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

Brain Death Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02503813
• Other study ID #: 504-15
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: September 2017

Study information

• Verified date: July 2015
• Source: MemorialCare Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Week and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Death

Intervention

Procedure:
• venous blood gas
Venous blood gas will be measured at the time of arterial blood gas measurement.

Locations

Country	Name	City	State
United States	Long Beach Memorial and Miller Children's & Women's Hospital Long Beach	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
MemorialCare Health System

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fathi A, Lake JL. Use of Venous Pco(2) 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in venous blood CO2 during apnea challenge test		During apnea challenge test
Secondary	Change in End Tidal CO2 during apnea challenge test		During apnea challenge test