Brain DeathDiagBDNCT03281993
Apnea Tests as the Methods of Brain Death Diagnosis.
An observational study of Brain Death and Apnea, run by Pomeranian Medical University Szczecin.
Trial summary
Apnea test (AT) is the most important clinical test performed usually at the end of brain death (BD) diagnosis procedure. Traditional insufflation apnea test (I-AT) cannot be completed in patients with extremely compromised lung function due to rapid blood desaturation and circulatory disturbances. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Death, Apnea, Pupillary Anomaly
- What is being tested?
- CPAP AT
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2015to 25 Jun 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intubated adult ICU patients at the Intensive Care Unit of the Department of Anaesthesia and Intensive Care teaching hospital at the Pomeranian Medical University in Szczecin during Brain Death diagnosis
Who may be able to join
- brain death diagnosis
Who cannot join
- no
About this study
Official title: Alternative Apnea Test as the Method of Brain Death Diagnosis .
Apnea test (AT) is the most important clinical test performed usually at the end of brain death (BD) diagnosis procedure. Traditional insufflation apnea test (I-AT) cannot be completed in patients with extremely compromised lung function due to rapid blood desaturation and circulatory disturbances. Therefore the investigators decided to verify alternative AT options such as continuous positive airway pressure apnea test (CPAP-AT) in patients with good and poor baseline oxygenation, before implementing them in currently reviewed Polish BD criteria.
Read the detailed description
Apnea test (AT) is one of the most important examination during the diagnosis of brain death. It is usually performed at the end of each series of clinical examinations during diagnostic process. The most popular standard insufflation apnea test (I-AT) may be potentially harmful. It may cause some serious complications including pneumothorax, severe hypoxemia, hemodynamic instability and even cardiac arrest. Therefore, the investigators decided to analyze apnea test in CPAP option (CPAP-AT) as a new tool. For safety of the study the investigators analyzed a method after BD diagnosis.
Methods:
I-AT and hypoventilation with 100 % oxygen (if needed) were performed according to Polish guidelines. Two hours after BD diagnosis was performed extra apnea test in CPAP option (CPAP-AT). Before CPAP-AT the patients were ventilated 100% oxygen. After then the ventilator settings were changed to CPAP mode with PEEP 10 cm H2O, PS 0 cm H2O, FiO2 1,0, flow 6L/min. Emergency apnea ventilation was turned off. At the beginning of CPAP mode and 10 minutes after, blood samples for arterial blood gases (ABG) were collected. If were observed rapid desaturation defined as a decline in O2 saturation below 85%, CPAP-AT was aborted and study was finished.
During routine diagnosis of brain death, pupillary dilation after a neck flexion was observed in one case. Therefore, the investigators decided to use a pupillometer during brain death examination to find out how pupils react after a neck flexion and how often it happens.
Pupil measurements were taken immediately after the diagnosis of brain death. The measurements of pupil diameter were taken twice: A - before neck flexion; B - after neck flexion. We used pupillometer: AlgiScan (Equip Medkey BV).
- Conditions
- Brain Death, Apnea, Pupillary Anomaly
- Being tested
- CPAP AT
- Keywords
- apnea test, brain death, pupillometry
- Medical subject headings
- Brain Death, Apnea, Pupil Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP ATOther
Also called change type of ventylation
If the investigators observe rapid desaturation defined as a decline in O2 saturation below 85%; the CPAP apnea test (CPAP-AT) test was aborted.
