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Trial record 52 of 668 for:    CARBON DIOXIDE AND arterial

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

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ClinicalTrials.gov Identifier: NCT02503813
Recruitment Status : Unknown
Verified July 2015 by Alireza Fathi, MD, MemorialCare Health System.
Recruitment status was:  Recruiting
First Posted : July 21, 2015
Last Update Posted : July 21, 2015
Sponsor:
Information provided by (Responsible Party):
Alireza Fathi, MD, 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.

Condition or disease Intervention/treatment Phase
Brain Death Procedure: venous blood gas Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Does Venous pCO2 Increase by 20 mmHg or More During Apnea Challenge Test?
Study Start Date : July 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

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.




Primary Outcome Measures :
  1. Change in venous blood CO2 during apnea challenge test [ Time Frame: During apnea challenge test ]

Secondary Outcome Measures :
  1. Change in End Tidal CO2 during apnea challenge test [ Time Frame: During apnea challenge test ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503813


Contacts
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Contact: Dena Freeman, MPH 562-933-1713 dfreeman2@memorialcare.org

Locations
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United States, California
Long Beach Memorial and Miller Children's & Women's Hospital Long Beach Recruiting
Long Beach, California, United States, 90806
Contact: Dena Freeman, MPH    562-933-1713    dfreeman2@memorialcare.org   
Principal Investigator: Alireza Fathi, MD, MBA         
Sub-Investigator: Jean Lake, MD         
Sub-Investigator: Maged Tanios, MD, MPH         
Sponsors and Collaborators
MemorialCare Health System

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Responsible Party: Alireza Fathi, MD, Director of Critical Care Transport, Assoicate Medical Director, PICU, MemorialCare Health System
ClinicalTrials.gov Identifier: NCT02503813     History of Changes
Other Study ID Numbers: 504-15
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015
Keywords provided by Alireza Fathi, MD, MemorialCare Health System:
brain death
apnea challenge test
Additional relevant MeSH terms:
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Brain Death
Death
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations