Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 52 of 693 for:    CARBON DIOXIDE AND arterial

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 16, 2015
First Posted Date  ICMJE July 21, 2015
Last Update Posted Date July 21, 2015
Study Start Date  ICMJE July 2015
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2015)
Change in venous blood CO2 during apnea challenge test [ Time Frame: During apnea challenge test ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2015)
Change in End Tidal CO2 during apnea challenge test [ Time Frame: During apnea challenge test ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Venous pCO2 Increase by 20 mmHg or More During Apnea Challenge Test?
Official Title  ICMJE Does Venous pCO2 Increase by 20 mmHg or More During Apnea Challenge Test?
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Brain Death
Intervention  ICMJE Procedure: venous blood gas
Venous blood gas will be measured at the time of arterial blood gas measurement.
Study Arms  ICMJE Experimental: Experimental
Venous blood gas will be obtained at the same time points as arterial blood gas in the apnea challenge test.
Intervention: Procedure: venous blood gas
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 17, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2017
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02503813
Other Study ID Numbers  ICMJE 504-15
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alireza Fathi, MD, MemorialCare Health System
Study Sponsor  ICMJE MemorialCare Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account MemorialCare Health System
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP