Carbon Dioxide Investigation | NCT06715410

Studies
Carbon Dioxide Investigation

NCT06715410

Sponsor

GE Healthcare

Status

Completed

Last Update Posted

Dec 4, 2024Actual

Enrollment

42Actual

Phase

Not Applicable

Conditions

Intubation
Tracheostomy
Laryngeal Mask

Interventions

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 16, 2024Actual

Primary Completion Date

Sep 16, 2024Actual

Completion Date

Sep 16, 2024Actual

First Submitted Date

Jun 5, 2024

First Submission Date that Met QC Criteria

Dec 3, 2024

First Posted Date

Dec 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2024

Last Update Posted Date

Dec 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigational device enables monitoring of EtCO2, FiCO2 and respiration rate values.

The purpose of this clinical study is to collect parameter raw data for development, evaluate the operational and functional features of the investigational device as well as ease of use of the system.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CO2 data collection	Other	To collect data from CO2	Device: CO2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CO2	Device	To collect CO2 data	CO2 data collection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Collection of data	Raw parameter data will be collected from subjects in clinical settings.	From admission to discharge, maximum of 48 hours

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of the performance and usability of CO2 measurement	Research nurses will fill in questionnaires during the study	From admission to discharge, maximum of 48 hours

Other Outcomes

Measure	Description	Time Frame
To collect safety information	Collection of type and number of AEs, SAEs, and device issues.	From admission to discharge, maximum of 48 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults and pediatric patients that are endotracheally intubated, tracheostomized or have a laryngeal mask or similar
Tolerate airway adapter dead space of 6.7 ml
Are above 10 kg
2 years of age of older
Able to provide written informed consent or have a LDR to provide written informed consent
Are being cared for in hospital unit and are expected to remain in the unit for the duration of the study procedure

Exclusion Criteria:

Are known to be pregnant
Are breastfeeding
Are suffering from infection(s) or immunocompromised patients that require isolation.
PI or designee decision due to subject health condition

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tero Varpula, MD	Helsinki University Central Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Hospital		Espoo	Uusimaa	02740	Finland