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Correlation of CO2 Measured by Blood Gas vs Transcutaneous Monitor

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ClinicalTrials.gov Identifier: NCT03268395
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
Memorial Health University Medical Center

Brief Summary:
The purpose of this clinical investigation is to compare transcutaneous CO2 (TCCO2) levels measured non-invasively using the SenTec Transcutaneous CO2 Monitor to PaCO2 levels measured on arterial blood gas (ABG) samples in neonatal patients being treated for respiratory distress in the Neonatal Intensive Care Unit (NICU) at Memorial University Medical Center.

Condition or disease Intervention/treatment Phase
Respiratory Complication Diagnostic Test: Arterial Blood Gas and Transcutaneous CO2 Monitor Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 266 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Correlation of CO2 Measured by SenTec Transcutaneous Monitoring With Arterial Blood Gas CO2 Levels in Neonates
Actual Study Start Date : August 29, 2017
Estimated Primary Completion Date : August 29, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
CO2 Measurement
Each subject will received simultaneous arterial blood gas CO2 and transcutaneous CO2 monitor assessments. The correlation of these two measurements will be compared.
Diagnostic Test: Arterial Blood Gas and Transcutaneous CO2 Monitor
Each patient will receive both an arterial blood gas and a transcutaneous CO2 monitor test.




Primary Outcome Measures :
  1. Observed mean CO2 difference [ Time Frame: 1 Minute ]
    The observed difference between arterial blood gas and transcutaneous CO2 monitor readings



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

Inclusion Criteria:

  • Neonates in NICU with an arterial line

Exclusion Criteria:

  • Birth Weight < 1000g

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): NCT03268395


Contacts
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Contact: Charli E Cohen, BS 6782628299 Charli.Elyse.Cohen@live.mercer.edu
Contact: Daniel Candler, MD 9123508202 sandlda1@memorialhealth.com

Locations
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United States, Georgia
Memorial University Medical Center Recruiting
Savannah, Georgia, United States, 31404
Contact: Charli E Cohen, BS    912-350-8202    Charli.Elyse.Cohen@live.mercer.edu   
Contact: Daniel Sandler, MD    9123508202      
Sponsors and Collaborators
Memorial Health University Medical Center

Publications of Results:
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Responsible Party: Memorial Health University Medical Center
ClinicalTrials.gov Identifier: NCT03268395     History of Changes
Other Study ID Numbers: 2017.07.02
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No