Does Venous pCO2 Increase by 20 mmHg or More During Apnea Challenge Test?
Primary Purpose
Brain Death
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
venous blood gas
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Death focused on measuring brain death, apnea challenge test
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Long Beach Memorial and Miller Children's & Women's Hospital Long Beach
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Venous blood gas will be obtained at the same time points as arterial blood gas in the apnea challenge test.
Outcomes
Primary Outcome Measures
Change in venous blood CO2 during apnea challenge test
Secondary Outcome Measures
Change in End Tidal CO2 during apnea challenge test
Full Information
NCT ID
NCT02503813
First Posted
July 16, 2015
Last Updated
September 29, 2022
Sponsor
MemorialCare Health System
1. Study Identification
Unique Protocol Identification Number
NCT02503813
Brief Title
Does Venous pCO2 Increase by 20 mmHg or More During Apnea Challenge Test?
Official Title
Does Venous pCO2 Increase by 20 mmHg or More During Apnea Challenge Test?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MemorialCare Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Death
Keywords
brain death, apnea challenge test
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Venous blood gas will be obtained at the same time points as arterial blood gas in the apnea challenge test.
Intervention Type
Procedure
Intervention Name(s)
venous blood gas
Intervention Description
Venous blood gas will be measured at the time of arterial blood gas measurement.
Primary Outcome Measure Information:
Title
Change in venous blood CO2 during apnea challenge test
Time Frame
During apnea challenge test
Secondary Outcome Measure Information:
Title
Change in End Tidal CO2 during apnea challenge test
Time Frame
During apnea challenge test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Week
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Long Beach Memorial and Miller Children's & Women's Hospital Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30704867
Citation
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.
Results Reference
result
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Does Venous pCO2 Increase by 20 mmHg or More During Apnea Challenge Test?
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