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Testing the effects of low levels of blood oxygen and movement of the accuracy of portable vital signs monitors

Virtual HDU: hypoxia study. Accuracy and validity testing of ambulatory monitoring system

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN61535692
Enrollment
30
Registered
2019-06-10
Start date
2019-06-18
Completion date
Unknown
Last updated
2023-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vital sign monitoring Not Applicable

Interventions

Participants will visit the designated research facility for the study visit. On arrival, participants will be assessed for their suitability for the study. An arterial line will be inserted into thei

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Willing and able to give informed consent for participation in the study 2. Men and women aged 18 or over and in generally good health

Exclusion criteria

Exclusion criteria: 1. Allergies to adhesive dressings (such as bio-occlusive dressings or micropore) or local anesthesic (e.g. Lidocaine) 2. Intra-cardiac device (e.g. Permanent pacemaker) or previous wrist arterial line 3. Epilepsy 4. Angina, congenital heart disease or history of severe cardiopulmonary disease 5. History of anaemia (reported in the pre-screening telephone call) or Hb below 100 g/l on first test 6. Resting hypoxaemia (SpO2 <94%) or significant cardiopulmonary disease rendering exposure to alveolar hypoxia unsafe, as determined by the research physician 7. Pregnancy or breastfeeding 8. Clotting disorders and use of antiplatelet or anticoagulant medication (such as Aspirin) 9. Claustrophobia precluding spell in the hypoxic exposure

Design outcomes

Primary

MeasureTime frame
Specificity and sensitivity of currently available ambulatory vital-sign monitors will be assessed by comparing continuous oxygen saturation, pulse rate and breathing rate data from each ambulatory monitor with arterial blood oxygen saturation measured through blood gas analysis, respiratory rate derived from capnography and pulse rate derived from ‘usual care’ hospital grade pulse oximetry monitoring. Arterial oxygen saturation will be measured at incremental drops in SpO2, up to 80%. Respiratory rate and pulse rate will be measured continuously throughout testing.

Secondary

MeasureTime frame
The effects of movement on data acquisition by currently available ambulatory vital-sign monitors will be assessed by comparing continuous oxygen saturation, pulse rate and breathing rate data from each ambulatory monitor with arterial blood oxygen saturation measured through blood gas analysis, respiratory rate derived from capnography and pulse rate derived from ‘usual care’ hospital grade pulse oximetry monitoring. Arterial oxygen saturation will be measured after each movement is completed. Respiratory rate and pulse rate will be measured continuously throughout testing.

Countries

England, United Kingdom

Contacts

Public ContactSarah Vollam
Sarah.vollam@ndcn.ox.ac.uk+44 (0)1865231440

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 19, 2026