Validation of Respiration Rate Algorithms

NCT01472133 | Completed

• 1 other identifier: 11/LO/1667
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Respiration Rate; ECG; Pulse oximetry; Photoplethysmograph; PPG; Physiology

Outcome Measures

Primary Outcomes (1)

• 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

  5-6 months

Secondary Outcomes (1)

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

  5-6 months

Study Arms (5)

Young Healthy Volunteers

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

Older healthy volunteers

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 atrial fibrillation

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 with a pacemaker

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 with restricted chest movement

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

Interventions

Recording of 12 lead ECG OTHER

Recording of 12 lead ECG

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 pressure OTHER

Recording of lying and standing blood pressure

Older healthy volunteers; Patients with a pacemaker; Patients with atrial fibrillation; Patients with restricted chest movement; Young Healthy Volunteers

Recording of chest wall movement OTHER

Recording of chest wall movement

Older healthy volunteers; Patients with a pacemaker; Patients with atrial fibrillation; Young Healthy Volunteers

Recording of heart rate variability OTHER

Done during deep breathing and a valsalva manoeuvre

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 rest OTHER

For 10 mins

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 exercise OTHER

Recording of ECG and Pulse oximeter waveform during exercise

Young Healthy Volunteers

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers and hospital outpatients

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• Engineering and Physical Sciences Research Council, UK: collaborator
• University of Oxford: collaborator

Study Sites (1)

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

Study Officials

• Richard Beale, MBBS, FRCA

  Guy's and St Thomas' Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: November 16, 2011
• Study Start: June 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 12, 2014

Record last verified: 2014-02

Locations

GB (1)