An observational study in Respiratory Rate and Pulse Oximetry, sponsored by Guy's and St Thomas' NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-12.
Sponsored by Guy's and St Thomas' NHS Foundation Trust · Observational
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.
Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 294 studies on the registry; 79 are open to participants now.
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Healthy volunteers and hospital outpatients
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Young Healthy Volunteers
Older Healthy Volunteers
Patients
Exclusion Criteria:
Young Healthy Volunteers
Older Healthy Volunteers
Patients
Healthy volunteers under the age of 40
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
Healthy volunteers over the age of 70
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 permanent AF
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 who have an implanted pacemaker that is continually pacing
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 whose chest expansion is less than 2.5cm
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
Recording of 12 lead ECG
Recording of lying and standing blood pressure
Recording of chest wall movement
Done during deep breathing and a valsalva manoeuvre
For 10 mins
Recording of ECG and Pulse oximeter waveform during exercise
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
Time frame: 5-6 months
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
Time frame: 5-6 months
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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