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OpenTrials
Completed

NCT Number: NCT06715410

Carbon Dioxide 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.

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Key information

Conditions

Intubation Laryngeal Mask Tracheostomy

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital

Espoo, Uusimaa, 02740, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CO2

Device

To collect CO2 data

Primary outcomes

  1. Collection of data

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

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

Secondary outcomes

  1. Evaluation of the performance and usability of CO2 measurement

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

    Research nurses will fill in questionnaires during the study

Other outcomes

  1. To collect safety information

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

    Collection of type and number of AEs, SAEs, and device issues.

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Official study title

CO2 Pilot Clinical Investigation

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 4, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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