Cystic FibrosisNCT03734822
Comparative Analysis of CO2 Monitoring Methods in Patients With CF Undergoing General Anesthesia
A study testing End tidal CO2 (EtCO2), Transcutaneous CO2 (TCO2) and Capillary CO2 (CapCO2) in people with Cystic Fibrosis, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
Four methods are routinely used to monitor CO2 in patients. End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia. CO2 is also monitored in other healthcare settings transcutaneously (TCO2), via finger stick capillary CO2 (CapCO2), and arterial blood gas (ABG). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- End tidal CO2 (EtCO2), Transcutaneous CO2 (TCO2) and Capillary CO2 (CapCO2)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2016to 20 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have a confirmed diagnosis of cystic fibrosis (positive sweat chloride value ≥ 60 mEq/L) and/or genotype with two identifiable mutations consistent with CF, accompanied by one or more clinical features consistent with the CF phenotype)
- Hemodynamically stable undergoing general anesthesia for a scheduled procedure
Who cannot join
- Patients not diagnosed with CF
- CF patients undergoing anesthesia for emergency procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Four methods are routinely used to monitor CO2 in patients. End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia. CO2 is also monitored in other healthcare settings transcutaneously (TCO2), via finger stick capillary CO2 (CapCO2), and arterial blood gas (ABG). The purpose of this study is to perform all four measurements simultaneously during general anesthesia to identify which measure provides the most accurate data with the least amount of patient risk.
- Conditions
- Cystic Fibrosis
- Being tested
- End tidal CO2 (EtCO2), Transcutaneous CO2 (TCO2), Capillary CO2 (CapCO2), Arterial blood gas (ABG)
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End tidal CO2 (EtCO2)Other
End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia.
Transcutaneous CO2 (TCO2)Device
Also called The SenTec Digital Monitoring System (SDMS)
Continuous and noninvasive real-time monitoring of transcutaneous CO2.
Capillary CO2 (CapCO2)Diagnostic test
Capillary CO2 collected by finger stick and run on the i-STAT handheld blood analyzer.
Arterial blood gas (ABG)Diagnostic test
Arterial blood gas collected from the radial artery and run on the i-STAT handheld blood analyzer.
| Study group | Role | What they receive |
|---|---|---|
| CF | Other | Cystic fibrosis patients undergoing general anesthesia. Receives: Other: End tidal CO2 (EtCO2); Device: Transcutaneous CO2 (TCO2); Diagnostic Test: Capillary CO2 (CapCO2); Diagnostic Test: Arterial blood gas (ABG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of CO2 Levels
Looking at the accuracy of CO2 levels assessed via end tidal CO2 (ETCO2), capillary CO2 (Cap-CO2), and transcutaneous CO2 (TCCO2) compared to arterial blood gas (ABG) which is the gold standard.
Measured: Immediately following induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start10 Mar 2016
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne May, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734822
- Sponsor's protocol ID
- IRB15-00797
- Status last verified
- Mar 2019
- First submitted
- 23 Oct 2018
- Last updated
- 14 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of CO2 Monitoring Methods in Patients With CF Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT03734822
- Acronym / sponsor ID
- IRB15-00797
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 10 Mar 2016 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Posted 14 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Four methods are routinely used to monitor CO2 in patients. End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia. CO2 is also monitored in other healthcare settings transcutaneously (TCO2), via finger stick capillary CO2 (CapCO2), and arterial blood gas (ABG). The purpose of this study is to perform all four measurements simultaneously during general anesthesia to identify which measure provides the most accurate data with the least amount of patient risk.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CF | Other | Other: End tidal CO2 (EtCO2), Device: Transcutaneous CO2 (TCO2), Diagnostic Test: Capillary CO2 (CapCO2), Diagnostic Test: Arterial blood gas (ABG)Cystic fibrosis patients undergoing general anesthesia. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Have a confirmed diagnosis of cystic fibrosis (positive sweat chloride value ≥ 60 mEq/L) and/or genotype with two identifiable mutations consistent with CF, accompanied by one or more clinical features consistent with the CF phenotype)
- Hemodynamically stable undergoing general anesthesia for a scheduled procedure
Key exclusion criteria (2 listed)
- Patients not diagnosed with CF
- CF patients undergoing anesthesia for emergency procedures
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 |
|---|---|---|
| End tidal CO2 (EtCO2)End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia. | Other | CF |
| Transcutaneous CO2 (TCO2)Also: The SenTec Digital Monitoring System (SDMS)Continuous and noninvasive real-time monitoring of transcutaneous CO2. | Device | CF |
| Capillary CO2 (CapCO2)Capillary CO2 collected by finger stick and run on the i-STAT handheld blood analyzer. | Diagnostic test | CF |
| Arterial blood gas (ABG)Arterial blood gas collected from the radial artery and run on the i-STAT handheld blood analyzer. | Diagnostic test | CF |
Primary outcome
Accuracy of CO2 Levels
Time frame: Immediately following induction of anesthesia
Looking at the accuracy of CO2 levels assessed via end tidal CO2 (ETCO2), capillary CO2 (Cap-CO2), and transcutaneous CO2 (TCCO2) compared to arterial blood gas (ABG) which is the gold standard.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing End tidal CO2 (EtCO2), Transcutaneous CO2 (TCO2) and Capillary CO2 (CapCO2) in people with Cystic Fibrosis, run by Nationwide Children's Hospital at 1 site in United States.
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 2 inclusion and 2 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 14 Mar 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 14 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Accuracy of CO2 Levels (time frame: Immediately following induction of anesthesia). 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 14 Mar 2019.