Detection of Exhaled Methane Levels in Hemorrhagic Shock

NCT04987411 | Unknown

• 1 other identifier: 5400/2021-SZTE
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhagic Shock; Trauma

Keywords

shock; hemorrhagic; methane

Outcome Measures

Primary Outcomes (3)

• Association between exhaled methane levels and vital signs

  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

  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

  We intend to investigate the relation between exhaled methane concentrations and sublingual microcirculation.

  First 72 in-hospital hours

Secondary Outcomes (2)

• Association between exhaled methane levels and mortality

  First 72 in-hospital hours

• Association between exhaled methane levels and number of packed red blood cells required for transfusion/massive transfusion

  First 72 in-hospital hours

Study Arms (1)

Hemorrhagic group

Patients with bleeding confirmed with eFAST or CT.

Diagnostic Test: Measurement of methane concentrations in exhaled breath; Diagnostic Test: Videomicroscopy of the sublingual microcirculation; Diagnostic Test: Blood gas and laboratory analysis; Diagnostic Test: Hemodynamic monitoring

Interventions

Measurement of methane concentrations in exhaled breath DIAGNOSTIC_TEST

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).

Hemorrhagic group

Videomicroscopy of the sublingual microcirculation DIAGNOSTIC_TEST

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.

Also known as: Videomicroscopy using orthogonal polarization spectral imaging (Cytoscan A/R Cytometrics)

Hemorrhagic group

Blood gas and laboratory analysis DIAGNOSTIC_TEST

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.

Hemorrhagic group

Hemodynamic monitoring DIAGNOSTIC_TEST

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.

Also known as: Monitoring vital signs

Hemorrhagic group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

Sponsors & Collaborators

• Szeged University: lead

Study Sites (1)

Department of Traumatology, University of Szeged

Szeged, 6720, Hungary

Location

Related Publications (4)

• 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.

  PMID: 33195312 BACKGROUND

• 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.

  PMID: 30985462 BACKGROUND

• 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.

  PMID: 26828421 BACKGROUND

• 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.

  PMID: 35793921 DERIVED

MeSH Terms

Conditions

Shock, Hemorrhagic; Wounds and Injuries; Shock

Interventions

Blood Gas Analysis; Hemodynamic Monitoring; Vital Signs

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques; Diagnostic Techniques, Cardiovascular; Monitoring, Physiologic; Physical Examination

Central Study Contacts

Petra Dr. Hartmann, MD, Ph.D.

CONTACT

+3662545531; hatmann.petra@med.u-szeged.hu

Péter Dr. Jávor, M.D.

CONTACT

+36703193420; peter.javor.md.@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 3, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: January 31, 2023
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

HU (1)