Status:
COMPLETED
Validation of Respiration Rate Algorithms
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Collaborating Sponsors:
Engineering and Physical Sciences Research Council, UK
University of Oxford
Conditions:
Respiratory Rate
Pulse Oximetry
Eligibility:
All Genders
18+ years
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2014
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT01472133
Start Date
June 1 2012
End Date
February 1 2014
Last Update
February 12 2014
Active Locations (1)
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1
St Thomas' Hospital
London, United Kingdom, SE1 7EH