Evaluation of ExSpiron™ Measurements Derived Without Patient Specific Calibration

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

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-01

Study Completion Date

2016-04-30

Brief Summary

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

Previous studies have shown that the ExSpiron™ can provide non-invasive, real-time, accurate measurements of minute ventilation (MV), tidal volume (TV) and respiratory rate (RR) after calibration with a spirometer. The purpose of this study is to compare the MV, TV and RR values measured by the ExSpiron™ without prior spirometer calibration to values obtained with a spirometer calibration. In this study, the MV and TV values will be compared between the ExSpiron™ with and without prior patient-specific calibration of the ExSpiron™ to a spirometer

Related Clinical Trials

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

Evaluation of Non-Invasive Respiratory Volume Monitor

NCT03039881

Monitoring for Low Minute Ventilation Post Surgery

COMPLETED

Respiratory Volume Measure Using ExSpiron 1Xi

NCT02998294

ICU(Intensive Care Unit) Patients Mechanical Ventilation After Surgery

COMPLETED NA

Detection of Postoperative Respiratory Depression in High Risk Patients Utilizing Minute Ventilation Monitoring

NCT04017702

Respiratory Depression

COMPLETED

Intrinsic Respiratory Rate Assessment During Mechanical Ventilation to Accelerate Spontaneous Breathing and Extubation

NCT06445049

Reverse Triggering Patient Ventilator Dyssynchrony

NOT_YET_RECRUITING NA

Study of Neural Inspiratory Time and Expiratory Delay in Patient and Health During Spontaneous Breathing and Ventilation

NCT02817035

State Key Laboratory of Respiratory Disease

COMPLETED NA

Detailed Description

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

In order to evaluate the performance of the device under the range of conditions encountered in the clinical environment, the respiratory volume monitor (RVM) was tested throughout a range of respiratory rates and also during erratic breathing patterns. At 4 and 36 breaths per minute (the extremes of the rates anticipated to be encountered in the clinical setting), and during erratic breathing, RVM and spirometry measurements were found to be highly-correlated (r=0.98 ±0.01 (mean ±95%CI) at 4 breaths/min, 0.97 ±0.01 at 36, and 0.93 ±0.04 during erratic breathing). These studies also included calibration of the ExSpiron to the spirometer.

The primary objective of the study is to compare the minute ventilation (MV), tidal volume (TV) and respiratory rate (RR) measurements collected and reported by the ExSpiron, without prior ExSpiron calibration, against acquired MV, TV, and RR measurements from an ExSpiron with prior individual specific calibration to a spirometer using either a Wright Spirometer or a Morgan Flow Volume Loop (FVL) Pneumotachograph Spirometer. A secondary objective will be to confirm the PadSet functionality after 24 hours of wear in accordance with current labeling.

Conditions

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

Non-Invasive Respiratory Volume Monitoring

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.

ExSpiron

Non-Invasive respiratory volume monitoring

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

RVM

Eligibility Criteria

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

Inclusion Criteria

* Males and Females aged 21-90
* Able to provide written informed consent
* Able to participate in a two day study

Exclusion Criteria

* Men and Women aged \<21 years and \>90 years of age
* Inability to follow study and/or study staff instructions
* Inability to perform study procedures, e.g. spirometry
* Allergy to the electrodes or components of the electrodes

Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes