Detection of Exhaled Methane Levels in Hemorrhagic Shock

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Hemorrhagic Shock, Trauma

Being tested

Measurement of methane concentrations in exhaled breath, Videomicroscopy of the sublingual microcirculation, Blood gas and laboratory analysis, Hemodynamic monitoring

Keywords

shock, hemorrhagic, methane

Medical subject headings

Shock, Hemorrhagic, Wounds and Injuries, Shock

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Measurement of methane concentrations in exhaled breathDiagnostic 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).

• Videomicroscopy of the sublingual microcirculationDiagnostic test

  Also called Videomicroscopy using orthogonal polarization spectral imaging (Cytoscan A/R Cytometrics)

  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 analysisDiagnostic 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.

• Hemodynamic monitoringDiagnostic test

  Also called Monitoring vital signs

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: First 72 in-hospital hours

2. 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).

   Measured: First 72 in-hospital hours

3. Association between exhaled methane levels and sublingual microcirculation

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

   Measured: First 72 in-hospital hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted3 Aug 2021
2. Study start1 Nov 2021 (estimated)
3. Primary completion1 Nov 2022 (estimated)
4. Study completion31 Jan 2023 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (4)Papers the sponsor has linked to this study.
• Other trials for Hemorrhagic ShockStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.