Brain DeathNCT02503813
Does Venous pCO2 Increase by 20 mmHg or More During Apnea Challenge Test?
A study testing venous blood gas in people with Brain Death, run by MemorialCare Health System at 1 site in United States.
Trial summary
One required examination for declaration of death by neurological criteria is the apnea challenge test. The apnea challenge test evaluates the medulla brainstem respiratory center response to a rise in CO2. Read more about this study
- Who is it for?
- Ages 1 week and older
- Conditions the study is for
- Brain Death
- What is being tested?
- venous blood gas
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Sep 2017
- 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 1 week and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age > 37 weeks gestation up to any adult age
- Patients admitted to Pediatric Intensive Care unit (PICU), Neonatal Intensive Care Unit (NICU), Medical Intensive Care Unit (MICU) and Cardiothoracic Intensive Care Unit (CTICU)
- Patients with irreversible brain injury where the attending physician will be performing death by neurological criteria examination as per hospital policy
- Presence of arterial catheter or arterial blood sampling during apnea challenge test
- Presence of central venous catheter or easily drawing peripheral intravenous catheter
Who cannot join
- Age less or equal to 37 weeks gestation
- Inability to perform apnea challenge test as determined by primary physician
- Family request for Donation after Cardiac Death (DCD) or withdrawal of Life Sustaining Therapy
- Bicarbonate infusion within 30 minutes of apnea challenge test
Trial locations and contacts
1 site in 1 country.
United States1 site
Long Beach Memorial and Miller Children's & Women's Hospital Long Beach
Long Beach, California, 90806
About this study
One required examination for declaration of death by neurological criteria is the apnea challenge test. The apnea challenge test evaluates the medulla brainstem respiratory center response to a rise in CO2. The current guideline requires arterial sampling of CO2 and therefore either arterial puncture or arterial catheter placement for the examination. Arterial catheter is an invasive monitoring device and is not without complications. Recent studies have demonstrated that there is a direct correlation between peripheral venous and arterial blood gas measures and that peripheral venous CO2 measures may be used as alternatives to arterial CO2 measure.The purpose of this study is to evaluate brainstem response during the apnea challenge test to a rise in venous CO2 and correlate it with the rise in arterial measured CO2. The objective of this study is to demonstrate a similar rise between the venous and arterial CO2 during the apnea challenge test and eliminate the necessity of arterial blood sampling for the sole purpose of apnea challenge test in the future.
- Conditions
- Brain Death
- Being tested
- venous blood gas
- Keywords
- brain death, apnea challenge test
- Medical subject headings
- Brain Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venous blood gasProcedure or surgery
Venous blood gas will be measured at the time of arterial blood gas measurement.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Venous blood gas will be obtained at the same time points as arterial blood gas in the apnea challenge test. Receives: Procedure: venous blood gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in venous blood CO2 during apnea challenge test
Measured: During apnea challenge test
Secondary outcomes (1)
Change in End Tidal CO2 during apnea challenge test
Measured: During apnea challenge test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- MemorialCare Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alireza Fathi, MD, MemorialCare Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503813
- Sponsor's protocol ID
- 504-15
- Status last verified
- Jul 2015
- First submitted
- 16 Jul 2015
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Fathi A, Lake JL. Use of Venous Pco2 in Determination of Death by Neurological Criteria in Children. Pediatr Neurol. 2019 Apr;93:17-20. doi: 10.1016/j.pediatrneurol.2018.12.001. Epub 2018 Dec 19.
PubMed 30704867
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Venous pCO2 Increase by 20 mmHg or More During Apnea Challenge Test?
- ClinicalTrials.gov ID
- NCT02503813
- Acronym / sponsor ID
- 504-15
- Conditions
- Brain Death
- Keywords
- brain death, apnea challenge test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- MemorialCare Health SystemUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 21 Jul 2015 (estimated)
- 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.
One required examination for declaration of death by neurological criteria is the apnea challenge test. The apnea challenge test evaluates the medulla brainstem respiratory center response to a rise in CO2. The current guideline requires arterial sampling of CO2 and therefore either arterial puncture or arterial catheter placement for the examination. Arterial catheter is an invasive monitoring device and is not without complications. Recent studies have demonstrated that there is a direct correlation between peripheral venous and arterial blood gas measures and that peripheral venous CO2 measures may be used as alternatives to arterial CO2 measure.The purpose of this study is to evaluate brainstem response during the apnea challenge test to a rise in venous CO2 and correlate it with the rise in arterial measured CO2. The objective of this study is to demonstrate a similar rise between the venous and arterial CO2 during the apnea challenge test and eliminate the necessity of arterial blood sampling for the sole purpose of apnea challenge test in the future.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: venous blood gasVenous blood gas will be obtained at the same time points as arterial blood gas in the apnea challenge test. |
Who may qualify
- Ages
- 1 week and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 37 weeks gestation up to any adult age
- Patients admitted to Pediatric Intensive Care unit (PICU), Neonatal Intensive Care Unit (NICU), Medical Intensive Care Unit (MICU) and Cardiothoracic Intensive Care Unit (CTICU)
- Patients with irreversible brain injury where the attending physician will be performing death by neurological criteria examination as per hospital policy
- Presence of arterial catheter or arterial blood sampling during apnea challenge test
- Presence of central venous catheter or easily drawing peripheral intravenous catheter
Key exclusion criteria (4 listed)
- Age less or equal to 37 weeks gestation
- Inability to perform apnea challenge test as determined by primary physician
- Family request for Donation after Cardiac Death (DCD) or withdrawal of Life Sustaining Therapy
- Bicarbonate infusion within 30 minutes of apnea challenge test
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 |
|---|---|---|
| venous blood gasVenous blood gas will be measured at the time of arterial blood gas measurement. | Procedure or surgery | Experimental |
Primary outcome
Change in venous blood CO2 during apnea challenge test
Time frame: During apnea challenge test
1 secondary outcome
Change in End Tidal CO2 during apnea challenge test
Time frame: During apnea challenge test
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 3 Oct 2022.
- Results publication: PubMed 30704867Fathi A, Lake JL. Use of Venous Pco2 in Determination of Death by Neurological Criteria in Children. Pediatr Neurol. 2019 Apr;93:17-20. doi: 10.1016/j.pediatrneurol.2018.12.001. Epub 2018 Dec 19.
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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 venous blood gas in people with Brain Death, run by MemorialCare Health System at 1 site in United States.
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 5 inclusion and 4 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 3 Oct 2022. 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 United States. 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?
Change in venous blood CO2 during apnea challenge test (time frame: During apnea challenge test). 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 NCT02503813, which also lists 1 linked publication.
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 3 Oct 2022.