ClinicalTrials.gov
ClinicalTrials.gov Menu

Sensor Validation Study - Quality Assurance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03306537
Recruitment Status : Active, not recruiting
First Posted : October 11, 2017
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
PMD Solutions

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


Condition or disease Intervention/treatment
Respiratory Rate Device: RespiraSense Respiratory Rate Monitor

Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Quality Assurance Study of Respiratory Rate Measurements on Obese Patients With a Novel Monitoring Technology
Actual Study Start Date : July 28, 2017
Actual Primary Completion Date : August 7, 2018
Estimated Study Completion Date : September 7, 2018

Intervention Details:
  • Device: RespiraSense 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


Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Obese patients with a BMI ≥35
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03306537


Locations
United Kingdom
Queen Alexandra Hospital
Portsmouth, United Kingdom, PO6 3LY
Sponsors and Collaborators
PMD Solutions
Investigators
Principal Investigator: Lorraine Albon Portsmouth Hospitals NHS Trust

Responsible Party: PMD Solutions
ClinicalTrials.gov Identifier: NCT03306537     History of Changes
Other Study ID Numbers: PMD-CS-011
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No