Comparison of Non-invasive Respiratory Monitoring System (RMS) to Capnography for Respiratory Rate (RR)

NCT ID: NCT06521385

Last Updated: 2024-07-26

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-17

Study Completion Date

2024-07-02

Brief Summary

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The goal of this clinical trial is to compare the performance of a novel non-invasive respiratory monitoring system against the gold standard methods (capnography) in human subjects. The main question it aims to answer is whether the novel monitoring system comparable to the current standards.

Detailed Description

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Conditions

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Respiratory Monitoring

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Device Arm

Subjects with both the reference and experimental device placed for paired data collection

Group Type EXPERIMENTAL

Makani Science Respiratory Monitoring System

Intervention Type DEVICE

Subjects monitored by the Makani Science Respiratory Monitoring System

Interventions

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Makani Science Respiratory Monitoring System

Subjects monitored by the Makani Science Respiratory Monitoring System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Between age of 22-99
* BMI between 15 and 40 kg/m\^2

Exclusion Criteria

* Medical history of serious symptomatic, cardiac, or pulmonary disease.
* History of serious skin irritation (severe rash or blisters) caused by medical adhesives (tape).
* Cannot lay still for one (1) hour.
* Cannot give written informed consent.
* Unable to follow instructions.
Minimum Eligible Age

22 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Makani Science

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Illumination Foundation

Fullerton, California, United States

Site Status

Countries

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United States

Other Identifiers

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Makani-004

Identifier Type: -

Identifier Source: org_study_id

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