Sensor Validation Study - Quality Assurance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-28

Study Completion Date

2018-09-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Respiration Rate V2.0 in Healthy Volunteers

NCT01804062

Focus of the Study is Measuring Respiratory Rate

COMPLETED

Respiratory Rate Validation Study - RS001.2 Respiree Cardio-Respiratory Monitor

NCT05210712

A Minimum of 30 Adults, Ages 18 Years and Older

COMPLETED

Respiration Rate V2.0 in a Hospital Setting

NCT01837537

Respiratory Rate

COMPLETED

Methods for the Measurement of Respiratory Rate

NCT02672007

Respiratory Rate Measurement Methods.

COMPLETED NA

Validation of Respiration Rate Algorithms

NCT01472133

Respiratory Rate Pulse Oximetry

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Rate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No