| Study group | Role | What they receive |
|---|---|---|
| CPAP-AT | After 2 hours from I-AT was performed the alternative AT by CPAP ventilation mode. Before CPAP-AT and 10 minutes after blood samples for arterial blood gases (ABG) were collected. If the investigators observe rapid desaturation defined as a decline in O2 saturation below 85%, CPAP-AT was aborterd. Receives: Other: CPAP AT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline arterial blood gases (ABG) during CPAP-AT
After 2 hours from I-AT was performed the alternative AT by CPAP ventilation mode. Before CPAP-AT the patients were ventilated 100% oxygen. After then the ventilator parameters were modified to: 0 H2O of pressure support (PS), 10 cm H2O of PEEP, 6l/min of O2 flow and 0.2 l/min of sensitivity. Before the test and 10 minutes after then was taken blood probe to ABG and type of ventilation change to pretest settings. The test is considered valid if there is no respiratory activity despite the rise of PaCO2 above 60mmHg and over 20mmHg above the baseline. If the investigators observe rapid desaturation defined as a decline in O2 saturation below 85%, CPAP-AT was aborterd.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start25 Jun 2015
- Primary completion25 Jun 2015
- Study completion25 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanna Sołek-Pastuszka, Pomeranian Medical University Szczecin
- Investigators
- Joanna Pastuszka, MD PhD, Principal investigator, Pomeranian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281993
- Sponsor's protocol ID
- KB-0012/116/13
- Acronym
- DiagBD
- Status last verified
- Sep 2017
- First submitted
- 3 Sep 2017
- Last updated
- 14 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Solek-Pastuszka J, Sawicki M, Iwanczuk W, Bohatyrewicz R. Ventilator-Delivered Continuous Positive Airway Pressure for Apnea Test in the Diagnosis of Brain Death in Patient With Extremely Poor Baseline Lung Function-Case Report. Transplant Proc. 2016 Sep;48(7):2471-2472. doi: 10.1016/j.transproceed.2016.02.089.
PubMed 27742325Saucha W, Solek-Pastuszka J, Bohatyrewicz R, Knapik P. Apnea test in the determination of brain death in patients treated with extracorporeal membrane oxygenation (ECMO). Anaesthesiol Intensive Ther. 2015;47(4):368-71. doi: 10.5603/AIT.2015.0051.
PubMed 26401745Solek-Pastuszka J, Saucha W, Iwanczuk W, Bohatyrewicz R. Evolution of apnoea test in brain death diagnostics. Anaesthesiol Intensive Ther. 2015;47(4):363-7. doi: 10.5603/AIT.2015.0050.
PubMed 26401744
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternative Apnea Test as the Method of Brain Death Diagnosis .
- ClinicalTrials.gov ID
- NCT03281993
- Acronym / sponsor ID
- DiagBD / KB-0012/116/13
- Conditions
- Brain Death, Apnea, Pupillary Anomaly
- Keywords
- apnea test, brain death, pupillometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 25 Jun 2015 (actual)
- Primary completion
- 25 Jun 2015 (actual)
- Study completion
- 25 Jun 2017 (actual)
- First posted
- 13 Sep 2017 (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 test (AT) is the most important clinical test performed usually at the end of brain death (BD) diagnosis procedure. Traditional insufflation apnea test (I-AT) cannot be completed in patients with extremely compromised lung function due to rapid blood desaturation and circulatory disturbances. Therefore the investigators decided to verify alternative AT options such as continuous positive airway pressure apnea test (CPAP-AT) in patients with good and poor baseline oxygenation, before implementing them in currently reviewed Polish BD criteria.
Detailed description
Apnea test (AT) is one of the most important examination during the diagnosis of brain death. It is usually performed at the end of each series of clinical examinations during diagnostic process. The most popular standard insufflation apnea test (I-AT) may be potentially harmful. It may cause some serious complications including pneumothorax, severe hypoxemia, hemodynamic instability and even cardiac arrest. Therefore, the investigators decided to analyze apnea test in CPAP option (CPAP-AT) as a new tool. For safety of the study the investigators analyzed a method after BD diagnosis.
