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

NCT ID: NCT02503813

Last Updated: 2022-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-09-30

Brief Summary

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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

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Conditions

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Brain Death

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Experimental

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

Group Type EXPERIMENTAL

venous blood gas

Intervention Type PROCEDURE

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

Interventions

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venous blood gas

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

1 Week

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MemorialCare Health System

OTHER

Sponsor Role lead

Responsible Party

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Alireza Fathi, MD

Director of Critical Care Transport, Assoicate Medical Director, PICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Long Beach, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 30704867 (View on PubMed)

Other Identifiers

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504-15

Identifier Type: -

Identifier Source: org_study_id

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