NCT06994663

Brief Summary

Pulse oximetry is a well-established, non-invasive measurement tool used to estimate arterial oxygen saturation. The accuracy of these cheap, readily available finger pulse oximeters has not been robustly assessed in a clinical trial however. It is vital for clinical practice that this technology is reliable in tracking changes in oxygen saturations at times of ill health as varying physiological parameters may, in theory, contribute to inaccurate readings. This study will investigate whether these new devices provide a sufficiently accurate measurement of oxygen levels in the blood (when compared to arterial blood gas sampling) to endorse their use in routine hospital practice.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2015

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2018

Completed
7.4 years until next milestone

First Posted

Study publicly available on registry

May 29, 2025

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

January 17, 2018

Last Update Submit

May 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlation

    The handheld pulse oximeters will exhibit a good correlation as evidenced by the Intraclass correlation coefficient of 0.75. The cohort patients who were deemed by their treating physician to require an arterial blood gas sample had simultaneous SpO2 readings using 3 pulse oximeters (TempIR-Oxy, Jumper JPD-500A and Nonin Vantage 9590). Data were analysed using Pearson correlation co-efficient (r) and Bland Altman bias plot.

    Baseline

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In hospital patients requiring blood gas sampling (Typically this would represent patients who are complaining of breathlessness or who have low oxygen saturations)

You may qualify if:

  • Hospital inpatients deemed by the clinical team to require arterial blood gas sampling (Typically this would represent patients who are complaining of breathlessness or who have low oxygen saturations)
  • Informed consent

You may not qualify if:

  • Inability to consent (including language barrier)
  • Age \<16 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2018

First Posted

May 29, 2025

Study Start

December 7, 2015

Primary Completion

October 31, 2016

Study Completion

October 31, 2016

Last Updated

May 29, 2025

Record last verified: 2025-05