Methods:
I-AT and hypoventilation with 100 % oxygen (if needed) were performed according to Polish guidelines. Two hours after BD diagnosis was performed extra apnea test in CPAP option (CPAP-AT). Before CPAP-AT the patients were ventilated 100% oxygen. After then the ventilator settings were changed to CPAP mode with PEEP 10 cm H2O, PS 0 cm H2O, FiO2 1,0, flow 6L/min. Emergency apnea ventilation was turned off. At the beginning of CPAP mode and 10 minutes after, blood samples for arterial blood gases (ABG) were collected. If were observed rapid desaturation defined as a decline in O2 saturation below 85%, CPAP-AT was aborted and study was finished.
During routine diagnosis of brain death, pupillary dilation after a neck flexion was observed in one case. Therefore, the investigators decided to use a pupillometer during brain death examination to find out how pupils react after a neck flexion and how often it happens.
Pupil measurements were taken immediately after the diagnosis of brain death. The measurements of pupil diameter were taken twice: A - before neck flexion; B - after neck flexion. We used pupillometer: AlgiScan (Equip Medkey BV).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPAP-AT | – | Other: CPAP ATAfter 2 hours from I-AT was performed the alternative AT by CPAP ventilation mode. Before CPAP-AT and 10 minutes after blood samples for arterial blood gases (ABG) were collected. If the investigators observe rapid desaturation defined as a decline in O2 saturation below 85%, CPAP-AT was aborterd. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intubated adult ICU patients at the Intensive Care Unit of the Department of Anaesthesia and Intensive Care teaching hospital at the Pomeranian Medical University in Szczecin during Brain Death diagnosis
Key inclusion criteria (1 listed)
- brain death diagnosis
Key exclusion criteria (1 listed)
- no
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 |
|---|---|---|
| CPAP ATAlso: change type of ventylationIf the investigators observe rapid desaturation defined as a decline in O2 saturation below 85%; the CPAP apnea test (CPAP-AT) test was aborted. | Other | CPAP-AT |
Primary outcome
Change from baseline arterial blood gases (ABG) during CPAP-AT
Time frame: 10 minutes
After 2 hours from I-AT was performed the alternative AT by CPAP ventilation mode. Before CPAP-AT the patients were ventilated 100% oxygen. After then the ventilator parameters were modified to: 0 H2O of pressure support (PS), 10 cm H2O of PEEP, 6l/min of O2 flow and 0.2 l/min of sensitivity. Before the test and 10 minutes after then was taken blood probe to ABG and type of ventilation change to pretest settings. The test is considered valid if there is no respiratory activity despite the rise of PaCO2 above 60mmHg and over 20mmHg above the baseline. If the investigators observe rapid desaturation defined as a decline in O2 saturation below 85%, CPAP-AT was aborterd.
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 14 Sep 2017.
- Background: PubMed 27742325Solek-Pastuszka J, Sawicki M, Iwanczuk W, Bohatyrewicz R. Ventilator-Delivered Continuous Positive Airway Pressure for Apnea Test in the Diagnosis of Brain Death in Patient With Extremely Poor Baseline Lung Function-Case Report. Transplant Proc. 2016 Sep;48(7):2471-2472. doi: 10.1016/j.transproceed.2016.02.089.
- Background: PubMed 26401745Saucha W, Solek-Pastuszka J, Bohatyrewicz R, Knapik P. Apnea test in the determination of brain death in patients treated with extracorporeal membrane oxygenation (ECMO). Anaesthesiol Intensive Ther. 2015;47(4):368-71. doi: 10.5603/AIT.2015.0051.
- Background: PubMed 26401744Solek-Pastuszka J, Saucha W, Iwanczuk W, Bohatyrewicz R. Evolution of apnoea test in brain death diagnostics. Anaesthesiol Intensive Ther. 2015;47(4):363-7. doi: 10.5603/AIT.2015.0050.
- 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.
Joanna Pastuszka, MD PhD principal investigator
Pomeranian Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Death and Apnea, run by Pomeranian Medical University Szczecin.
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 1 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 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline arterial blood gases (ABG) during CPAP-AT (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03281993, which also lists 3 linked publications.
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 14 Sep 2017.