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Comparison of Cardiac Output With LiDCO Rapid and TEE Against Thermodilution Technique in Cardiac Surgery

24. oktober 2016 opdateret af: Sudhakar Subramani, University of Iowa

Validation of Measurement of Cardiac Output With LiDCO Rapid and TEE (Trans Esophageal Echocardiography) by Comparing With Intermittent Thermodilution Technique in Cardiac Surgical Patients

Measurement of the cardiac output is one of the important hemodynamic monitoring tools in cardiac surgery. It helps determine the type of medications needed to maintain optimal hemodynamic status in the entire perioperative period. Thermodilution method using pulmonary artery catheter is considered has the gold standard for the measurement of cardiac output. Investigators would like to compare the most popular minimally-invasive devices used to measure cardiac output using arterial waveform: LiDCO Rapid and TEE with the thermodilution method at various phases of the cardiac surgery.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Measurement of the cardiac output is one of the important hemodynamic monitoring tools in cardiac surgery. It helps determine the type of medications needed to maintain optimal hemodynamic status in the entire perioperative period. Thermodilution method using pulmonary artery catheter is considered has the gold standard for the measurement of cardiac output, however over the past 10 to 15 years it has been questioned about its safety and efficacy. There has been a surge in recent years of less invasive devices capable of measuring cardiac output by various means, including bioimpedance, transpulmonary thermodilution, transthoracic and transesophageal echocardiography, and arterial waveform analysis.

There is a variety of devices currently available for cardiac output measurement by arterial-waveform analysis. These devices have been compared to each other, and to the pulmonary artery catheter as the gold standard. However, the companies manufacturing these devices have made software upgrades that they believe improves their performance. No studies have been performed comparing the uncalibrated arterial waveform based cardiac output measurement device,LiDCORapid since the software upgrades. In addition to baseline cardiac output measurements, Investigators intend to study the effect of volume loading (by trendelenburg position), sympathetic stimulus (incision), a vasodilated state (15 minutes after separation from CPB) and chest closure on cardiac output measured by the three different techniques.

In addition to cardiac output the investigators would like to measure stroke volume ,Systemic Vascular Resistance, stroke volume variation with LiDCO . The main purpose is to validate the accuracy of measurements by these two minimally-invasive methods in comparison with thermodilution method in various hemodynamic states.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

110

Kontakter og lokationer

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Studiesteder

    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • University of Iowa

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

30 år til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

All elective adult cardiac surgery patients who are scheduled in UIHC from Sep 2012 to August 2015 will be included.

Beskrivelse

Inclusion Criteria:

  • Elective cardiac procedures other than those specified in the exclusion criteria

Exclusion Criteria:

  • All emergency cardiac procedures, prisoners and pregnant women, patients who are scheduled for ventricular assist devices and those with severe aortic, mitral and tricuspid insufficiency will be excluded.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The primary objective of the study is measured cardiac output by LiDCO Rapid is as equivalent ( within 30%) as measured by pulmonary artery catheter using intermittent thermodilution method among patients undergoing elective cardiac surgery.
Tidsramme: During intraoperative period.
During intraoperative period.

Sekundære resultatmål

Resultatmål
Tidsramme
The secondary objective of the study is measured cardiac output by TEE using VTI at LVOT is as equivalent ( within 30%) as measured by pulmonary artery catheter using intermittent thermodilution method among patients undergoing elective cardiac surgery.
Tidsramme: During intraoperative period
During intraoperative period

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Sudhakar Subramani, M.D., University of Iowa

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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. oktober 2012

Primær færdiggørelse (Faktiske)

1. august 2015

Studieafslutning (Faktiske)

1. august 2015

Datoer for studieregistrering

Først indsendt

24. juli 2015

Først indsendt, der opfyldte QC-kriterier

29. juli 2015

Først opslået (Skøn)

30. juli 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. oktober 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. oktober 2016

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 201205760

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 .

Kliniske forsøg med Lavt hjerteoutput

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