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

September 29, 2022 updated by: Alireza Fathi, MD, MemorialCare Health System
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90806
        • Long Beach Memorial and Miller Children's & Women's Hospital Long Beach

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Venous blood gas will be measured at the time of arterial blood gas measurement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in venous blood CO2 during apnea challenge test
Time Frame: During apnea challenge test
During apnea challenge test

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in End Tidal CO2 during apnea challenge test
Time Frame: During apnea challenge test
During apnea challenge test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MemorialCare Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

July 16, 2015

First Submitted That Met QC Criteria

July 17, 2015

First Posted (Estimate)

July 21, 2015

Study Record Updates

Last Update Posted (Actual)

October 3, 2022

Last Update Submitted That Met QC Criteria

September 29, 2022

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 504-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Brain Death

Clinical Trials on venous blood gas

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe