Carbon Dioxide Investigation

CO2 Pilot Clinical Investigation

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 Overview

• Status: Completed
• Conditions: Tracheostomy; Intubation; Laryngeal Mask
• Intervention / Treatment: Device: CO2

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Uusimaa
    • Espoo, Uusimaa, Finland, 02740
      • Helsinki University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: CO2 data collection; To collect data from CO2	Device: CO2; To collect CO2 data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Principal Investigator: Tero Varpula, MD, Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2024
• Primary Completion (Actual): September 16, 2024
• Study Completion (Actual): September 16, 2024

Study Registration Dates

• First Submitted: June 5, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Estimated): December 4, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 21290936998

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No