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Completed

NCT Number: NCT03306537

Sensor Validation Study - Quality Assurance

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

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Key information

Conditions

Respiratory Rate

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen Alexandra Hospital

Portsmouth, PO6 3LY, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RespiraSense Respiratory Rate Monitor

Device

RespiraSense device will be attached at the same time as the capnograph (gold standard) and both will measure simultaneously for one hour

Primary outcomes

  1. Comparison of PMD RespiraSense against capnography in obese patients.

    Time frame: 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 outcomes

  1. Comparison of PMD RespiraSense in obese patients with BMI below 50 and those with BMI of 50 or above.

    Time frame: 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.

  2. Identification of any accuracy spread patterns as BMI increases.

    Time frame: 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.

  3. Collection of feedback on device comfort when worn by patients with high BMI.

    Time frame: 1 hour

    Will not be analysed formally.

Other outcomes

  1. Exploratory: To measure RespiraSense device alarm generation and assess the rationale behind these to determine if false alarms and therefore alarm fatigue is occurring

    Time frame: 1 hour

    Will not be analysed formally.

Sponsors and collaborators

Lead sponsor

PMD Solutions

Industry

Registry information

Official study title

A Quality Assurance Study of Respiratory Rate Measurements on Obese Patients With a Novel Monitoring Technology

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 11, 2017
Registry last updated
Mar 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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