Detection of Exhaled Methane Levels in Hemorrhagic Shock

September 27, 2021 updated by: Petra Hartmann MD Ph.D., Szeged University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hungary
      • Szeged, Hungary, 6720
        • Department of Traumatology, University of Szeged
        • Contact:
        • Principal Investigator:
          • Petra Dr. Hartmann, MD, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hemorrhagic group
Patients with bleeding confirmed with eFAST or CT.
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).
Diagnostic test: 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.
Other Names:
  • Videomicroscopy using orthogonal polarization spectral imaging (Cytoscan A/R Cytometrics)
Diagnostic test: 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.
Diagnostic test: 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.
Other Names:
  • Monitoring vital signs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between exhaled methane levels and vital signs
Time Frame: First 72 in-hospital hours
We intend to investigate the relation between exhaled methane levels and systolic blood pressure and heart rate.
First 72 in-hospital hours
Association between exhaled methane levels and blood gas and laboratory markers
Time Frame: First 72 in-hospital hours
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
Association between exhaled methane levels and sublingual microcirculation
Time Frame: First 72 in-hospital hours
We intend to investigate the relation between exhaled methane concentrations and sublingual microcirculation.
First 72 in-hospital hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between exhaled methane levels and mortality
Time Frame: First 72 in-hospital hours
The relation between exhaled methane levels and mortality will be assessed.
First 72 in-hospital hours
Association between exhaled methane levels and number of packed red blood cells required for transfusion/massive transfusion
Time Frame: First 72 in-hospital hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Szeged University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

January 31, 2023

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

July 27, 2021

First Posted (Actual)

August 3, 2021

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5400/2021-SZTE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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