An observational study in Respiratory Rate, sponsored by PMD Solutions. Completed at 1 site in United Kingdom. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2019-03-20.
Sponsored by PMD Solutions · Observational
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
Obese patients with a BMI ≥35
Have a BMI ≥35
Exclusion Criteria:
RespiraSense device will be attached at the same time as the capnograph (gold standard) and both will measure simultaneously for one hour
Comparison of PMD RespiraSense against capnography in obese patients.
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.
Time frame: 1 hour
Comparison of PMD RespiraSense in obese patients with BMI below 50 and those with BMI of 50 or above.
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.
Time frame: 1 hour
Identification of any accuracy spread patterns as BMI increases.
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.
Time frame: 1 hour
Collection of feedback on device comfort when worn by patients with high BMI.
Will not be analysed formally.
Time frame: 1 hour
Exploratory: To measure RespiraSense device alarm generation and assess the rationale behind these to determine if false alarms and therefore alarm fatigue is occurring
Will not be analysed formally.
Time frame: 1 hour
Plan to share: No
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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