NCT05250102

Brief Summary

To validate the SpO2 accuracy, bias, and precision of Medline's reprocessed pulse oximetry sensors as compared to SaO2 in arterial blood samples as assessed by CO-oximetry in neonates.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

June 13, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 30, 2024

Completed
Last Updated

October 30, 2024

Status Verified

October 1, 2024

Enrollment Period

1.3 years

First QC Date

February 10, 2022

Results QC Date

October 2, 2024

Last Update Submit

October 29, 2024

Conditions

Premature Birth

Outcome Measures

Primary Outcomes (1)

  • Bland-Altman Analysis for Nellcor Pulse Oximeter

    BIAS Measurement and 95% confidence interval calculated using a Bland-Altman plot (mean vs. difference of SaO2 and SpO2) and an error plot (SaO2 vs. difference of SaO2 and SpO2) were generated. The B\&A plot analysis is a simple way to evaluate a bias between the mean differences, and to estimate an agreement interval, within which 95% of the differences of the second method, compared to the first one, fall. Data can be analyzed both as unit differences plot and as percentage differences plot. We ran a percentage mean difference plot.

    15 episodic minutes

Study Arms (1)

Pulse oximeter sensor readings

OTHER

Subjects who satisfy all of the inclusion criteria will be eligible to participate in the study, will receive intervention (the Masimo and Nellcor sensors, and their arterial blood sample will be taken in the normal course of care). This is a single arm study. Those who don't meet the inclusion/ exclusion criteria won't be eligible to participate.

Device: Pulse oximeter sensors

Interventions

Pulse oximeter sensorsDEVICE

Pulse oximeter reading will be compared to CO-oximeter reading.

Pulse oximeter sensor readings

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Subjects who are postnatal 28 days or younger (neonates)
  • Subjects who are likely to receive one or more ABG measurements as part of their clinical SOC
  • Subjects who weigh less than 5 Kg (weight range for thesensors)

You may not qualify if:

  • Subjects with current signs and symptoms of a clinically significant Patent Ductus Arteriosus (PDA) combined with a current or planned arterial line placement which will affect the validity of the co-oximetry measurement
  • Subjects with physical malformation of hands, fingers, feet, or toes that would limit the ability to place sensors for this study
  • Subjects judged by the Principal Investigator (PI) to be inappropriate for participation in this study
  • Subjects for whom placing a pulse oximeter will cause dermatological issues (e.g. allergic to foam rubber or adhesive tape)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Eastern Carolina University

Greenville, North Carolina, 27858, United States

Location

Related Publications (3)

  • Ascha M, Bhattacharyya A, Ramos JA, Tonelli AR. Pulse Oximetry and Arterial Oxygen Saturation during Cardiopulmonary Exercise Testing. Med Sci Sports Exerc. 2018 Oct;50(10):1992-1997. doi: 10.1249/MSS.0000000000001658.

    PMID: 29771822BACKGROUND

  • Dawson JA, Davis PG, O'Donnell CP, Kamlin CO, Morley CJ. Pulse oximetry for monitoring infants in the delivery room: a review. Arch Dis Child Fetal Neonatal Ed. 2007 Jan;92(1):F4-7. doi: 10.1136/adc.2006.102749. No abstract available.

    PMID: 17185428BACKGROUND

  • Bland JM, Altman DG. Agreement between methods of measurement with multiple observations per individual. J Biopharm Stat. 2007;17(4):571-82. doi: 10.1080/10543400701329422.

    PMID: 17613642BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Results Point of Contact

Title
Julie J. Finley
Organization
Medline Industries, LP
jjfinley@medline.com
(800) 633-5463

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2022

First Posted

February 22, 2022

Study Start

June 13, 2022

Primary Completion

October 10, 2023

Study Completion

October 10, 2023

Last Updated

October 30, 2024

Results First Posted

October 30, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)