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CompletedNCT02503813Updated Oct 3, 2022

Does Venous pCO2 Increase by 20 mmHg or More During Apnea Challenge Test?

An interventional study of venous blood gas in Brain Death, sponsored by MemorialCare Health System. Completed at 1 site in United States. Open to participants aged 1 Week and older. Per ClinicalTrials.gov, last updated 2022-10-03.

Sponsored by MemorialCare Health System · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
1 Week and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Brain Death

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Keywords

  • brain death
  • apnea challenge test
03

In context

Brain Death

74 studies on the registry are indexed under Brain Death; 10 are open to participants now.

This study's enrollment of 7 is below the median of 154 across 39 interventional studies indexed under Brain Death.

Browse Brain Death studies →

Lead sponsor

MemorialCare Health System is the lead sponsor of 21 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Week and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age > 37 weeks gestation up to any adult age
  2. Patients admitted to Pediatric Intensive Care unit (PICU), Neonatal Intensive Care Unit (NICU), Medical Intensive Care Unit (MICU) and Cardiothoracic Intensive Care Unit (CTICU)
  3. Patients with irreversible brain injury where the attending physician will be performing death by neurological criteria examination as per hospital policy
  4. Presence of arterial catheter or arterial blood sampling during apnea challenge test
  5. Presence of central venous catheter or easily drawing peripheral intravenous catheter

Exclusion criteria

Exclusion Criteria:

  1. Age less or equal to 37 weeks gestation
  2. Inability to perform apnea challenge test as determined by primary physician
  3. Family request for Donation after Cardiac Death (DCD) or withdrawal of Life Sustaining Therapy
  4. Bicarbonate infusion within 30 minutes of apnea challenge test
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Experimental

    Venous blood gas will be obtained at the same time points as arterial blood gas in the apnea challenge test.

    Procedure: venous blood gas

Interventions

  • Procedurevenous blood gas

    Venous blood gas will be measured at the time of arterial blood gas measurement.

06

What researchers measure

Primary outcomes

  1. Change in venous blood CO2 during apnea challenge test

    Time frame: During apnea challenge test

Secondary outcomes

  1. Change in End Tidal CO2 during apnea challenge test

    Time frame: During apnea challenge test

07

Study locations

1 site
  • Long Beach Memorial and Miller Children's & Women's Hospital Long Beach
    Long Beach, California 90806, United States
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2015 to primary completion in Sep 2017, 26 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 26 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 16, 2015
First posted
Jul 21, 2015
StartActual
Jul 2015
Primary completionActual
Sep 2017
CompletionActual
Sep 2017
Last update
Oct 3, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02503813
Lead sponsor
MemorialCare Health System
Responsible party
Alireza Fathi, MD (Director of Critical Care Transport, Assoicate Medical Director, PICU, MemorialCare Health System) — Principal investigator
First posted
Jul 21, 2015
Start date
Jul 2015
Primary completion
Sep 2017
Completion
Sep 2017
Last update
Oct 3, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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