An interventional study of Apnea test, alveolar recruitment in Brain Death, sponsored by Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged. Completed at 1 site in Hungary. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged · Not applicable, Interventional, and Diagnostic
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.
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.
74 studies on the registry are indexed under Brain Death; 10 are open to participants now.
This study's enrollment of 10 is below the median of 154 across 39 interventional studies indexed under Brain Death.
Browse Brain Death studies →Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
detection of spontaneous inspiration
Detection of absolute changes in impedance using EIT during apnea test, which may refer to spontaneous initiations of inspiration
Time frame: 20 minutes
Gas exchange
Change in arterial partial pressure of oxygen (PaO2) (mmHg) following alveolar recruitment performed after apnea testing
Time frame: 20 minutes
Dynamic compliance
Change in dynamic compliance (ml/cmH2O) following alveolar recruitment
Time frame: 20 minutes
End expiratory lung impedance
Change in end expiratory lung impedance (EELI) (%) following alveolar recruitment
Time frame: 20 minutes
Center of ventilation
Change in center of ventilation (%) following alveolar recruitment
Time frame: 20 minutes
Lung perfusion
Changes in lung perfusion during the apnea phase (%)
Time frame: 20 minutes
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2021 to primary completion in Apr 2023, 24 months.
Of 14 interventional studies with no phase under Brain Death, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 52. This study's 24 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged