Detection of Exhaled Methane Levels in Hemorrhagic Shock
NCT ID: NCT04987411
Last Updated: 2021-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2021-11-01
2023-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Hemorrhagic group
Patients with bleeding confirmed with eFAST or CT.
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).
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.
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.
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.
Interventions
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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).
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Szeged University
OTHER
Responsible Party
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Petra Hartmann MD Ph.D.
M.D., Ph.D.
Locations
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Department of Traumatology, University of Szeged
Szeged, , Hungary
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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5400/2021-SZTE
Identifier Type: -
Identifier Source: org_study_id
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