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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02503813

Enrollment

Registered

2015-07-21

Start date

2015-07-31

Completion date

2017-09-30

Last updated

2022-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Death

Keywords

brain death, apnea challenge test

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.

Interventions

PROCEDUREvenous blood gas

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Weeks to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in venous blood CO2 during apnea challenge test	During apnea challenge test

Secondary

Measure	Time frame
Change in End Tidal CO2 during apnea challenge test	During apnea challenge test

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026