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

Not Applicable

Completed

• Conditions: Brain Death
• Interventions: Procedure: venous blood gas

• Registration Number: NCT02503813
• Lead Sponsor: MemorialCare Health System

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-07
• Study Start: 2015-07
• Study First Submitted: 2015-07-16
• Study First Submitted QC: 2015-07-17
• Study First Posted: 2015-07-21
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	venous blood gas	Venous blood gas will be obtained at the same time points as arterial blood gas in the apnea challenge test.

Primary Outcome Measures

Name	Time	Method
Change in venous blood CO2 during apnea challenge test	During apnea challenge test

Secondary Outcome Measures

Name	Time	Method
Change in End Tidal CO2 during apnea challenge test	During apnea challenge test

Trial Locations

Locations (1)

Long Beach Memorial and Miller Children's & Women's Hospital Long Beach; 🇺🇸 Long Beach, California, United States