- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05139693
Accuracy of Pulse Oximeters With Profound Hypoxia
Studieöversikt
Detaljerad beskrivning
The study will include at least 10 subjects (up to 14 if needed to reach the 200 necessary data points to meet the ISO 80601-2-61:2017).
Per FDA guidance, at least 2, or 15% of the subjects will have dark skin.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
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California
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San Francisco, California, Förenta staterna, 94143
- Hypoxia Research Laboratory
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
The study will include at least 10 subjects (up to 14 if needed to reach the 200 necessary data points to meet the ISO 80601-2-61:2017).
Per FDA guidance, at least 2, or 15% of the subjects will have dark skin
Beskrivning
Inclusion Criteria:
- The subject is male or female, aged ≥18 and <50.
- The subject is in good general health with no evidence of any medical problems.
- The subject is fluent in both written and spoken English.
- The subject has provided informed consent and is willing to comply with the study procedures.
Exclusion Criteria:
- The subject is obese (BMI>30).
- The subject has a known history of heart disease, lung disease, kidney or liver disease.
- Diagnosis of asthma, sleep apnea, or use of CPAP.
- Subject has diabetes.
- Subject has a clotting disorder.
- The subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
- The subject has any other serious systemic illness.
- The subject is a current smoker.
- Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
- The subject has a history of fainting or vasovagal response.
- The subject has a history of sensitivity to local anesthesia.
- The subject has a diagnosis of Raynaud's disease.
- The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
- The subject is pregnant, lactating or trying to get pregnant.
- The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
- The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Retrospektiv
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
To obtain a reading from the Respiree device that corresponds to the associated blood sample or a reference oximeter.
Tidsram: 1 hour per subject
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The number of subjects and the number of comparisons (paired pulse oximeter readings and arterial saturation values) is determined by current FDA guidance requirements.
This is a minimum of 200 data points and 10 subjects.
In the course of this type of study, some subjects may drop out, some readings can be lost due to motion or other interference and occasionally some do not consent.
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1 hour per subject
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 10-00437
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
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