Brain DeathNCT06359119
Implementation of Apnoea Test for Patients With Suspected Brain Death
An observational study of Brain Death, run by Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged.
Trial summary
This study consists of a survey created for intensive care physicians regarding their current practice of the implementation of apnoea test for patients with suspected brain death. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Brain Death
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 31 Jul 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Any physician working in intensive care can fill the form and participate in the study.
Who may be able to join
- Physicians working in intensive care units
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Implementation of Apnoea Test for Patients With Suspected Brain Death (IMAPing SUBDEP)
This study consists of a survey created for intensive care physicians regarding their current practice of the implementation of apnoea test for patients with suspected brain death.
Read the detailed description
Although the apnoea test is part of nearly all protocols for determining brain death; implementation significantly differs among intensive care physicians according to national-level acts, national society protocols or local protocols.
This cross-sectional study is based on an international, web-based questionnaire created for intensive care physicians, consisting of 25 questions in English.
The survey will provide a current state of the practice of apnoea testing in patients with suspected brain death. The results can support the determination of future acts to standardize the apnoea test process.
The given answers are anonymous. The e-mail address of the respondent is not recorded. Answers are treated solely for scientific purposes.
- Conditions
- Brain Death
- Keywords
- brain death determination, apnoea test, survey
- Medical subject headings
- Brain Death
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of apnoea tests
How much apnoea test is required for brain death determination.
Measured: last 1 year
Timeframe between apnoea tests
If more than 1 apnoeae test is reuired for brain death determination, how many hours should elapse between the two tests.
Measured: last 1 year
Preoxygenation
For how long (in minutes) the patient is preoxygenated before the apnoea test.
Measured: last 1 year
Baseline arterial carbon dioxide (CO2) level
What is the required arterial partial CO2 pressure (PaCO2) before apnoea testing, confirmed by arterial blood gas measurement?
Measured: Last 1 year
Secondary outcomes (2)
Detection of possible spontaneous breath movements
To determine if any observation method other than visualisation by the observer is used to determine possible spontaneous breath movements during the apnoea test.
Measured: last 1 year
Satisfaction with current practice
Surveying the satisfaction of physicians with current practice regarding the method of the detection of spontaneous breath movements on a 4 grade scale (1 - non-reliable to 4 - very reliable).
Measured: last 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged
- Sponsor type
- Other government
- Collaborators
- Veszprém County Ferenc Csolnoky Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359119
- Sponsor's protocol ID
- IMAPing SUBDEP
- Status last verified
- May 2024
- First submitted
- 27 Mar 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Apnoea Test for Patients With Suspected Brain Death (IMAPing SUBDEP)
- ClinicalTrials.gov ID
- NCT06359119
- Acronym / sponsor ID
- IMAPing SUBDEP
- Conditions
- Brain Death
- Keywords
- brain death determination, apnoea test, survey
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of SzegedOther government
- Collaborators
- Veszprém County Ferenc Csolnoky Hospital
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 11 Apr 2024 (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.
This study consists of a survey created for intensive care physicians regarding their current practice of the implementation of apnoea test for patients with suspected brain death.
Detailed description
Although the apnoea test is part of nearly all protocols for determining brain death; implementation significantly differs among intensive care physicians according to national-level acts, national society protocols or local protocols.
This cross-sectional study is based on an international, web-based questionnaire created for intensive care physicians, consisting of 25 questions in English.
The survey will provide a current state of the practice of apnoea testing in patients with suspected brain death. The results can support the determination of future acts to standardize the apnoea test process.
The given answers are anonymous. The e-mail address of the respondent is not recorded. Answers are treated solely for scientific purposes.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any physician working in intensive care can fill the form and participate in the study.
Key inclusion criteria (1 listed)
- Physicians working in intensive care units
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of apnoea tests
Time frame: last 1 year
How much apnoea test is required for brain death determination.
Timeframe between apnoea tests
Time frame: last 1 year
If more than 1 apnoeae test is reuired for brain death determination, how many hours should elapse between the two tests.
Preoxygenation
Time frame: last 1 year
For how long (in minutes) the patient is preoxygenated before the apnoea test.
Baseline arterial carbon dioxide (CO2) level
Time frame: Last 1 year
What is the required arterial partial CO2 pressure (PaCO2) before apnoea testing, confirmed by arterial blood gas measurement?
2 secondary outcomes
Detection of possible spontaneous breath movements
Time frame: last 1 year
Satisfaction with current practice
Time frame: last 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Death, run by Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged.
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: status not confirmed, as of the sponsor's last update on 6 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bakos Péter (+36207752886, imaping.subdep@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of apnoea tests (time frame: last 1 year). The study lists 4 primary outcomes in all. 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 6 May 2024.