The Effect of Heat on Blood and Oxygen Flow Readings Part 2
This is the second part of a research study in order to determine if using a specialized pulse oximetry probe with external heat pack will help obtain oxygen saturation (SaO2) and heart rate (HR) during monitoring for patients with peripheral vascular disease (PVD), vasoconstriction, and hypothermic extremities. The inability to obtain accurate SaO2 and pulse readings can lead to misdiagnosis, incorrect treatment, or procedures to be canceled. SaO2 and pulse readings are important to maintain patient stability during diagnostic testing, surgical procedures and monitoring while in critical care areas. Changes in SaO2 and pulse are important to monitor in order to be able to compensate for any decrease in patient oxygen saturations during hemodynamic monitoring.
The primary aim of this study is to determine if using a specialized pulse oximetry probe with external heat pack will improve oxygenation readings in order to obtain SaO2 and pulse readings in patients with PVD, vasoconstriction, and hypothermic extremities as compared to readings obtained from an arterial blood gas.
The hypothesis is using a specialized pulse oximetry probe with external heat pack will help obtain more accurate pulse oximetry readings consistent with values obtained with an arterial blood gas.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Förenta staterna, 15240
- VA Pittsburgh Healthcare System
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Age > 18 years
- Able to give informed consent
- Patients must be able to read and understand English.
- Patients scheduled to enter the VA Pittsburgh Healthcare System catheterization lab
Arm 2 of the study:
1. The PI will determine if patients have poor circulation due to obstruction of the large arteries in their arms and legs (peripheral vascular disease (PVD), narrowing of their blood vessels (vasoconstriction), or extremities (arms, legs, etc) that are at least 3 degrees Fahrenheit below their normal body temperature. If patients do have any of the following they will be considered for arm 2. If they do not they will be considered for arm 1.
Exclusion Criteria:
In addition to the exclusions mentioned above, patients with the following conditions will be excluded from the trial:
1. Inability or unwillingness to sign informed consent with free will and sound mind, as determined by a score of <11 on the Evaluation to Sign Consent Form.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Non-Healthy Subjects arm
Subjects in this arm will have peripheral vascular disease (PVD), vasoconstriction, or hypothermic extremities and they will receive two pulse oximetry probes.
One probe will be a standard of care pulse oximetry probe and the second probe is the specialized pulse oximetry probe with external heat pack
|
Pulse oximetry will be obtained using the specialized pulse oximetry probe with external heat pack for 45 minutes.
Pulse oximetry will be obtained using a standard of care pulse oximetry probe for 45 minutes.
|
|
Aktiv komparator: Healthy Subjects Arm
Subjects who do not have peripheral vascular disease (PVD), vasoconstriction, or hypothermic extremities will be considered healthy subjects and they will receive two pulse oximetry probes.
One probe will be a standard of care pulse oximetry probe and the second probe is the specialized pulse oximetry probe with external heat pack.
|
Pulse oximetry will be obtained using the specialized pulse oximetry probe with external heat pack for 45 minutes.
Pulse oximetry will be obtained using a standard of care pulse oximetry probe for 45 minutes.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Pulse Oximetry
Tidsram: measured at least every 5 minutes - day 1
|
measured at least every 5 minutes - day 1
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Arterial Blood Gas
Tidsram: measured once - day 1
|
measured once - day 1
|
Andra resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Temperature
Tidsram: measured at least every 5 minutes - day 1
|
measured at least every 5 minutes - day 1
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Catherine Abee, CRT, VA Pittsburgh Healthcare System
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PulsOx-002
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Friska
-
University of MiamiJames and Esther King Biomedical Research ProgramAvslutadHealthy Lifetime Icke-rökareFörenta staterna
-
University of LeicesterNational Institute for Health Research, United KingdomAvslutadPatienter med hjärtsvikt och konserverad ejektionsfraktion - HFpEF | Patienter med hjärtsvikt med reducerad ejektionsfraktion - HFrEF | Healthy Controls Group - ålders- och könsmatchad
-
University Hospital, GrenobleUniversity Hospital, Clermont-Ferrand; Grenoble Institut des NeurosciencesAvslutadParkinsons sjukdom | Healthy Controls Group - ålders- och könsmatchadFrankrike