Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Detection of Exhaled Methane Levels in Hemorrhagic Shock

27. september 2021 opdateret af: Petra Hartmann MD Ph.D., Szeged University

Detection of Exhaled Methane Levels for the Recognition and Monitoring of Hemorrhagic Shock - Study Protocol for a Prospective Observational Study

This prospective observational study aims to test the efficacy of the continuous measurement of exhaled methane levels in monitoring the hemodynamic state of severely injured, bleeding trauma patients.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This prospective observational study aims to test the efficacy of the continuous measurement of exhaled methane levels in monitoring the hemodynamic state of severely injured, bleeding trauma patients. Our inclusion criteria require an age of 18 years or greater, an Injury Severity Score (ISS) of 16 or greater, transport directly from scene, intubation on scene or upon arrival, hemorrhage confirmed with eFAST or CT, and signed consent from patient surrogates. Exhaled methane concentrations and indicators of blood loss and shock (vital signs: systolic blood pressure, heart rate; blood gas and laboratory markers: base deficit, lactate, hemoglobin, hematocrit; videomicroscopic image of sublingual microcirculation) will be recorded in pre-determined time points during the first 72 in-hospital hours. The relation between exhaled methane levels and indicators of shock will constitute our primary outcome measures. The association of methane concentrations with clinical outcomes (transfusion need, mortality) will serve as secondary outcomes.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

40

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Ungarn
      • Szeged, Ungarn, 6720
        • Department of Traumatology, University of Szeged
        • Kontakt:
        • Ledende efterforsker:
          • Petra Dr. Hartmann, MD, Ph.D.

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

N/A

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Severely injured (ISS)≥16, intubated trauma patients with active bleeding.

Beskrivelse

Inclusion Criteria:

  • injury severity score (ISS)≥16
  • intubated on scene or upon arrival
  • transported directly from scene to the Emergency Department of the University of Szeged
  • hemorrhage confirmed with eFAST or CT
  • consent signed by patient surrogate

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Hemorrhagic group
Patients with bleeding confirmed with eFAST or CT.
Diagnostisk test: Measurement of methane concentrations in exhaled breath
To measure methane concentrations, a near-infrared laser technique-based photoacoustic apparatus will be attached to the exhalation outlet of the ventilator upon arrival of severely injured patients. Exhaled methane levels will be monitored continuously during the first 72 in-hospital hours and will be recorded at pre-determined time points (directly upon arrival, 6 hours post-admission, 12 hours post-admission, 24 hours post-admission, 48 hours post-admission and 72 hours post-admission).
Diagnostisk test: Videomicroscopy of the sublingual microcirculation
Orthogonal polarization spectral imaging technique (Cytoscan A/R, Cytometrics) will be used to visualize the microcirculation of the sublingual mucosa of the patients. The OPS technique utilizes reflected, polarized light at the wavelength of the isobestic point of oxyhemoglobin and deoxyhemoglobin (548 nm). The diminution of sublingual microcirculation can refer to circulatory redistribution due to hemorrhage. Sublingual microcirculation of the patients will be visualized and evaluated at pre-determined time points (directly upon arrival, 6 hours post-admission, 12 hours post-admission, 24 hours post-admission, 48 hours post-admission and 72 hours post-admission) during the first 72 in-hospital hours.
Andre navne:
  • Videomicroscopy using orthogonal polarization spectral imaging (Cytoscan A/R Cytometrics)
Diagnostisk test: Blood gas and laboratory analysis
Arterial blood gas analysis and laboratory testing of venous blood are routine examinations in clinical practice. Base deficit and lactate are considered as global markers of blood loss and shock, and can be obtained rapidly with blood gas analysis. Hemoglobin and hematocrit values can correspond to the severity of blood loss, and are measured routinely both from arterial and venous blood. Sampling of arterial and venous blood for blood gas and laboratory analyses will be performed at pre-determined time points (directly upon arrival, 24 hours post-admission, 48 hours post-admission and 72 hours post-admission) during the first 72 in-hospital hours.
Diagnostisk test: Hemodynamic monitoring
Hemodynamic monitoring is an essential part of emergency trauma care. Non-invasive monitoring of blood pressure, heart rate and respiratory rate of patients will be started immediately upon arrival. After patients are stabilized, invasive arterial blood pressure (IABP) monitoring can be started. IABP is considered as the gold standard of blood pressure measurement in critical care as it reflects the fluctuations of blood pressure in real time. Blood pressure and heart rate values will be recorded at pre-determined time points (directly upon arrival, 6 hours post-admission, 12 hours post-admission, 24 hours post-admission, 48 hours post-admission and 72 hours post-admission) during the first 72 in-hospital hours.
Andre navne:
  • Monitoring vital signs

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Association between exhaled methane levels and vital signs
Tidsramme: First 72 in-hospital hours
We intend to investigate the relation between exhaled methane levels and systolic blood pressure and heart rate.
First 72 in-hospital hours
Association between exhaled methane levels and blood gas and laboratory markers
Tidsramme: First 72 in-hospital hours
We intend to investigate the relation between exhaled methane levels and blood gas and laboratory markers (base deficit, lactate, hemoglobin, hematocrit).
First 72 in-hospital hours
Association between exhaled methane levels and sublingual microcirculation
Tidsramme: First 72 in-hospital hours
We intend to investigate the relation between exhaled methane concentrations and sublingual microcirculation.
First 72 in-hospital hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Association between exhaled methane levels and mortality
Tidsramme: First 72 in-hospital hours
The relation between exhaled methane levels and mortality will be assessed.
First 72 in-hospital hours
Association between exhaled methane levels and number of packed red blood cells required for transfusion/massive transfusion
Tidsramme: First 72 in-hospital hours
The relation between exhaled methane levels and the number of packed red blood cells required for transfusion/massive transfusion will be assessed.
First 72 in-hospital hours

Samarbejdspartnere og efterforskere

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

Sponsor

Szeged University

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.

Generelle publikationer

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 (Forventet)

1. november 2021

Primær færdiggørelse (Forventet)

1. november 2022

Studieafslutning (Forventet)

31. januar 2023

Datoer for studieregistrering

Først indsendt

27. juli 2021

Først indsendt, der opfyldte QC-kriterier

27. juli 2021

Først opslået (Faktiske)

3. august 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. september 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. september 2021

Sidst verificeret

1. september 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 5400/2021-SZTE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 .

Abonner