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Detection of Exhaled Methane Levels in Hemorrhagic Shock

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04987411
Enrollment
40
Registered
2021-08-03
Start date
2021-11-01
Completion date
2023-01-31
Last updated
2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhagic Shock, Trauma

Keywords

shock, hemorrhagic, methane

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTMeasurement 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).

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.

DIAGNOSTIC_TESTBlood 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.

DIAGNOSTIC_TESTHemodynamic 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.

Sponsors

Szeged University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Association between exhaled methane levels and blood gas and laboratory markersFirst 72 in-hospital hoursWe intend to investigate the relation between exhaled methane levels and blood gas and laboratory markers (base deficit, lactate, hemoglobin, hematocrit).
Association between exhaled methane levels and vital signsFirst 72 in-hospital hoursWe intend to investigate the relation between exhaled methane levels and systolic blood pressure and heart rate.
Association between exhaled methane levels and sublingual microcirculationFirst 72 in-hospital hoursWe intend to investigate the relation between exhaled methane concentrations and sublingual microcirculation.

Secondary

MeasureTime frameDescription
Association between exhaled methane levels and mortalityFirst 72 in-hospital hoursThe relation between exhaled methane levels and mortality will be assessed.
Association between exhaled methane levels and number of packed red blood cells required for transfusion/massive transfusionFirst 72 in-hospital hoursThe relation between exhaled methane levels and the number of packed red blood cells required for transfusion/massive transfusion will be assessed.

Countries

Hungary

Contacts

Primary ContactPetra Dr. Hartmann, MD, Ph.D.
hatmann.petra@med.u-szeged.hu+3662545531
Backup ContactPéter Dr. Jávor, M.D.
peter.javor.md.@gmail.com+36703193420

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026