Clinical trial NCT04987411: Detection of Exhaled Methane Levels in Hemorrhagic Shock
Official title: Detection of Exhaled Methane Levels for the Recognition and Monitoring of Hemorrhagic Shock - Study Protocol for a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemorrhagic Shock
Trauma
Keywords: shock
hemorrhagic
methane
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severely injured (ISS)≥16, intubated trauma patients with active bleeding.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Association between exhaled methane levels and vital signs
timeFrame: First 72 in-hospital hours
measure: Association between exhaled methane levels and blood gas and laboratory markers
timeFrame: First 72 in-hospital hours
measure: Association between exhaled methane levels and sublingual microcirculation
timeFrame: First 72 in-hospital hours
Secondary outcomes:
measure: Association between exhaled methane levels and mortality
timeFrame: First 72 in-hospital hours
measure: Association between exhaled methane levels and number of packed red blood cells required for transfusion/massive transfusion
timeFrame: First 72 in-hospital hours
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: Department of Traumatology, University of Szeged
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.