- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01714583
The Relationship Between Positive End Expiratory Pressure and Cardiac Index in Patients With Acute Respiratory Distress Syndrome (ARDS) Managed on a Fluid Protocol
The Relationship Between Positive End Expiratory Pressure and Cardiac Index in Patients With ARDS Managed on a Fluid Protocol: A Secondary Analysis of a Prospective Trial
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06510
- Yale University, School of Medicine, Department of Internal Medicine, Section of Pulmonary and Critical Care Medicine
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
Acute lung injury diagnosis (as defined by The American - European Consensus Conference on ARDS) of < 48 hours in duration.
Patients in the Pulmonary Artery catheter (PAC) arm of the FACTT study. PaO2 / FiO2 ratio of < 200. Data from the first 3 days of mechanical ventilation.
Exclusion Criteria:
Select chronic conditions that could independently influence survival (e.g., expected 6-month survival < 50%) and / or ventilator weaning.
PEEP values missing. FiO2 values missing. PaO2 values missing. Cardiac index values missing Pressors and / or inotropes requirement.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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High PEEP
Cohort of participants with positive end-expiratory pressure (PEEP) greater than or equal to 12cm.
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Low PEEP
Cohort of participants with positive end-expiratory pressure (PEEP) less than 12cm.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Cardiac Index
Tidsramme: Cross sectional (i.e. at time Zero only)
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The cardiac index is a cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index. The cardiac index which is the outcome measure is assessed at the same time as the PEEP (which is the independent variable) is measured. The study participants are NOT followed for any period of time. This is a cross-sectional study design. Both variables (Cardiac index and PEEP) are measured at the same time. |
Cross sectional (i.e. at time Zero only)
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Wassim H Fares, MD MSc, Yale University, School of Medicine, Department of Internal Medicine, Section of Pulmonary and Critical Care Medicine
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NHLBI T32 HL007106-34
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