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Controlled Oxygen Desaturation Study of the Neonatal Wireless Transmission System

Not Yet RecruitingEARLY_Phase 1

Sponsor: Kathryn Beardsall

Conditions: Testing Accuracy, Device Performance

Interventions: Neonatal Wireless Transmission System

Countries: United Kingdom

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 overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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)
  * Willing and able to comply with study procedures and duration

Exclusion Criteria:

* 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)
* Pregnancy
* Participants who can conceive a pregnancy or carry a child (including women, trans men and non-binary people) will be required to demonstrate a negative pregnancy test
* Unwillingness or inability to remove coloured nail polish or nail attachments from test digits (relevant for reference pulse oximeter) or to have medical monitoring attached
* Known health conditions or medications disclosed on Health Assessment Form which mean that participant is not healthy
* Allergy to lidocaine
* Known allergy to adhesives used in medical dressings or tapes or materials used to adhere NeWTS components.
* Enrolment in any other clinical investigation/trial that is deemed would compromise the validity of the data or safety of the patient (at the discretion of the local PI)
* Sunburn/spray tan or other pigments on hands

Locations (1)

Birmingham, England, United Kingdom