Carbon Dioxide Investigation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-16

Study Completion Date

2024-09-16

Brief Summary

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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

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Conditions

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Intubation Tracheostomy Laryngeal Mask

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CO2 data collection

To collect data from CO2

Group Type OTHER

CO2

Intervention Type DEVICE

To collect CO2 data

Interventions

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CO2

To collect CO2 data

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tero Varpula, MD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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Helsinki University Hospital

Espoo, Uusimaa, Finland

Site Status

Countries

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Finland

Other Identifiers

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21290936998

Identifier Type: -

Identifier Source: org_study_id