Healthy Volunteer Study to Evaluate the Impact of Various Common Interventions on Venous Pressure Signal Captured by PIVA
29 mars 2021 mis à jour par: Baxter Healthcare Corporation
Healthy Volunteer Study to Evaluate the Impact of Various Common Interventions on Venous Pressure Signal Captured by Peripheral Intravenous Analysis (PIVA) Technology
Non-invasive sensors have been used in research in the United States (US) to aid in the assessment of a subject's heart rate (HR), respiratory rate (RR) and fluid volume status. This estimate and its trended value over time, when used along with clinical signs and symptoms and other subject test results, can aid in the process of reaching a diagnosis and formulating a therapeutic plan when abnormalities of volume status, or RR are suspected.
Non-invasive sensors like the Peripheral IntraVenous Analysis (PIVA) sensor under development by Baxter and the Deltran blood pressure (BP) transducer, capture waveforms created by physiological mechanisms such as blood flow and breathing. An algorithm is then applied to the captured waveform to give clinicians an idea of hemodynamic (volume) status, and RR.
In this study, the functional robustness (e.g., subjects sitting, elevated leg positions, etc.) of the PIVA algorithm/technology will be demonstrated by evaluating the impact of various common interventions on the venous pressure signal. All subjects will undergo 33 interventions expected to take approximately 4 - 6 hours.
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
26
Phase
- N'est pas applicable
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
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Florida
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Miami, Florida, États-Unis, 33126
- Baxter Investigational Site
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-
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 55 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Has reviewed, understood and signed an informed consent.
- Age between 18-55 years.
- Body mass index between 18.5-35 kg/m2 with a minimum weight of 45 kg.
- Willing and able to comply with study procedures and duration.
- Subjects wearing any type of nail polish and/or acrylic nails must be willing to remove them prior to admission.
Exclusion Criteria:
- Female subjects who are pregnant.
- Subjects who are currently participating in, or have within the past 30 days participated in, another interventional clinical study or have used an investigational device or drug within the past 30 days.
Subjects with known respiratory conditions including but not limited to:
- uncontrolled / severe asthma
- flu / influenza
- pneumonia / bronchitis
- shortness of breath / respiratory distress
- respiratory or lung surgery
- emphysema, chronic obstructive pulmonary disease, lung disease
- any other health condition that the Principal Investigator thinks can affect respiratory health
Subjects with self-reported heart or cardiovascular conditions including but not limited to:
- hypertension
- history of cardiovascular surgery
- chest pain (angina)
- heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia
- previous heart attack
- blocked artery
- unexplained shortness of breath
- congestive heart failure
- history of stroke
- transient ischemic attack
- carotid artery disease
- myocardial ischemia
- myocardial infarction
- restrictive or constrictive cardiomyopathy
- congenital heart disease other than patent foramen ovale, repaired atrial or ventricular septal defect
- any type of cardiac valve disease
- history of cardiac arrhythmias
Self-reported health conditions as identified in the Health Assessment Form
- diabetes
- uncontrolled thyroid disease
- kidney disease / chronic renal impairment
- history of seizures (except childhood febrile seizures)
- epilepsy
- history of unexplained syncope
- history of migraine attacks in the last 3 months
- head injury within the last 2 months
- cancer / chemotherapy
- other known health condition should be considered upon disclosure in health assessment form
- history of substance abuse or addiction to alcohol and or drugs within the last 12 months
Subjects with self-reported bleeding disorders including but not limited to:
- hemophilia
- von Willebrand disease
- history of blood clots
- history of bleeding problems
- bruises easily with everyday activities
- Subjects taking prescription blood thinners (like aspirin, clopidogrel, dipyridamole, or ticlopidine).
- Subjects may be excluded at the discretion of the Investigator.
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: Faisabilité de l'appareil
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: IV line with an attached Deltran BP transducer
After device setup, subjects will be guided through a series of manipulations of the IV set while waveforms, pulse rate (PR), respiratory rate (RR) are collected at the start and stop of each test.
At the end of the study, the PIVA algorithm will then be applied to the waveforms and calculated values will be compared with those from bedside monitors to understand the effect of common manipulations on the waveforms and determine most optimal conditions for capturing RR and PR through peripheral IV analysis.
