Carbon Dioxide Investigation

General Electric (GE)

Status: Completed

Conditions: Laryngeal Mask; Tracheostomy; Intubation

Treatments: Device: CO2

Study type: Interventional

Funder types: Industry

Identifiers

NCT06715410

21290936998

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 2+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

CO2 data collection

Other group

Description:

To collect data from CO2

Treatment:

Device: CO2