Venovenous CO2 Removal (VVCO2R) in Patients With COPD and Acute Respiratory Failure (VVCO2R)
15. februar 2019 opdateret af: The University of Texas Medical Branch, Galveston
Safety and Efficacy of Venovenous Carbon Dioxide Removal in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Acute Respiratory Failure (ARF)
The purpose of this study to determine the safety and effectiveness of a mechanical device to remove carbon dioxide from the blood of patients with chronic obstructive pulmonary disease (COPD)when they are hospitalized in the intensive care unit for exacerbation of their condition.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a pilot study to examine the efficacy and safety of an extracorporeal circuit to remove carbon dioxide (CO2) from the blood in patients with an acute exacerbation of COPD resulting in acute or acute on chronic respiratory failure.
The extracorporeal circuit consists of venovenous configuration through a percutaneously inserted 18 F double lumen catheter placed in a central vein.
Centrifugal pump and heparin bonded circuit are used and patient is heparinized to maintain an activated clotting time (ACT) > 180.
Circuit blood flow and gas sweep speed will be adjusted to maximize CO2 removal and minimize ventilator settings and patient's work of breathing.
Patients will remain on the extracorporeal circuit for a maximum of four days as tolerated.
Plasma Hemoglobin will be monitored daily.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Texas
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Galveston, Texas, Forenede Stater, 77555
- University of Texas Medical Branch
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Acute respiratory failure on invasive mechanical ventilation or
- Acute respiratory failure and an advanced directive foregoing invasive mechanical ventilation
- Established diagnosis of COPD
- Age group: 18 years or greater
Exclusion Criteria:
- Significant vasopressor support
- Systolic BP < 100 torr systolic despite vasopressor support
- Class III or Class IV congestive heart failure
- Left ventricular ejection fraction < 30% by previous echocardiogram
- Recent (6 month) history of myocardial infarction
- Coronary artery disease with unstable angina
- Recent (6 month) history of venous embolism
- Uncontrolled coagulopathy (international normalized ratio (INR) > 5 or activated partial thromboplastin time (aPTT) > 80s) despite corrective therapy
- History of heparin-induced thrombocytopenia or other adverse event following the administration of heparin (heparin group only)
- Pregnancy
- Severe chronic liver disease
- Severe anemia (Hgb < 9 gm/dl)
- Any contraindication to systemic anticoagulation with heparin, including recent central nervous system injury or hemorrhage, retinal hemorrhage or other recent hemorrhage from sites which cannot be controlled
- Technically unable to access vessels (obesity, limb deformity, previous surgery at the site, infection, etc.)
- Evidence of increased intracranial pressure or history of an intracranial hemorrhage within the past 3 months
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Venovenous CO2 Removal (VVCO2R) in COPD
All patients enrolled in the trial will receive VVCO2R which consists of a circuit with a centrifugal pump, tubing, double lumen intravenous catheter and hollow fiber oxygenator
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Patients who meet criteria will be placed on an extracorporeal circuit consisting of an oxygenator, centrifugal pump, tubing and indwelling double lumen venous catheter for CO2 removal for up to 96 hours for treatment of COPD exacerbation requiring hospitalization and intensive care
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The Amount of CO2 Transferred Through the Oxygenator at Various Levels of Blood and Gas Flow
Tidsramme: 0 to 96 hours
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The amount of CO2 removed in cc/min will be recorded.
The level of blood flow (ml/min) and gas flow (l/min) at each measurement of CO2 removal will also be recorded
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0 to 96 hours
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Victor J Cardenas, Jr, MD, University of Texas
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 2008
Primær færdiggørelse (Faktiske)
1. marts 2011
Studieafslutning (Faktiske)
1. marts 2011
Datoer for studieregistrering
Først indsendt
17. december 2007
Først indsendt, der opfyldte QC-kriterier
2. januar 2008
Først opslået (Skøn)
15. januar 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. marts 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. februar 2019
Sidst verificeret
1. september 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 03-142
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 .