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NCT01494844 · ClinicalTrials.gov registry record · Early Phase 1

Comfort Evaluation of Non-Invasive Respiratory Monitor Interfaces

A Early Phase 1 study, sponsored by University of Alabama at Birmingham.

Completed
Registry status
Early Phase 1
Development phase
30
Enrollment target

NCT01494844: Completed Early Phase 1 study, sponsored by University of Alabama at Birmingham.

NCT01494844 is a Early Phase 1 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 30 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01494844, a Early Phase 1 study, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
Early Phase 1
Development phase
30 participants
Enrollment target

Study Summary

This research study will test the comfort of two noninvasive respiratory monitoring sensors (the connection to a monitor worn by a person-not the monitor). The two sensors, Masimo Rainbow Acoustic Monitoring sensor and Oridion Smart Capnoline Plus H sensor, are cleared by the U.S. Food and Drug Administration (FDA) and currently used in the clinical setting. People who enter into the study will wear the two interfaces, one after the other, for 20 minutes each (10 minutes with a small flow of air to the nostrils and 10 minutes without) and rate the comfort of each with a seven question survey. A total of 30 participants will be recruited.

Primary Outcome

A seven-question written instrument constructed in the style of descriptive analogue to evaluate multiple facets of device comfort. Answer choices allow either ordinal ranking (one requires a ranking on a continuous time scale).

Interventions

  • DEVICE Respiratory monitor patient interface.

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2011-06
Est. Completion 2011-09
Phase Early Phase 1
University of Alabama at Birmingham

1,160 total trials

What the finished NCT01494844 record still lists

NCT01494844 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower).

The record links to 0 conditions, and to 1 intervention - of which Respiratory monitor patient interface. is the first listed.

NCT01494844 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01494844 about?

NCT01494844 is a clinical study titled "Comfort Evaluation of Non-Invasive Respiratory Monitor Interfaces". This research study will test the comfort of two noninvasive respiratory monitoring sensors (the connection to a monitor worn by a person-not the monitor). The two sensors, Masimo Rainbow Acoustic Monitoring sensor and Oridion Smart Capnoline Plus H sensor, are cleared by the U.S. Food and Drug Admi...

What is the current status of trial NCT01494844?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2011-06. Estimated completion is 2011-09.

What interventions are being tested in trial NCT01494844?

The interventions under investigation include: Respiratory monitor patient interface. (DEVICE).

Who is sponsoring clinical trial NCT01494844?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01494844's enrollment target sits among peer trials

30 807th of 2000 higher than 1,075 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 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 NCT01494844, the US trial registry maintained by the National Library of Medicine. NCT01494844 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.