Detection of Exhaled Methane Levels in Hemorrhagic Shock

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04987411
• Other study ID #: 5400/2021-SZTE
• Status: Not yet recruiting
• Start date: November 1, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: September 2021
• Source: Szeged University
• Contact: Petra Dr. Hartmann, MD, Ph.D.
• Phone: +3662545531
• Email: hatmann.petra[@]med.u-szeged.hu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 31, 2023
• Est. primary completion date: November 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhagic Shock
• Shock
• Shock, Hemorrhagic
• Trauma

Intervention

Diagnostic 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).
• 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.

Locations

Country	Name	City	State
Hungary	Department of Traumatology, University of Szeged	Szeged

Sponsors (1)

Lead Sponsor	Collaborator
Szeged University

Country where clinical trial is conducted

Hungary, 

References & Publications (3)

Bársony A, Vida N, Gajda Á, Rutai A, Mohácsi Á, Szabó A, Boros M, Varga G, Érces 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. — View Citation

Szabó A, Unterkofler K, Mochalski P, Jandacka M, Ruzsanyi V, Szabó G, Mohácsi Á, 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. — View Citation

Szucs S, Bari G, Ugocsai M, Lashkarivand RA, Lajkó N, Mohácsi Á, Szabó A, Kaszaki J, Boros M, Érces 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Association between exhaled methane levels and mortality	The relation between exhaled methane levels and mortality will be assessed.	First 72 in-hospital hours
Secondary	Association between exhaled methane levels and number of packed red blood cells required for transfusion/massive transfusion	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