Recruiting

Observational Study

Sponsor:

Memorial Health University Medical Center

Code:

NCT03268395

Conditions

Respiratory Complication

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Arterial Blood Gas and Transcutaneous CO2 Monitor

Study Details

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.

Conditions

Respiratory Complication

Study ID

NCT03268395

Start date

Aug 29, 2017

Status verified date

Aug, 2017

Completion date

Dec 30, 2018

Anticipated

Primary completion date

Aug 29, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Neonates in NICU with an arterial line

Exclusion Criteria:

  • Birth Weight < 1000g

Study Design

Enrollment

266 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: 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.

Interventions

Arterial Blood Gas and Transcutaneous CO2 Monitor

Each patient will receive both an arterial blood gas and a transcutaneous CO2 monitor test.

Primary outcome measure

  • Observed mean CO2 difference [ Time Frame: 1 Minute ]

Central Contacts and Locations

Central contacts

Charli E Cohen, BS

6782628299Charli.Elyse.Cohen@live.mercer.edu

Daniel Candler, MD

9123508202sandlda1@memorialhealth.com

Locations

Memorial University Medical Center

Recruiting

Savannah, Georgia, United States, 31404

Contacts

Charli E Cohen, BS

912-350-8202Charli.Elyse.Cohen@live.mercer.edu

Daniel Sandler, MD

9123508202

More Information

Sponsor

Memorial Health University Medical Center

Last update posted

Aug 31, 2017

Last verified

Aug, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Health University Medical Center on 2017-08-31.