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

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ClinicalTrials.gov Identifier: NCT04857242
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : February 15, 2022
Sponsor:
Collaborators:
Budapest University of Technology and Economics
Hochschule Furtwangen University
Information provided by (Responsible Party):
Szeged University

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Brain Death Diagnostic Test: Apnea test, alveolar recruitment Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Electrical Impedance Tomography Measurements During Apnea Test in Patients With Suspected Brain Death
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: apnea test, recruitment manoeuvre
  1. Continuous electric impedance tomography (EIT) recording. Recording of initial vital parameters and arterial blood gas results. Adjusment of PaCO2 between 38-42 mmHg, 10 minutes of preoxygenation with FiO2 of 1.0 then disconnection of the patient from the ventilator.
  2. Continuous administration of 6 L/min O2 flow via a catheter into the tracheal tube.
  3. Arterial blood gas sampling and recording of vital parameters in every second minutes. Detection of any spontaneous respiratory movement by the apnoe test investigator or by EIT signals.
  4. Reconnection with respirator if there is any sign of spontaneous breathing effort or if there is no spontaneous breathing effort and the PaCO2 is over 60 mmHg. Recording of vital parameters.
  5. Recruitment manoeuvre (PEEP 20 cmH2O, pressure control 20 cmH20 for 40 minutes) then set up of the initial ventilator parameters.
  6. Terminal arterial blood gas results and vital parameters 5 minutes following the end of the recruitment manoeuvre.
 Diagnostic Test: Apnea test, alveolar recruitment
Alveolar recruitment following the phase of apnea testing


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 (%)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04857242


Contacts
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Contact: András Lovas, MD, PhD +36 77 522000 ext 2045 landras@halasi-korhaz.hu

Locations
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Hungary
University of Szeged Recruiting
Szeged, Hungary, 6725
Contact: Péter Bakos, MD         
Principal Investigator: Péter Bakos, MD         
Sponsors and Collaborators
Szeged University
Budapest University of Technology and Economics
Hochschule Furtwangen University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Szeged University
ClinicalTrials.gov Identifier: NCT04857242    
Other Study ID Numbers: apnEIT
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: February 15, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Szeged University:
Apnea testing
Electrical Impedance Tomography
Additional relevant MeSH terms:
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Brain Death
Death
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations