Validation of Respiration Rate Algorithms

This study has been completed.
Sponsor:
Collaborators:
Engineering and Physical Sciences Research Council, UK
University of Oxford
Information provided by (Responsible Party):
Richard Beale, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01472133
First received: October 20, 2011
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

Continuous accurate unobtrusive respiratory rate monitoring may lead to improved patient outcomes, as respiratory rate is thought to be a sensitive marker of patient deterioration. Currently systems are not suitable for long term monitoring, particularly in ambulant patients as they are too restrictive. To ensure that our algorithms are suitable for use in a clinical context we need to demonstrate their performance not only in the optimal situation, healthy volunteers at rest, but also in more challenging situations such as where the person being monitored is moving and also in patients who have conditions which may affect their physiology in such a way that the accuracy of the respiration rate estimation may be affected.

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.


Condition Intervention
Respiratory Rate
Pulse Oximetry
Other: Recording of 12 lead ECG
Other: Recording of lying and standing blood pressure
Other: Recording of chest wall movement
Other: Recording of heart rate variability
Other: Recording of ECG and Pulse oximeter waveform at rest
Other: Recording of ECG and Pulse oximeter waveform during exercise

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Respiration Rate Algorithms

Further study details as provided by Guy's and St Thomas' NHS Foundation Trust:

Primary Outcome Measures:
  • The coefficient of variation for each respiration rate algorithm [ Time Frame: 5-6 months ] [ Designated as safety issue: No ]

    The algorithms to be tested are:

    one which calculates respiration rate (RR) from ECG only, one which calculates RR from PPG only, one which calculates RR from simultaneous ECG and PPG



Secondary Outcome Measures:
  • The coefficient of variation for the respiration rate calculated from a second pulse oximeter [ Time Frame: 5-6 months ] [ Designated as safety issue: No ]
    Participants will wear two different PPG monitors to assess whether PPG monitors from different manufacturers introduce artefactual changes to the PPG morphology


Estimated Enrollment: 130
Study Start Date: June 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Young Healthy Volunteers
Healthy volunteers under the age of 40
Other: Recording of 12 lead ECG
Recording of 12 lead ECG
Other: Recording of lying and standing blood pressure
Recording of lying and standing blood pressure
Other: Recording of chest wall movement
Recording of chest wall movement
Other: Recording of heart rate variability
Done during deep breathing and a valsalva manoeuvre
Other: Recording of ECG and Pulse oximeter waveform at rest
For 10 mins
Other: 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
Other: Recording of 12 lead ECG
Recording of 12 lead ECG
Other: Recording of lying and standing blood pressure
Recording of lying and standing blood pressure
Other: Recording of chest wall movement
Recording of chest wall movement
Other: Recording of heart rate variability
Done during deep breathing and a valsalva manoeuvre
Other: Recording of ECG and Pulse oximeter waveform at rest
For 10 mins
Patients with atrial fibrillation
Patients with permanent AF
Other: Recording of 12 lead ECG
Recording of 12 lead ECG
Other: Recording of lying and standing blood pressure
Recording of lying and standing blood pressure
Other: Recording of chest wall movement
Recording of chest wall movement
Other: Recording of heart rate variability
Done during deep breathing and a valsalva manoeuvre
Other: 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
Other: Recording of 12 lead ECG
Recording of 12 lead ECG
Other: Recording of lying and standing blood pressure
Recording of lying and standing blood pressure
Other: Recording of chest wall movement
Recording of chest wall movement
Other: Recording of heart rate variability
Done during deep breathing and a valsalva manoeuvre
Other: 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
Other: Recording of 12 lead ECG
Recording of 12 lead ECG
Other: Recording of lying and standing blood pressure
Recording of lying and standing blood pressure
Other: Recording of heart rate variability
Done during deep breathing and a valsalva manoeuvre
Other: Recording of ECG and Pulse oximeter waveform at rest
For 10 mins

  Eligibility

Ages Eligible for Study:   18 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy volunteers and hospital outpatients

Criteria

Inclusion Criteria:

  • Young Healthy Volunteers

    • 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

Exclusion Criteria:

  • Young Healthy Volunteers

    • 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
    • More than one of the inclusion criteria. (ie: a patient may not have both atrial fibrillation and reduced chest wall movement and be eligible for this study)
    • Inability to give informed consent
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01472133

Locations
United Kingdom
St Thomas' Hospital
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Engineering and Physical Sciences Research Council, UK
University of Oxford
Investigators
Principal Investigator: Richard Beale, MBBS, FRCA Guy's and St Thomas' Foundation Trust
  More Information

No publications provided

Responsible Party: Richard Beale, Clinical Director, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01472133     History of Changes
Other Study ID Numbers: 11/LO/1667
Study First Received: October 20, 2011
Last Updated: February 11, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Respiration Rate
ECG
Pulse oximetry
Photoplethysmograph
PPG
Physiology

ClinicalTrials.gov processed this record on September 22, 2014