Controlled Oxygen Desaturation Study of the Neonatal Wireless Transmission System (NeWTS-DS)
Controlled Oxygen Desaturation Study of the Neonatal Wireless Transmission System (NeWTS): NeWTS-DS
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The aim of the controlled desaturation study is to show that the NeWTS device can safely measure blood oxygen content in comparison to the "gold-standard" method of measuring blood oxygen levels (SaO2). To assess this, blood oxygen levels will be measured while the amount of oxygen participants breathe is gradually reduced.
Healthy adults will start breathing oxygen at the same levels as in room air (21% oxygen) and this will be gradually reduced. The measurements from the NeWTS device will be compared to the value taken directly from the blood via an arterial line (SaO2). The SaO2 is measured by obtaining multiple blood samples from an artery in the body.
As described in EN ISO 80601-2-61:2026 a minimum of 24 participants will be recruited with an average of 20 (±4), range 16-30 data points per participant.
The investigators will include a distribution of data pairs, with total pairs split across each desaturation decade between 70 % to 100 % saturations, with approximately 33 %, but no less than 25 %, in each decade.
90 % or greater of participants shall provide at least one useable data pair with an SaO2 below 85 %.
At least 75 % of participants shall also have provided at least one useable data pair with an SaO2 between 70 % to 80 %.
The number of data pairs for a given SaO2 decile (i.e. 70 % to 80 %, 80 % to 90 % and 90 % to 100 %) will be derived approximately equally from participants across skin pigment categories, ensuring that >25 % of data points come from light, medium and dark participants by MST and ITA.
Type d'étude
Inscription (Estimé)
Phase
- Première phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Kathryn Beardsall, MD
- Numéro de téléphone: +447565 964631
- E-mail: kb274@cam.ac.uk
Sauvegarde des contacts de l'étude
- Nom: Catherine Guy, BSc(Hons)
- E-mail: cc570@cam.ac.uk
Lieux d'étude
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England
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Birmingham, England, Royaume-Uni, B15 2GW
- Clinical Research Facility
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Contact:
- Conor Jones, MSc
- Numéro de téléphone: +447443264198
- E-mail: newts.hrcddr@uhb.nhs.uk
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Autre: Controlled Oxygen Desaturation of Healthy Adult Volunteers
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Validation of SpO2 performance
Délai: From enrolment to end of study 3-4 hours
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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.
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From enrolment to end of study 3-4 hours
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Kathryn Beardsall, MD, University of Cambridge
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- A097812
- NIHR206500 (Autre subvention/numéro de financement: NIHR)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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