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

Primary Purpose

Brain Death

Status
Recruiting
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Apnea test, alveolar recruitment
Sponsored by
Szeged University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Death focused on measuring Apnea testing, Electrical Impedance Tomography

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of SzegedRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

apnea test, recruitment manoeuvre

Arm Description

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. Continuous administration of 6 L/min O2 flow via a catheter into the tracheal tube. 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. 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. Recruitment manoeuvre (PEEP 20 cmH2O, pressure control 20 cmH20 for 40 minutes) then set up of the initial ventilator parameters. Terminal arterial blood gas results and vital parameters 5 minutes following the end of the recruitment manoeuvre.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Gas exchange
Change in arterial partial pressure of oxygen (PaO2) (mmHg) following alveolar recruitment performed after apnea testing
Dynamic compliance
Change in dynamic compliance (ml/cmH2O) following alveolar recruitment
End expiratory lung impedance
Change in end expiratory lung impedance (EELI) (%) following alveolar recruitment
Center of ventilation
Change in center of ventilation (%) following alveolar recruitment
Lung perfusion
Changes in lung perfusion during the apnea phase (%)

Full Information

First Posted
April 22, 2021
Last Updated
February 11, 2022
Sponsor
Szeged University
Collaborators
Budapest University of Technology and Economics, Hochschule Furtwangen University
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1. Study Identification

Unique Protocol Identification Number
NCT04857242
Brief Title
Electrical Impedance Tomography Measurements During Apnea Test in Patients With Suspected Brain Death
Official Title
Electrical Impedance Tomography Measurements During Apnea Test in Patients With Suspected Brain Death
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Szeged University
Collaborators
Budapest University of Technology and Economics, Hochschule Furtwangen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Death
Keywords
Apnea testing, Electrical Impedance Tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
apnea test, recruitment manoeuvre
Arm Type
Experimental
Arm Description
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. Continuous administration of 6 L/min O2 flow via a catheter into the tracheal tube. 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. 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. Recruitment manoeuvre (PEEP 20 cmH2O, pressure control 20 cmH20 for 40 minutes) then set up of the initial ventilator parameters. Terminal arterial blood gas results and vital parameters 5 minutes following the end of the recruitment manoeuvre.
Intervention Type
Diagnostic Test
Intervention Name(s)
Apnea test, alveolar recruitment
Intervention Description
Alveolar recruitment following the phase of apnea testing
Primary Outcome Measure Information:
Title
detection of spontaneous inspiration
Description
Detection of absolute changes in impedance using EIT during apnea test, which may refer to spontaneous initiations of inspiration
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Gas exchange
Description
Change in arterial partial pressure of oxygen (PaO2) (mmHg) following alveolar recruitment performed after apnea testing
Time Frame
20 minutes
Title
Dynamic compliance
Description
Change in dynamic compliance (ml/cmH2O) following alveolar recruitment
Time Frame
20 minutes
Title
End expiratory lung impedance
Description
Change in end expiratory lung impedance (EELI) (%) following alveolar recruitment
Time Frame
20 minutes
Title
Center of ventilation
Description
Change in center of ventilation (%) following alveolar recruitment
Time Frame
20 minutes
Title
Lung perfusion
Description
Changes in lung perfusion during the apnea phase (%)
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
András Lovas, MD, PhD
Phone
+36 77 522000
Ext
2045
Email
landras@halasi-korhaz.hu
Facility Information:
Facility Name
University of Szeged
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Péter Bakos, MD
First Name & Middle Initial & Last Name & Degree
Péter Bakos, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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