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OpenTrials
Completed

NCT Number: NCT01472133

Validation of Respiration Rate Algorithms

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.

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Key information

Age range

18 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recording of 12 lead ECG

Other

Recording of 12 lead ECG

Recording of lying and standing blood pressure

Other

Recording of lying and standing blood pressure

Recording of chest wall movement

Other

Recording of chest wall movement

Recording of heart rate variability

Other

Done during deep breathing and a valsalva manoeuvre

Recording of ECG and Pulse oximeter waveform at rest

Other

For 10 mins

Recording of ECG and Pulse oximeter waveform during exercise

Other

Recording of ECG and Pulse oximeter waveform during exercise

Primary outcomes

  1. The coefficient of variation for each respiration rate algorithm

    Time frame: 5-6 months

    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 outcomes

  1. The coefficient of variation for the respiration rate calculated from a second pulse oximeter

    Time frame: 5-6 months

    Participants will wear two different PPG monitors to assess whether PPG monitors from different manufacturers introduce artefactual changes to the PPG morphology

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Collaborators

  • Engineering and Physical Sciences Research Council, UK
  • University of Oxford

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 16, 2011
Registry last updated
Feb 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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