Carbon Dioxide Investigation

CO2 Pilot Clinical Investigation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06715410

Enrollment

Registered

2024-12-04

Start date

2024-01-16

Completion date

2024-09-16

Last updated

2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation, Tracheostomy, Laryngeal Mask

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.

Interventions

DEVICECO2

To collect CO2 data

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Other

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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026