Carbon Dioxide Investigation

NCT06715410 | Completed

• 1 other identifier: 21290936998
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation; Tracheostomy; Laryngeal Mask

Outcome Measures

Primary Outcomes (1)

• Collection of data

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

  From admission to discharge, maximum of 48 hours

Secondary Outcomes (1)

• Evaluation of the performance and usability of CO2 measurement

  From admission to discharge, maximum of 48 hours

Other Outcomes (1)

• To collect safety information

  From admission to discharge, maximum of 48 hours

Study Arms (1)

CO2 data collection

OTHER

To collect data from CO2

Device: CO2

Interventions

CO2 DEVICE

To collect CO2 data

CO2 data collection

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

Helsinki University Hospital

Espoo, Uusimaa, 02740, Finland

Location

Study Officials

• Tero Varpula, MD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: December 4, 2024
• Study Start: January 16, 2024
• Primary Completion: September 16, 2024
• Study Completion: September 16, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

FI (1)