Brain DeathNCT04857242
Electrical Impedance Tomography Measurements During Apnea Test in Patients With Suspected Brain Death
A study testing Apnea test, alveolar recruitment in people with Brain Death, run by Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged at 1 site in Hungary.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Brain Death
- What is being tested?
- Apnea test, alveolar recruitment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteHungary
- Study dates
- 1 Apr 2021to 13 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with suspected brain death undergoing apnea test for detecting the absence of spontaneous breathing
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Brain Death
- Being tested
- Apnea test, alveolar recruitment
- Keywords
- Apnea testing, Electrical Impedance Tomography
- Medical subject headings
- Brain Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apnea test, alveolar recruitmentDiagnostic test
Alveolar recruitment following the phase of apnea testing
| Study group | Role | What they receive |
|---|---|---|
| apnea test, recruitment manoeuvre | Experimental | 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. Receives: Diagnostic Test: Apnea test, alveolar recruitment |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of spontaneous inspiration
Detection of absolute changes in impedance using EIT during apnea test, which may refer to spontaneous initiations of inspiration
Measured: 20 minutes
Secondary outcomes (5)
Gas exchange
Change in arterial partial pressure of oxygen (PaO2) (mmHg) following alveolar recruitment performed after apnea testing
Measured: 20 minutes
Dynamic compliance
Change in dynamic compliance (ml/cmH2O) following alveolar recruitment
Measured: 20 minutes
End expiratory lung impedance
Change in end expiratory lung impedance (EELI) (%) following alveolar recruitment
Measured: 20 minutes
Center of ventilation
Change in center of ventilation (%) following alveolar recruitment
Measured: 20 minutes
Lung perfusion
Changes in lung perfusion during the apnea phase (%)
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start1 Apr 2021
- Primary completion13 Apr 2023
- Study completion13 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged
- Sponsor type
- Other government
- Collaborators
- Budapest University of Technology and Economics, Hochschule Furtwangen University, Szeged University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857242
- Sponsor's protocol ID
- apnEIT
- Status last verified
- Feb 2024
- First submitted
- 22 Apr 2021
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Impedance Tomography Measurements During Apnea Test in Patients With Suspected Brain Death
- ClinicalTrials.gov ID
- NCT04857242
- Acronym / sponsor ID
- apnEIT
- Conditions
- Brain Death
- Keywords
- Apnea testing, Electrical Impedance Tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of SzegedOther government
- Collaborators
- Budapest University of Technology and Economics, Hochschule Furtwangen University, Szeged University
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 13 Apr 2023 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| apnea test, recruitment manoeuvre | Experimental | Diagnostic Test: Apnea test, alveolar recruitment1. 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with suspected brain death undergoing apnea test for detecting the absence of spontaneous breathing
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apnea test, alveolar recruitmentAlveolar recruitment following the phase of apnea testing | Diagnostic test | apnea test, recruitment manoeuvre |
Primary outcome
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
5 secondary outcomes
Gas exchange
Time frame: 20 minutes
Dynamic compliance
Time frame: 20 minutes
End expiratory lung impedance
Time frame: 20 minutes
Center of ventilation
Time frame: 20 minutes
Lung perfusion
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apnea test, alveolar recruitment in people with Brain Death, run by Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection of spontaneous inspiration (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.