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NCT06521385 · ClinicalTrials.gov registry record · NA

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

A NA study of Respiratory Monitoring, sponsored by Makani Science.

Completed
Registry status
NA
Development phase
32
Enrollment target
1
Study location

NCT06521385: Completed NA study of Respiratory Monitoring, sponsored by Makani Science.

NCT06521385 is a NA study of Respiratory Monitoring that has completed, run by Makani Science. The registered enrollment target is 32 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06521385, a NA study of Respiratory Monitoring, has completed, sponsored by Makani Science.

COMPLETED
Registry status
NA
Development phase
32 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

Mean absolute error (MAE) was calculated for concurrent respiratory rate measurements obtained from the Makani Science system (experimental device) and capnography (reference device). MAE was defined as the average of the absolute differences between the experimental and reference measurements. The lower and upper bounds of the 95% confidence interval were also calculated for each MAE. Device performance was considered acceptable if the MAE was within 3 breaths per minute (BPM) of the reference

Conditions Studied

Interventions

  • DEVICE Makani Science Respiratory Monitoring System

Study Locations (1)

California

  • Illumination Foundation - Fullerton

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2024-05-17
Est. Completion 2024-07-02
Phase NA
Makani Science

1 total trials

What the finished NCT06521385 record still lists

NCT06521385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 1 condition, with Respiratory Monitoring appearing as the primary indexed condition, and to 1 intervention - of which Makani Science Respiratory Monitoring System is the first listed.

NCT06521385 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT06521385 about?

NCT06521385 is a clinical study titled "Comparison of Non-invasive Respiratory Monitoring System (RMS) to Capnography for Respiratory Rate (RR)". 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.

What is the current status of trial NCT06521385?

This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2024-05-17. Estimated completion is 2024-07-02.

What conditions does trial NCT06521385 study?

This clinical trial studies the following conditions: Respiratory Monitoring.

What interventions are being tested in trial NCT06521385?

The interventions under investigation include: Makani Science Respiratory Monitoring System (DEVICE).

Who is sponsoring clinical trial NCT06521385?

This trial is sponsored by Makani Science, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06521385 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT06521385's enrollment target sits among peer trials

32 1578th of 2000 higher than 409 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06521385, the US trial registry maintained by the National Library of Medicine. NCT06521385 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.