifier Source: org_study_id