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

• Sponsor: MemorialCare Health System (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02503813
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• 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: Jul 1, 2015
• Anticipated Primary Completion Date: Jul 1, 2017
• Anticipated Study Completion Date: Jul 1, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in venous blood CO2 during apnea challenge test [During apnea challenge test]

Secondary Outcome Measures

1. Change in End Tidal CO2 during apnea challenge test [During apnea challenge test]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Week and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Long Beach Memorial and Miller Children's & Women's Hospital Long Beach	Long Beach	California	United States	90806

Sponsors and Collaborators

• MemorialCare Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alireza Fathi, MD, Director of Critical Care Transport, Assoicate Medical Director, PICU, MemorialCare Health System
• ClinicalTrials.gov Identifier: NCT02503813
• Other Study ID Numbers: 504-15
• First Posted: Jul 21, 2015
• Last Update Posted: Jul 21, 2015
• Last Verified: Jul 1, 2015

• Keywords provided by Alireza Fathi, MD, Director of Critical Care Transport, Assoicate Medical Director, PICU, MemorialCare Health System: brain death; apnea challenge test
• Additional relevant MeSH terms: Brain Death

Study Results

No Results Posted as of Jul 21, 2015