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An IV line with an attached Deltran BP transducer will be used together with LabChart software to record venous waveforms during various interventions.
These waveforms will be processed using the PIVA algorithm and the calculated values will be compared to those from Nellcor respiratory monitor, Capnograph and cardiac telemetry monitoring.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Signal Quality Index (SQI) Score by Supine, Sitting, Standing Body Positions
Délai: End of interventions #15 (supine for 5 minutes), #17 (sitting for 5 minutes), and #19 (standing for 5 minutes)
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Ranking of subject body positions (supine, sitting, standing) based upon their impact on the venous waveform signal, from best to worst, based on the PIVA algorithm-derived SQI.
Score on the scale include 0=no signal, 1=poor signal, 2=good signal.
The highest percentage of time with good signal quality will be the best ranked position, and the lowest percentage of time with good signal quality will be the worst ranked position.
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End of interventions #15 (supine for 5 minutes), #17 (sitting for 5 minutes), and #19 (standing for 5 minutes)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Agreement between PIVA algorithm-derived RR and RR measured with Capnography at Baseline
Délai: End of 10 minute baseline
|
The difference of the PIVA algorithm-derived outcomes to their comparators (Capnography) under different conditions will be summarized descriptively by n, mean, median, minimum, and maximum.
The 95% limit of agreement and a Bland Altman plot will also be done for these endpoints.
Capnography is the monitoring of the concentration or partial pressure of carbon dioxide in the respiratory gases.
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End of 10 minute baseline
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Agreement between PIVA algorithm-derived RR and RR measured with Nellcor bedside monitor at Baseline
Délai: End of 10 minute baseline
|
The difference of the PIVA algorithm-derived outcomes to their comparators (Nellcor) under different conditions will be summarized descriptively by n, mean, median, minimum, and maximum.
The 95% limit of agreement and a Bland Altman plot will also be done for these endpoints.
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End of 10 minute baseline
|
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Agreement between PIVA algorithm-derived RR and RR measured with manual counting
Délai: End of 10 minute baseline
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The manual count value will be an average of the 2 minutes then the count is taken over.
The difference of the PIVA algorithm-derived outcomes to their comparators (manual) under different conditions will be summarized descriptively by n, mean, median, minimum, and maximum.
The 95% limit of agreement and a Bland Altman plot will also be done for these endpoints.
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End of 10 minute baseline
|
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Agreement between PIVA algorithm derived PR and PR measured with Nellcor bedside monitor at Baseline
Délai: End of 10 minute baseline
|
The difference of the PIVA algorithm-derived outcomes to their comparators (Nellcor) under different conditions will be summarized descriptively by n, mean, median, minimum, and maximum.
The 95% limit of agreement and a Bland Altman plot will also be done for these endpoints.
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End of 10 minute baseline
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Change in PIVA algorithm derived volume index between supine and passive leg raising positions
Délai: End of Interventions #15 (supine for 5 minutes) and #18 (passive leg raise for 5 minutes)
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The change in PIVA algorithm-derived volume index for a change in positions will be summarized descriptively by n, mean, median, minimum, and maximum.
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End of Interventions #15 (supine for 5 minutes) and #18 (passive leg raise for 5 minutes)
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Change in PIVA algorithm derived volume index between supine and standing positions
Délai: End of interventions #15 (supine for 5 minutes) and #19 (standing for 5 minutes)
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The change in PIVA algorithm-derived volume index for a change in positions will be summarized descriptively by n, mean, median, minimum, and maximum.
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End of interventions #15 (supine for 5 minutes) and #19 (standing for 5 minutes)
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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)
26 février 2020
Achèvement primaire (Réel)
21 mars 2020
Achèvement de l'étude (Réel)
21 mars 2020
Dates d'inscription aux études
Première soumission
25 mars 2020
Première soumission répondant aux critères de contrôle qualité
25 mars 2020
Première publication (Réel)
27 mars 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 avril 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 mars 2021
Dernière vérification
1 mars 2021
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- BXU544319
- Pro00041143 (Autre identifiant: Advarra)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
produit fabriqué et exporté des États-Unis.
Non
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 .