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
130 participants
OBSERVATIONAL
2012-06-30
2014-02-28
Brief Summary
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No previous study has systematically tested algorithms deriving respiratory rate from either the ECG or the photoplethysmography (PPG) waveforms in a real -world setting.
The algorithms work by looking for changes in intervals between heartbeats and also changes in the sizes of the ECG and PPG waveforms, both of which may be caused by respiration. These changes tend to diminish with increasing age and also conditions which alter the chest movement and cardiac reflexes. Thus it is important to test our algorithms' accuracy in participants exhibiting these conditions. It is also important to ensure that the calculations of respiratory rate are accurate across a range of heart rates and respiratory rates. Our testing covers all these variables.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Young Healthy Volunteers
Healthy volunteers under the age of 40
Recording of 12 lead ECG
Recording of 12 lead ECG
Recording of lying and standing blood pressure
Recording of lying and standing blood pressure
Recording of chest wall movement
Recording of chest wall movement
Recording of heart rate variability
Done during deep breathing and a valsalva manoeuvre
Recording of ECG and Pulse oximeter waveform at rest
For 10 mins
Recording of ECG and Pulse oximeter waveform during exercise
Recording of ECG and Pulse oximeter waveform during exercise
Older healthy volunteers
Healthy volunteers over the age of 70
Recording of 12 lead ECG
Recording of 12 lead ECG
Recording of lying and standing blood pressure
Recording of lying and standing blood pressure
Recording of chest wall movement
Recording of chest wall movement
Recording of heart rate variability
Done during deep breathing and a valsalva manoeuvre
Recording of ECG and Pulse oximeter waveform at rest
For 10 mins
Patients with atrial fibrillation
Patients with permanent AF
Recording of 12 lead ECG
Recording of 12 lead ECG
Recording of lying and standing blood pressure
Recording of lying and standing blood pressure
Recording of chest wall movement
Recording of chest wall movement
Recording of heart rate variability
Done during deep breathing and a valsalva manoeuvre
Recording of ECG and Pulse oximeter waveform at rest
For 10 mins
Patients with a pacemaker
Patients who have an implanted pacemaker that is continually pacing
Recording of 12 lead ECG
Recording of 12 lead ECG
Recording of lying and standing blood pressure
Recording of lying and standing blood pressure
Recording of chest wall movement
Recording of chest wall movement
Recording of heart rate variability
Done during deep breathing and a valsalva manoeuvre
Recording of ECG and Pulse oximeter waveform at rest
For 10 mins
Patients with restricted chest movement
Patients whose chest expansion is less than 2.5cm
Recording of 12 lead ECG
Recording of 12 lead ECG
Recording of lying and standing blood pressure
Recording of lying and standing blood pressure
Recording of heart rate variability
Done during deep breathing and a valsalva manoeuvre
Recording of ECG and Pulse oximeter waveform at rest
For 10 mins
Interventions
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Recording of 12 lead ECG
Recording of 12 lead ECG
Recording of lying and standing blood pressure
Recording of lying and standing blood pressure
Recording of chest wall movement
Recording of chest wall movement
Recording of heart rate variability
Done during deep breathing and a valsalva manoeuvre
Recording of ECG and Pulse oximeter waveform at rest
For 10 mins
Recording of ECG and Pulse oximeter waveform during exercise
Recording of ECG and Pulse oximeter waveform during exercise
Eligibility Criteria
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Inclusion Criteria
* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged between 18 and 40 years old.
* Older Healthy Volunteers
* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 70 years or above.
* Patients
* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18-70 years old.
* Participant has one of the following conditions:
* Atrial fibrillation
* A permanent pacemaker that is continuously active
* Reduced chest wall movement
* Inability to give informed consent
Exclusion Criteria
* Any condition which might increase the risk of exercise testing
* Any history of ischaemic heart disease
* Any history of heart failure
* Any structural heart disease (eg: valvular lesions, hypertrophic obstructive cardiomyopathy)
* Any abnormalities on a resting ECG
* Deep vein thrombosis diagnosed within the last 6 months or under active treatment
* Uncontrolled hypertension (systolic blood pressure \>220 mm Hg, diastolic \>120 mm Hg)
* Aortic aneurysm
* Aortic or cardiovascular surgery within 6 months of recruitment
* A family history of sudden cardiac death, congenital arrhythmia syndromes or cardiomyopathy
* Autonomic dysfunction, either previously diagnosed or upon testing by the research team
* Any condition involving the brain or spinal cord
* Diabetes
* Alcohol consumption \> 21 units/week for women and 28 units/week for men or a history of previous alcohol dependence.
* Acute kidney injury
* Chronic kidney disease stage 4 or 5
* Any condition causing hepatic dysfunction
* Presence of a permanent pacemaker (these participants would be eligible for the pacemaker group)
* Reduced chest wall movement (these participants would be eligible for the reduced chest movement group)
* Any acute infection requiring antibiotic treatment within 3 months of recruitment
* Any other surgery or illness requiring hospitalisation within 3 months of recruitment
* Currently taking any medication with the exception of analgesics or the oral contraceptive pill.
* Any wound or skin condition affecting the torso which may be affected by the application of adhesive ECG dots to the skin
* Pregnancy
* Inability to give informed consent
* Older Healthy Volunteers
* Any diagnosed condition primarily affecting the cardiovascular or respiratory systems
* Symptomatic autonomic dysfunction
* Orthostatic hypotension
* Any condition involving the brain or spinal cord
* Diabetes
* Alcohol consumption \> 21 units/week for women and 28 units/week for men or a history of previous alcohol dependence.
* Acute kidney injury
* Chronic kidney disease stage 4 or 5
* Any condition causing hepatic dysfunction
* Presence of a permanent pacemaker
* Chronic Obstructive Pulmonary Disease (COPD).
* Any muscular dystrophy
* Kyphosis
* Scoliosis
* Pectus excavatum
* Any disease involving the lungs or pleura
* Any acute infection requiring antibiotic treatment within 3 months of recruitment
* Any other surgery or illness requiring hospitalisation within 3 months of recruitment
* Currently taking any medication with the exception of analgesics or the oral contraceptive pill.
* Any wound or skin condition affecting the torso which may be affected by the application of adhesive ECG dots to the skin
* Pregnancy
* Inability to give informed consent
* Patients
* Any infection which would require isolation or barrier nursing according to the hospital's infection control policy
* Any wound or skin condition affecting the torso which may be affected by the application of adhesive ECG dots to the skin
* Requirement for any form of artificial ventilatory support, including oxygen therapy
18 Months
ALL
Yes
Sponsors
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Engineering and Physical Sciences Research Council, UK
OTHER
University of Oxford
OTHER
Guy's and St Thomas' NHS Foundation Trust
OTHER
Responsible Party
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Richard Beale
Clinical Director
Principal Investigators
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Richard Beale, MBBS, FRCA
Role: PRINCIPAL_INVESTIGATOR
Guy's and St Thomas' Foundation Trust
Locations
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St Thomas' Hospital
London, , United Kingdom
Countries
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Other Identifiers
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11/LO/1667
Identifier Type: -
Identifier Source: org_study_id
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