Detection of Exhaled Methane Levels in Hemorrhagic Shock

University of Szeged (SZTE)

Status: Unknown

Conditions: Trauma; Hemorrhagic Shock

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

Study type: Observational

Funder types: Other

Identifiers

NCT04987411

5400/2021-SZTE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

40 participants in 1 patient group

Hemorrhagic group

Description:

Patients with bleeding confirmed with eFAST or CT.

Treatment:

Diagnostic Test: Measurement of methane concentrations in exhaled breath

Diagnostic Test: Videomicroscopy of the sublingual microcirculation

Diagnostic Test: Hemodynamic monitoring

Diagnostic Test: Blood gas and laboratory analysis