Detection of exhaled methane levels for monitoring trauma-related haemorrhage following blunt trauma: study protocol for a prospective observational study

Péter Jávor, Ferenc Rárosi, Tamara Horváth, László Török, Endre Varga, Petra Hartmann, Péter Jávor, Ferenc Rárosi, Tamara Horváth, László Török, Endre Varga, Petra Hartmann

Abstract

Introduction: Early recognition and effective treatment of internal bleeding impose a cardinal challenge for trauma teams. The reduction of the superior mesenteric artery (SMA) blood flow is among the first compensatory responses to blood loss, thus being a promising candidate as a diagnostic tool for occult haemorrhage. Unfortunately, methods for monitoring the SMA flow have not been elaborated to date. Nevertheless, animal experiments suggest that exhaled methane (CH4) levels correspond to the SMA perfusion. We hypothesise that real-time detection of CH4 concentrations in the exhaled air is an applicable technique for the early recognition of haemorrhage in severely injured patients. We also hypothesise that exhaled CH4 levels reflect the volume of blood loss more accurately than conventional markers of blood loss and shock such as shock index, haemoglobin, base deficit, lactate, end-tidal carbon dioxide and sublingual microcirculatory indices.

Methods and analysis: One hundred and eleven severely injured (Injury Severity Score ≥16), intubated, bleeding patients sustaining blunt trauma will be included in this prospective observational study. Blood loss will be detected with CT and estimated with CT-linked radiologic software. Exhaled CH4 concentrations will be monitored by attaching a near-infrared laser technique-based photoacoustic spectroscopy apparatus to the exhalation outlet of the ventilator on patient arrival. The primary outcome is the volume of blood loss. Need for massive transfusion and 24-hour mortality will constitute secondary outcomes. The relation of exhaled CH4 to study outcomes and its performance in predicting blood loss in comparison with conventional shock markers and microcirculatory indices will be tested.

Ethics and dissemination: Our protocol (ID: 5400/2021-SZTE) has been registered on ClinicalTrials.gov (NCT04987411) and complies with the Declaration of Helsinki and has been approved by the medical ethics committee at the University of Szeged (Ref.nr.:121/2021-SZTE RKEB). It is in data collection phase, theresults will be shared with the scientific community through publication in a peer-reviewed journal.

Trial registration number: NCT04987411; ClinicalTrials.gov, registered on 27 July 2021.

Keywords: ACCIDENT & EMERGENCY MEDICINE; Bleeding disorders & coagulopathies; Protocols & guidelines; TRAUMA MANAGEMENT; Trauma management.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Protocol flowchart. (A) Aspects of patient enrolment and reasons for exclusion are demonstrated. Severely injured (ISS≥16), blunt trauma patients with bleeding will be enrolled into our study. CT will be used to detect the presence and evaluate the severity of bleeding, and for aiding the assessment of injury severity. Signed informed consent from patients or their surrogates will be required for patient enrolment. Inclusion criteria include intubation as the exhalation outlet of the ventilator allows the attachment of the CH4 detector apparatus, thus the continuous monitoring of CH4 levels in breath. Patients with penetrating trauma, bleeding outwards, grade II and III fractures, isolated TBI, ARDS or ALI will be excluded from the analysis. (B) Study participants will undergo a comprehensive haemodynamic assessment on arrival, which consists of evaluation of VS (HR, SBP), ETCO2, ABG (BD, lactate), laboratory tests (Hb, Hct), VM of the sublingual mucosa using orthogonal polarisation spectral imaging, eFAST, and polytrauma CT. With the help of these parameters, a detailed dataset describing the haemodynamic state of the participants will be provided. Exhaled CH4 concentrations will be monitored with a near-infrared laser technique-based PAS apparatus. (C) Our clinical outcomes will include the volume of blood that patients have already lost at the time of their arrival, the need for a MBT, and 24-hour mortality. To calculate to volume of blood loss, a CT-linked radiologic software will be used. Associations between exhaled CH4 concentrations and clinical outcomes will be assessed. ABG, arterial blood gas; ALI, acute lung injury; ARDS, acute respiratory distress syndrome; BD, base deficit; CH4, methane; eFAST, extended focused assessment with sonography for trauma; ETCO2, end-tidal carbon dioxide; Hb, haemoglobin; Hct, hematocrit; HR, heart rate; ISS, Injury Severity Score; PAS, photoacoustic spectroscopy; SBP, systolic blood pressure; TBI, traumatic brain injury; VM, videomicroscopy; vs, vital signs.

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