Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients
19. maj 2017 opdateret af: Kevin Kuo, University of Michigan
Investigators are conducting research about oxygen levels in the body and whether it is possible to use a device to measure oxygen in the body's tissues noninvasively, without blood draws or a catheter (a plastic tube placed in a vein).
Investigators would like to know how this device compares to standard measurements using blood from a catheter.
This may help treat patients who may not be getting enough oxygen to their body.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
Investigators will enroll patients in the pediatric intensive care unit who have an indwelling catheter that allows measurement of central venous oxygen saturation.
Measurements of central venous oxygen saturation using blood oximetry will be compared with measures of tissue oxygenation at the buccal mucosa using a Raman spectroscopy tissue oximeter.
Investigators will also measure the status of the sublingual microcirculation utilizing sidestream dark field microscopy.
Basic demographic and clinical variables such as ongoing vasoactive infusions, mechanical ventilation, and laboratory data will also be collected.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
46
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48109
- C.S. Mott Children's Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 måned til 18 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients admitted to the Pediatric Intensive Care Unit (PICU) or Pediatric Cardiothoracic Unit (PCTU)
- Age >30 days and <18 years -patients with a "high" central venous line (ie internal jugular, subclavian, peripherally inserted central catheter, broviac, port) capable of blood draw and with central venous catheter tip in the superior vena cava
Exclusion Criteria:
- Age <30 days or >18 years
- Known pregnancy or subsequently discovered pregnancy after admission
- Uncorrected cyanotic congenital heart disease
Relative Exclusion Criteria:
- Oral trauma preventing placement of Raman StO2 oximeter probe or microcirculation video device
- Upper extremity trauma preventing placement of BEAM device
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Enhedens gennemførlighed
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Tissue oxygenation monitoring
|
The device provides continuous measures with updates based on the previous 10 seconds worth of data.
Data is continuously stored.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
tissue oxygenation level as measured by raman spectroscopy device
Tidsramme: The measures will occur twice within the first 24 hours of admission to the pediatric ICU and then whenever a central venous oxygen saturation is measured by the clinical care team until the patient is discharged from the pediatric ICU.
|
Measurement of tissue oxygenation level as based upon raman spectroscopy device will be compared with standard measures from central venous oxygen saturation from central venous catheters.
|
The measures will occur twice within the first 24 hours of admission to the pediatric ICU and then whenever a central venous oxygen saturation is measured by the clinical care team until the patient is discharged from the pediatric ICU.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Microcirculation as recorded by sublingual video microcirculation recorder.
Tidsramme: Twice in the first 24 hours after PICU admission
|
Two video clips will be recorded of the sublingual microcirculation in each patient within the first 24 hours of admission to the PICU.
|
Twice in the first 24 hours after PICU admission
|
|
Vital signs as recorded by Bioinformatically enabled armband monitor (BEAM)
Tidsramme: Continuous from PICU admission through 24 hours of admission
|
Bioinformatically enabled armband monitor (BEAM) will be placed on the patient's upper extremity for the first 24 hours of their admission and will be subsequently removed.
The data will be stored in the device and investigators and clinicians caring for subjects will be blinded to the device output as data is collected.
The device continually captures physiologic data such as heart rate, ECG results, and temperature.
|
Continuous from PICU admission through 24 hours of admission
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Kevin Ward, MD, University of Michigan
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2013
Primær færdiggørelse (Faktiske)
1. november 2014
Studieafslutning (Faktiske)
1. november 2014
Datoer for studieregistrering
Først indsendt
28. december 2012
Først indsendt, der opfyldte QC-kriterier
28. december 2012
Først opslået (Skøn)
3. januar 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. maj 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. maj 2017
Sidst verificeret
1. maj 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NATP001
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .