Respiratory Rate
Conditions
Brief summary
The respiratory rate is an important parameter in clinical medicine. It is defined as the number of breaths per minute. Currently this is measured at the bedside in clinical practice by counting the breaths, however the gold standard for measuring this vital sign is the capnograph. For the patient, this involves wearing a tube in their nose and around their ears while trying to minimise their movement and talking so that the measurements can be taken. A new respiratory rate monitor, RespiraSense, is non-invasive and measures the respiratory rate by measuring the displacement between the ribs and abdomen. This research study is intended to validate that this technology is effective and accurate on people with a bigger body mass. Subjects with a BMI \> 35 will be invited to participate should they meet all of the eligibility criteria. If patients agree to participate, following informed consent, subjects will be monitored for one hour with both the capnograph and RespiraSense measuring at the same time so their results can be compared
Interventions
DEVICERespiraSense Respiratory Rate Monitor
RespiraSense device will be attached at the same time as the capnograph (gold standard) and both will measure simultaneously for one hour
Sponsors
PMD Solutions
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* ≥ 18 Years * Have a BMI ≥35 * For the sub-group analysis at least 5 subjects with a BMI 35-49 and at least 5 BMI \> 50 will be needed * Are willing to voluntarily sign a statement of informed consent to participate in this investigation
Exclusion criteria
* Allergic to medical grade skin adhesive * Continuous oral long term steroid use. To be free from oral steroid use this is defined as not using oral steroids in the 4 weeks previous to enrolment * Patients under the influence of substance abuse (drug or alcohol) that may interfere with their ability to cooperate and comply with the investigation procedures * Any disorder, including cognitive dysfunction, which would affect the ability to accurately complete questionnaires and freely give full informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of PMD RespiraSense against capnography in obese patients. | 1 hour | Analysed using a Bland Altman (BA) analysis to measure limits of agreement between both methods. The BA analysis will correct for repeated measures within each subject if required. In addition, a Deming Regression will be performed on the collected data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of PMD RespiraSense in obese patients with BMI below 50 and those with BMI of 50 or above. | 1 hour | Analysed using a Bland Altman (BA) analysis to measure limits of agreement between both methods. The BA analysis will correct for repeated measures within each subject if required. In addition, a Deming Regression will be performed on the collected data. |
| Identification of any accuracy spread patterns as BMI increases. | 1 hour | Analysed using a Bland Altman (BA) analysis to measure limits of agreement between both methods. The BA analysis will correct for repeated measures within each subject if required. In addition, a Deming Regression will be performed on the collected data. |
| Collection of feedback on device comfort when worn by patients with high BMI. | 1 hour | Will not be analysed formally. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory: To measure RespiraSense device alarm generation and assess the rationale behind these to determine if false alarms and therefore alarm fatigue is occurring | 1 hour | Will not be analysed formally. |
Countries
United Kingdom
Outcome results
None listed