Health TrialsbyHealthPanel

Controlled Oxygen Desaturation Study of the Neonatal Wireless Transmission System

ConditionsTesting AccuracyDevice Performance
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorKathryn Beardsall

About this trial

This study aims to test the oxygen saturation component of the newly developed NeWTS monitoring system and compare readings from NeWTS to a traditional wired clinical monitor. It is important the investigators do this study in healthy adults as part of the development of this system, to make sure the oxygen saturation readings are accurate and before NeWTS is used in Neonatal Intensive Care (NICU).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Be aged 18-55 years

Willing and have capacity to provide written informed consent

Healthy adult volunteers classified as ASA 1

Non-smoker (this does not exclude vaping)

Disqualifiers

History of Bleomycin treatment at any time

Smokers or individuals exposed to high levels of carbon monoxide

Compromised circulation, injury, or physical malfunction of the sensor sites which would limit the ability to test sites needed for the study

Morbidly obese (defined as BMI >39.5) or significantly underweight (BMI <18)

Trial design

Design model

Single group

Treatments tested in this trial

  • Neonatal Wireless Transmission System

    Device

    The primary objective for this clinical investigation is to validate the SpO2 performance of the NeWTS in comparison to "gold-standard" measurements of blood SaO2 by a calibrated and QC'ed ABL90 Flex plus blood gas analyser.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Controlled Oxygen Desaturation of Healthy Adult VolunteersOther 1 intervention

Trial outcomes

Primary outcomes

1

Validation of SpO2 performance

Validation of the SpO2 performance of the NeWTS in comparison to "gold standard" measurements of blood SaO2 by a calibrated and QC'ed ABL90 Flex plus blood gas analyser.

Time frame
From enrolment to end of study 3-4 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kathryn Beardsall

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust

Sponsor institution

National Institute for Health Research, United Kingdom

Collaborator

University of Cambridge

Collaborator

University Hospital Birmingham NHS Foundation Trust

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: