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

NCT02503813 | Completed

• 1 other identifier: 504-15
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Death

Keywords

brain death; apnea challenge test

Outcome Measures

Primary Outcomes (1)

• Change in venous blood CO2 during apnea challenge test

  During apnea challenge test

Secondary Outcomes (1)

• Change in End Tidal CO2 during apnea challenge test

  During apnea challenge test

Study Arms (1)

Experimental

EXPERIMENTAL

Venous blood gas will be obtained at the same time points as arterial blood gas in the apnea challenge test.

Procedure: venous blood gas

Interventions

venous blood gas PROCEDURE

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

Experimental

Eligibility Criteria

• Age: 1 Week+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MemorialCare Health System: lead

Study Sites (1)

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

Long Beach, California, 90806, United States

Location

Related Publications (1)

• 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.

  PMID: 30704867 RESULT

MeSH Terms

Conditions

Brain Death

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Critical Care Transport, Assoicate Medical Director, PICU

Study Record Dates

• First Submitted: July 16, 2015
• First Posted: July 21, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 3, 2022

Record last verified: 2015-07

Locations

US (1)