Validation of Respiration Rate Algorithms

NCT01472133 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2014-02-12

No results posted yet for this study

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. 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

Interventions

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

Sponsors & Collaborators

  • Engineering and Physical Sciences Research Council, UK

    collaborator OTHER
  • University of Oxford

    collaborator OTHER
  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Richard Beale, MBBS, FRCA · Guy's and St Thomas' Foundation Trust

Eligibility

Min Age
18 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01472133 on ClinicalTrials.gov