Carbon Dioxide Investigation

Not Applicable

Completed

• Conditions: Intubation; Tracheostomy; Laryngeal Mask

• Registration Number: NCT06715410
• Lead Sponsor: GE Healthcare

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 available

Study Timeline

• Study Start: 2024-01-16
• Study First Submitted: 2024-06-05
• Primary Completion: 2024-09-16
• Study Completion: 2024-09-16
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-04
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Helsinki University Hospital; 🇫🇮 Espoo, Uusimaa, Finland