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NCT04857242 Clinical Trial

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

Brain Death Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04857242
Other study ID # apnEIT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date April 13, 2023

Study information
Verified date February 2024
Source Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date April 13, 2023
Est. primary completion date April 13, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Apnea test, alveolar recruitment
Alveolar recruitment following the phase of apnea testing

Locations
Country Name City State
Hungary University of Szeged Szeged

Sponsors (4)
Lead Sponsor Collaborator
Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged Budapest University of Technology and Economics, Hochschule Furtwangen University, Szeged University

Country where clinical trial is conducted

Hungary, 

Outcome
Type Measure Description Time frame Safety issue
Primary detection of spontaneous inspiration Detection of absolute changes in impedance using EIT during apnea test, which may refer to spontaneous initiations of inspiration 20 minutes
Secondary Gas exchange Change in arterial partial pressure of oxygen (PaO2) (mmHg) following alveolar recruitment performed after apnea testing 20 minutes
Secondary Dynamic compliance Change in dynamic compliance (ml/cmH2O) following alveolar recruitment 20 minutes
Secondary End expiratory lung impedance Change in end expiratory lung impedance (EELI) (%) following alveolar recruitment 20 minutes
Secondary Center of ventilation Change in center of ventilation (%) following alveolar recruitment 20 minutes
Secondary Lung perfusion Changes in lung perfusion during the apnea phase (%) 20 minutes
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