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Oxygen Reserve Index (ORi) Expanded Data Set Validation of INVSENSOR00029

22 septembre 2022 mis à jour par: Masimo Corporation
ORi is a unitless index that could help clinicians with their assessments of normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00. An ORi of 0.00 corresponds to PaO2 values of 100mmHg and below, and an ORi of 1.00 corresponds to PaO2 values of 200mmHg and above. In this study, the PaO2 is varied by controlling the concentration of oxygen the study volunteer breathes. Changes in ORi values are analyzed by comparing it to corresponding changes in PaO2 measurements from blood samples.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

29

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • California
      • Irvine, California, États-Unis, 92618
        • Masimo Corporation

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 50 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Subject weighs a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet tall.
  • Hemoglobin value is greater than or equal to 11 g/dL.
  • Baseline heart rate ≥ 45 bpm and ≤ 85 bpm.
  • Carbon monoxide (CO) value ≤ 2.0% fractional carboxyhemoglobin (FCOHb).
  • Subject has a physical status of ASA I or II (American Society of Anesthesiology Class 1; Healthy subjects without any systemic disease at all. American Society of Anesthesiology Class II; subjects with mild systemic disease) as it applies to the systemic disease portion of the classification.
  • Blood Pressure: (Systolic Blood Pressure ≤ 140 mmHg and ≥ 90 mmHg, Diastolic Blood Pressure ≤ 90 mmHg and ≥ 50 mmHg), and if blood pressure is lower than 100/60 subject passes an orthostatic blood pressure test
  • Subject is able to read and communicate in English and understands the study and risks involved.

Exclusion Criteria:

  • Subject is pregnant.
  • Subject has a BMI > 35 and has been classified as morbidly obese or at an increased risk for participation by a medical professional.
  • Subject has a history of fainting (vasovagal), blacking out or losing consciousness during or after a blood draw, or has a fear of blood draws.
  • Subject smokes one pack of cigarettes or more in one week, and/or the equivalent of e-cigarette liquid, and smokers are not being recruited as indicated in the CSRF.
  • Subject has open wounds, inflamed tattoos or piercings and/or any visible healing wounds that a medical professional renders them at an increased risk for participation (per physician discretion).
  • Subject has known drug or alcohol abuse or uses recreational drugs.
  • Subject experiences frequent or severe headaches and/or migraine headaches, migraine auras, altitude sickness, and/or headaches accompanied by visual changes or sensitivity to light or sound.
  • Subject has experienced a concussion or head injury with loss of consciousness within the past 12 months.
  • Subject has any history of a stroke, myocardial infarction, seizures or heart attack.
  • Subject who has taken anticoagulant medications within the last 30 days (excluding nonsteroidal anti-inflammatory drugs (NSAIDS).
  • Subject has donated blood within the past 4 weeks.
  • Subject has any chronic bleeding disorder (i.e. hemophilia)
  • Subject has any symptomatic cardiac dysrhythmia (i.e. atrial fibrillation) and has not received clearance from their physician to participate.
  • Subject has Wolff-Parkinson-White Syndrome or Stokes - Adams syndrome.
  • Subject has known neurological and/or psychiatric disorder (i.e. schizophrenia, bipolar disorder, Multiple Sclerosis, Huntington's disease) that interferes with the subjects' level of consciousness.
  • Subject has taken opioid pain medication within 24 hours of start of study.
  • Subject has any type of infectious disease (i.e. Hepatitis, HIV, Tuberculosis, Flu, Malaria, Measles, etc.).
  • Subject is taking medications known to treat any type of infectious disease (per physician discretion).
  • Subject has either signs or history of peripheral ischemia or carpal tunnel syndrome.
  • Subject has had invasive surgery within the past year- including but not limited to major dental surgery, appendix, plastic surgery (per physician discretion).
  • Subject has had invasive surgery within the past year- including but not limited to gallbladder, major fracture repairs (involving plates/ screws), jaw surgery, urinary tract surgery, major ENT surgery, joint replacement or gynecological surgeries, heart surgery or thoracic surgery.
  • Subject has symptoms of congestion, head cold, flu or other illnesses.
  • Subject is claustrophobic and/or has generalized anxiety disorder.
  • Subject has been in severe car accident(s) or a similar type of accident(s) requiring hospitalization within the past 12 months.
  • Subject has any cancer or history of cancer (not including skin cancer), per physician discretion.
  • Subject has chronic unresolved asthma, lung disease (including COPD) and/or respiratory disease.
  • Subject is allergic to lidocaine, latex, adhesives, or plastic.
  • Subject has a heart condition, insulin-dependent Diabetes, or uncontrolled hypertension.
  • Subject has delivered vaginally, has had a pregnancy terminated, a miscarriage with hospitalization, or had a C-section within the past 6 months.
  • Subject intends to participate in any heavy lifting, repetitive movement of their wrist (including riding a motorcycle, tennis) or exercise (working out, riding a bike, riding a skate board etc.), or any activity that will put additional stress on the wrist within 24 hours following a study that involved an arterial line.
  • Subject has any medical condition which in the judgement of the investigator and/or medical staff, renders them ineligible for participation in this study (Discretion of investigator/study staff).

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

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
Expérimental: INVSENSOR00029
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00029 sensor
Noninvasive pulse oximeter sensor

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Sensibilité aux modifications des valeurs ORi par rapport aux modifications correspondantes des valeurs PaO2.
Délai: 1 à 5 heures par sujet
ORi est une valeur d'indice sans unité et ORi ne mesure pas directement la PaO2. Par conséquent, la sensibilité, la spécificité et la concordance sont calculées pour évaluer les changements d'ORi par rapport aux changements de PaO2.
1 à 5 heures par sujet
Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values
Délai: 1-5 hours per subject
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore, sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2.
1-5 hours per subject
Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
Délai: 1 to 5 hours per subject
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore, sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2.
1 to 5 hours per subject

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

20 août 2019

Achèvement primaire (Réel)

28 août 2019

Achèvement de l'étude (Réel)

28 août 2019

Dates d'inscription aux études

Première soumission

3 septembre 2019

Première soumission répondant aux critères de contrôle qualité

3 septembre 2019

Première publication (Réel)

6 septembre 2019

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

19 octobre 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 septembre 2022

Dernière vérification

1 septembre 2022

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • TP-20088

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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