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Completed

NCT Number: NCT02503813

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

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.

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Key information

Conditions

Brain Death Brain Diseases Central Nervous System Diseases Coma Consciousness Disorders Death Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Unconsciousness

Age range

1 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Long Beach Memorial and Miller Children's & Women's Hospital Long Beach

Long Beach, California, 90806, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

venous blood gas

Procedure

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

Primary outcomes

  1. Change in venous blood CO2 during apnea challenge test

    Time frame: During apnea challenge test

Secondary outcomes

  1. Change in End Tidal CO2 during apnea challenge test

    Time frame: During apnea challenge test

Sponsors and collaborators

Lead sponsor

MemorialCare Health System

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 21, 2015
Registry last updated
Oct 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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