NCT03268395

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
266

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

August 29, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

August 31, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

August 29, 2017

Last Update Submit

August 30, 2017

Conditions

Respiratory Complication

Outcome Measures

Primary Outcomes (1)

  • Observed mean CO2 difference

    The observed difference between arterial blood gas and transcutaneous CO2 monitor readings

    1 Minute

Study Arms (1)

CO2 Measurement

OTHER

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

Interventions

Arterial Blood Gas and Transcutaneous CO2 MonitorDIAGNOSTIC_TEST

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

CO2 Measurement

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Neonates in NICU with an arterial line

You may not qualify if:

  • Birth Weight \< 1000g

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial University Medical Center

Savannah, Georgia, 31404, United States

RECRUITING

Related Publications (1)

  • Bernet-Buettiker V, Ugarte MJ, Frey B, Hug MI, Baenziger O, Weiss M. Evaluation of a new combined transcutaneous measurement of PCO2/pulse oximetry oxygen saturation ear sensor in newborn patients. Pediatrics. 2005 Jan;115(1):e64-8. doi: 10.1542/peds.2004-0946. Epub 2004 Dec 15.

    PMID: 15601814RESULT

MeSH Terms

Interventions

Blood Gas Analysis

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemInvestigative Techniques

Central Study Contacts

Charli E Cohen, BS

CONTACT

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

Daniel Candler, MD

CONTACT

9123508202sandlda1@memorialhealth.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2017

First Posted

August 31, 2017

Study Start

August 29, 2017

Primary Completion

August 29, 2018

Study Completion

December 30, 2018

Last Updated

August 31, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)