Respiratory RateNCT01472133
Validation of Respiration Rate Algorithms
An observational study of Respiratory Rate and Pulse Oximetry, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 months and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Rate, Pulse Oximetry
- What is being tested?
- Recording of 12 lead ECG, Recording of lying and standing blood pressure and Recording of chest wall movement
- How many people
- 130 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2012to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy volunteers and hospital outpatients
Who may be able to join
- 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.
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 55Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Respiratory Rate, Pulse Oximetry
- Being tested
- Recording of 12 lead ECG, Recording of lying and standing blood pressure, Recording of chest wall movement, Recording of heart rate variability, Recording of ECG and Pulse oximeter waveform at rest
- Keywords
- Respiration Rate, ECG, Pulse oximetry, Photoplethysmograph, PPG, Physiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recording of 12 lead ECGOther
Recording of 12 lead ECG
Recording of lying and standing blood pressureOther
Recording of lying and standing blood pressure
Recording of chest wall movementOther
Recording of chest wall movement
Recording of heart rate variabilityOther
Done during deep breathing and a valsalva manoeuvre
Recording of ECG and Pulse oximeter waveform at restOther
For 10 mins
Recording of ECG and Pulse oximeter waveform during exerciseOther
Recording of ECG and Pulse oximeter waveform during exercise
| Study group | Role | What they receive |
|---|---|---|
| Young Healthy Volunteers | Healthy volunteers under the age of 40 Receives: 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 | |
| Older healthy volunteers | Healthy volunteers over the age of 70 Receives: 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 | |
| Patients with atrial fibrillation | Patients with permanent AF Receives: 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 | |
| Patients with a pacemaker | Patients who have an implanted pacemaker that is continually pacing Receives: 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 | |
| Patients with restricted chest movement | Patients whose chest expansion is less than 2.5cm Receives: Other: Recording of 12 lead ECG; Other: Recording of lying and standing blood pressure; Other: Recording of heart rate variability; Other: Recording of ECG and Pulse oximeter waveform at rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
The coefficient of variation for each respiration rate algorithm
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
Measured: 5-6 months
Secondary outcomes (1)
The coefficient of variation for the respiration rate calculated from a second pulse oximeter
Participants will wear two different PPG monitors to assess whether PPG monitors from different manufacturers introduce artefactual changes to the PPG morphology
Measured: 5-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startJun 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Engineering and Physical Sciences Research Council, UK, University of Oxford
- Responsible party
- Principal investigator, Richard Beale, Guy's and St Thomas' NHS Foundation Trust
- Investigators
- Richard Beale, MBBS, FRCA, Principal investigator, Guy's and St Thomas' Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472133
- Sponsor's protocol ID
- 11/LO/1667
- Status last verified
- Feb 2014
- First submitted
- 20 Oct 2011
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Respiration Rate Algorithms
- ClinicalTrials.gov ID
- NCT01472133
- Acronym / sponsor ID
- 11/LO/1667
- Conditions
- Respiratory Rate, Pulse Oximetry
- Keywords
- Respiration Rate, ECG, Pulse oximetry, Photoplethysmograph, PPG, Physiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Engineering and Physical Sciences Research Council, UK, University of Oxford
- Study start
- Jun 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 16 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Young Healthy Volunteers | – | 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 exerciseHealthy volunteers under the age of 40 |
| Older healthy volunteers | – | 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 restHealthy volunteers over the age of 70 |
| Patients with atrial fibrillation | – | 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 restPatients with permanent AF |
| Patients with a pacemaker | – | 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 restPatients who have an implanted pacemaker that is continually pacing |
| Patients with restricted chest movement | – | Other: Recording of 12 lead ECG, Other: Recording of lying and standing blood pressure, Other: Recording of heart rate variability, Other: Recording of ECG and Pulse oximeter waveform at restPatients whose chest expansion is less than 2.5cm |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy volunteers and hospital outpatients
Key inclusion criteria (13 listed)
- Young Healthy Volunteers
- Older Healthy Volunteers
- Patients
Key exclusion criteria (55 listed)
- Young Healthy Volunteers
- Older Healthy Volunteers
- Patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recording of 12 lead ECGRecording of 12 lead ECG | Other | Older healthy volunteers, Patients with a pacemaker, Patients with atrial fibrillation, Patients with restricted chest movement, Young Healthy Volunteers |
| Recording of lying and standing blood pressureRecording of lying and standing blood pressure | Other | Older healthy volunteers, Patients with a pacemaker, Patients with atrial fibrillation, Patients with restricted chest movement, Young Healthy Volunteers |
| Recording of chest wall movementRecording of chest wall movement | Other | Older healthy volunteers, Patients with a pacemaker, Patients with atrial fibrillation, Young Healthy Volunteers |
| Recording of heart rate variabilityDone during deep breathing and a valsalva manoeuvre | Other | Older healthy volunteers, Patients with a pacemaker, Patients with atrial fibrillation, Patients with restricted chest movement, Young Healthy Volunteers |
| Recording of ECG and Pulse oximeter waveform at restFor 10 mins | Other | Older healthy volunteers, Patients with a pacemaker, Patients with atrial fibrillation, Patients with restricted chest movement, Young Healthy Volunteers |
| Recording of ECG and Pulse oximeter waveform during exerciseRecording of ECG and Pulse oximeter waveform during exercise | Other | Young Healthy Volunteers |
Primary outcome
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
1 secondary outcome
The coefficient of variation for the respiration rate calculated from a second pulse oximeter
Time frame: 5-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Beale, MBBS, FRCA principal investigator
Guy's and St Thomas' Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Rate and Pulse Oximetry, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 55 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The coefficient of variation for each respiration rate algorithm (time frame: 5-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2014.