Carbon Dioxide Investigation

GE Healthcare42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Intubation Tracheostomy Laryngeal Mask

Interventions

CO2DEVICE

To collect CO2 data

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

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

Locations (1)

Helsinki University Hospital

Espoo, Uusimaa, Finland

Outcomes

Primary Outcomes

Collection of data

Raw parameter data will be collected from subjects in clinical settings.

Time frame: From admission to discharge, maximum of 48 hours

Secondary Outcomes

Evaluation of the performance and usability of CO2 measurement

Research nurses will fill in questionnaires during the study

Time frame: From admission to discharge, maximum of 48 hours

Data from ClinicalTrials.gov

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