Detection of Exhaled Methane Levels in Hemorrhagic Shock
27 september 2021 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Förväntat)
40
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Péter Dr. Jávor, M.D.
- Telefonnummer: +36703193420
- E-post: peter.javor.md.@gmail.com
Studera Kontakt Backup
- Namn: Petra Dr. Hartmann, MD, Ph.D.
- Telefonnummer: +36304388695 +3662545531
- E-post: hatmann.petra@med.u-szeged.hu
Studieorter
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Szeged, Ungern, 6720
- Department of Traumatology, University of Szeged
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Kontakt:
- Eszter Bucsuház
- Telefonnummer: +3662545531
- E-post: office.trauma@med.u-szeged.hu
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Huvudutredare:
- Petra Dr. Hartmann, MD, Ph.D.
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
N/A
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Severely injured (ISS)≥16, intubated trauma patients with active bleeding.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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Hemorrhagic group
Patients with bleeding confirmed with eFAST or CT.
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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).
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.
Andra namn:
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.
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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Association between exhaled methane levels and vital signs
Tidsram: First 72 in-hospital hours
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We intend to investigate the relation between exhaled methane levels and systolic blood pressure and heart rate.
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First 72 in-hospital hours
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Association between exhaled methane levels and blood gas and laboratory markers
Tidsram: First 72 in-hospital hours
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We intend to investigate the relation between exhaled methane levels and blood gas and laboratory markers (base deficit, lactate, hemoglobin, hematocrit).
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First 72 in-hospital hours
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Association between exhaled methane levels and sublingual microcirculation
Tidsram: First 72 in-hospital hours
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We intend to investigate the relation between exhaled methane concentrations and sublingual microcirculation.
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First 72 in-hospital hours
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Association between exhaled methane levels and mortality
Tidsram: First 72 in-hospital hours
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The relation between exhaled methane levels and mortality will be assessed.
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First 72 in-hospital hours
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Association between exhaled methane levels and number of packed red blood cells required for transfusion/massive transfusion
Tidsram: First 72 in-hospital hours
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The relation between exhaled methane levels and the number of packed red blood cells required for transfusion/massive transfusion will be assessed.
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First 72 in-hospital hours
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Barsony A, Vida N, Gajda A, Rutai A, Mohacsi A, Szabo A, Boros M, Varga G, Erces D. Methane Exhalation Can Monitor the Microcirculatory Changes of the Intestinal Mucosa in a Large Animal Model of Hemorrhage and Fluid Resuscitation. Front Med (Lausanne). 2020 Oct 22;7:567260. doi: 10.3389/fmed.2020.567260. eCollection 2020.
- Szucs S, Bari G, Ugocsai M, Lashkarivand RA, Lajko N, Mohacsi A, Szabo A, Kaszaki J, Boros M, Erces D, Varga G. Detection of Intestinal Tissue Perfusion by Real-Time Breath Methane Analysis in Rat and Pig Models of Mesenteric Circulatory Distress. Crit Care Med. 2019 May;47(5):e403-e411. doi: 10.1097/CCM.0000000000003659.
- Szabo A, Unterkofler K, Mochalski P, Jandacka M, Ruzsanyi V, Szabo G, Mohacsi A, Teschl S, Teschl G, King J. Modeling of breath methane concentration profiles during exercise on an ergometer. J Breath Res. 2016 Feb 1;10(1):017105. doi: 10.1088/1752-7155/10/1/017105.
- Javor P, Rarosi F, Horvath T, Torok L, Varga E, Hartmann P. Detection of exhaled methane levels for monitoring trauma-related haemorrhage following blunt trauma: study protocol for a prospective observational study. BMJ Open. 2022 Jul 6;12(7):e057872. doi: 10.1136/bmjopen-2021-057872.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
1 november 2021
Primärt slutförande (Förväntat)
1 november 2022
Avslutad studie (Förväntat)
31 januari 2023
Studieregistreringsdatum
Först inskickad
27 juli 2021
Först inskickad som uppfyllde QC-kriterierna
27 juli 2021
Första postat (Faktisk)
3 augusti 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 september 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 september 2021
Senast verifierad
1 september 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 5400/2021-SZTE
Läkemedels- och apparatinformation, studiedokument
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