IntubationNCT06715410
Carbon Dioxide Investigation
A study testing CO2 in people with Intubation and Tracheostomy, run by GE Healthcare at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Intubation, Tracheostomy, Laryngeal Mask
- What is being tested?
- CO2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFinland
- Study dates
- 16 Jan 2024to 16 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Intubation, Tracheostomy, Laryngeal Mask
- Being tested
- CO2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2Device
To collect CO2 data
| Study group | Role | What they receive |
|---|---|---|
| CO2 data collection | Other | To collect data from CO2 Receives: Device: CO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of data
Raw parameter data will be collected from subjects in clinical settings.
Measured: From admission to discharge, maximum of 48 hours
Secondary outcomes (1)
Evaluation of the performance and usability of CO2 measurement
Research nurses will fill in questionnaires during the study
Measured: From admission to discharge, maximum of 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start16 Jan 2024
- Primary completion16 Sep 2024
- Study completion16 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tero Varpula, MD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715410
- Sponsor's protocol ID
- 21290936998
- Status last verified
- Dec 2024
- First submitted
- 5 Jun 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CO2 Pilot Clinical Investigation
- ClinicalTrials.gov ID
- NCT06715410
- Acronym / sponsor ID
- 21290936998
- Conditions
- Intubation, Tracheostomy, Laryngeal Mask
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 16 Sep 2024 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CO2 data collection | Other | Device: CO2To collect data from CO2 |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2To collect CO2 data | Device | CO2 data collection |
Primary outcome
Collection of data
Time frame: From admission to discharge, maximum of 48 hours
Raw parameter data will be collected from subjects in clinical settings.
1 secondary outcome
Evaluation of the performance and usability of CO2 measurement
Time frame: From admission to discharge, maximum of 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tero Varpula, MD principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 in people with Intubation and Tracheostomy, run by GE Healthcare at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of data (time frame: From admission to discharge, maximum of 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.