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NCT03565679 · ClinicalTrials.gov registry record · NA

SpO2 Accuracy Comparison of Medline ReNewal Sensors to Arterial Blood CO-Oximetry

A NA study of Healthy and Arterial Oxygen Saturation, sponsored by Medline Industries.

Completed
Registry status
NA
Development phase
10
Enrollment target
1
Study location

NCT03565679: Completed NA study of Healthy and Arterial Oxygen Saturation, sponsored by Medline Industries.

NCT03565679 is a NA study of Healthy and Arterial Oxygen Saturation that has completed, run by Medline Industries. The registered enrollment target is 10 participants, below the 647-participant average among 1,090 other Healthy 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

NCT03565679, a NA study of Healthy and Arterial Oxygen Saturation, has completed, sponsored by Medline Industries.

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

Study Summary

The purpose of this clinical study is to validate the SpO2 accuracy of the Medline ReNewal pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the ReNewal sensors. It is required that the Accuracy Root Mean Square (ARMS) performance of the ReNewal pulse oximetry sensors will meet a specification of 3 or better in non-motion conditions for the range of 70 - 100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification.

Primary Outcome

Percentage of SpO2 (oxygen saturation by pulse oximetry) measured by the Reprocessed Oximeter pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The Accuracy root mean square (ARMS) between measured SpO2 and reference SaO2 (arterial oxygen saturation) must meett the 3% specification for each Medline Renewal Reprocessed pulse oximetry sensor style.

Interventions

  • DEVICE MEDLINE RENEWAL PULSE OXIMETRY SENSORS
  • DEVICE CO-OXIMETRY SENSORS

Study Locations (1)

Colorado

  • Clinimark Desaturation Laboratory, Site ID# 001 - Louisville

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2018-05-09
Est. Completion 2018-05-10
Phase NA
Medline Industries

24 total trials

What the finished NCT03565679 record still lists

NCT03565679 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower).

The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which MEDLINE RENEWAL PULSE OXIMETRY SENSORS is the first listed.

NCT03565679 reports a single indexed study location in Colorado.

Frequently Asked Questions

What is clinical trial NCT03565679 about?

NCT03565679 is a clinical study titled "SpO2 Accuracy Comparison of Medline ReNewal Sensors to Arterial Blood CO-Oximetry". The purpose of this clinical study is to validate the SpO2 accuracy of the Medline ReNewal pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO...

What is the current status of trial NCT03565679?

This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2018-05-09. Estimated completion is 2018-05-10.

What conditions does trial NCT03565679 study?

This clinical trial studies the following conditions: Healthy, Arterial Oxygen Saturation.

What interventions are being tested in trial NCT03565679?

The interventions under investigation include: MEDLINE RENEWAL PULSE OXIMETRY SENSORS (DEVICE), CO-OXIMETRY SENSORS (DEVICE).

Who is sponsoring clinical trial NCT03565679?

This trial is sponsored by Medline Industries, which has 24 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03565679 being conducted?

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

Similar trials for Healthy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03565679's enrollment target sits among peer trials

10 1035th of 1090 higher than 35 of 1,090 other Healthy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy 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 NCT03565679, the US trial registry maintained by the National Library of Medicine. NCT03565679 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.