Clinical trial NCT02503813: 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
Overall status: COMPLETED
Phase: NA
Conditions: Brain Death
Keywords: brain death
apnea challenge test
Lead sponsor: MemorialCare Health System
Sponsor class: OTHER
First posted: 2015-07-21
Enrollment: 7
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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:

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

Primary outcomes:
measure: Change in venous blood CO2 during apnea challenge test
timeFrame: During apnea challenge test
Secondary outcomes:
measure: Change in End Tidal CO2 during apnea challenge test
timeFrame: During apnea challenge test
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Long Beach Memorial and Miller Children's & Women's Hospital Long Beach
state: California
Study officials:
References:
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.