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Completed

NCT Number: NCT04857242

Electrical Impedance Tomography Measurements During Apnea Test in Patients With Suspected Brain Death

Apnea testing is the final decisive examination in the strictly regulated process of brain death assessment. There is no standardized method found in the literature for apnea testing except for the inspection of possible spontaneous chest movements. In addition, the test itself lasts for several minutes leading to the collapse of the lungs.

Electrical impedance tomography (EIT) is a non-invasive, real-time monitoring technique, which is suitable for detecting changes in lung volumes during ventilation. With its help, one can examine the spontaneous initiation of inspiration, the development of atelectasis and the reopening of collapsed regions by mechanical ventilation.

Furthermore, the apnea test provides for analysing the effect of changes in pulmonary perfusion on impedance in the absence of noise generated by ventilation.

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Key information

Conditions

Brain Death Brain Diseases Central Nervous System Diseases Coma Consciousness Disorders Death Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Unconsciousness

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Szeged

Szeged, 6725, Hungary

About this study

The aim of the study is to assess the eligibility of electrical impedance monitoring for the detection of possible spontaneous initiations of inspiration during apnea test in patients with suspected brain death. The study could contribute to the opening of new areas in the clinical use of the electrical impedance device. An additional aim is to observe the collapse and the reopening by recruitment manoeuvers of different pulmonary regions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with suspected brain death undergoing apnea test for detecting the absence of spontaneous breathing

Exclusion criteria

  • age under 18
  • pregnancy
  • pulmonectomy, lung resection in the past medical history
  • clinically end stage chronic obstructive pulmonary disease (COPD)
  • severe hemodynamic instability (vasopressor refractory shock)
  • severe bullous emphysema and/or spontaneous pneumothorax in the past medical history
  • chest drainage in situ due to pneumothorax and/or bronchopleural fistula

Treatment and study plan

Apnea test, alveolar recruitment

Diagnostic Test

Alveolar recruitment following the phase of apnea testing

Primary outcomes

  1. detection of spontaneous inspiration

    Time frame: 20 minutes

    Detection of absolute changes in impedance using EIT during apnea test, which may refer to spontaneous initiations of inspiration

Secondary outcomes

  1. Gas exchange

    Time frame: 20 minutes

    Change in arterial partial pressure of oxygen (PaO2) (mmHg) following alveolar recruitment performed after apnea testing

  2. Dynamic compliance

    Time frame: 20 minutes

    Change in dynamic compliance (ml/cmH2O) following alveolar recruitment

  3. End expiratory lung impedance

    Time frame: 20 minutes

    Change in end expiratory lung impedance (EELI) (%) following alveolar recruitment

  4. Center of ventilation

    Time frame: 20 minutes

    Change in center of ventilation (%) following alveolar recruitment

  5. Lung perfusion

    Time frame: 20 minutes

    Changes in lung perfusion during the apnea phase (%)

Sponsors and collaborators

Lead sponsor

Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged

Other Gov

Collaborators

  • Budapest University of Technology and Economics
  • Hochschule Furtwangen University
  • Szeged University

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 23, 2021
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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