Hyperventilation SyndromeTCvsPETCO2NCT03614806
Comparison of Transcutaneous Vs End-tidal CO2 Pressure Measurements in Hyperventilation Syndrome Diagnosis
A study testing Simultaneous Transcutaneous and End-tidal CO2 measurements in people with Hyperventilation Syndrome and Hypocapnia, run by University Hospital, Rouen at 1 site in France.
Trial summary
Hyper Ventilation Syndrome is a frequent disease affecting adults whose diagnosis is often belated or even unrecognized due to the lack of "gold standard" criteria. Its diagnosis currently relies on the Nijmegen score associated with a PetCO2 assesment using a hyperventilation provocation test. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hyperventilation Syndrome, Hypocapnia, Alkalosis, Respiratory
- What is being tested?
- Simultaneous Transcutaneous and End-tidal CO2 measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 21 Dec 2017to 15 Feb 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patient must have reached the age of the civil majority (≥ 18 yo)
- All patients refered to the Physiology department of Rouen University Hospital, France, for an hyperventilation test
- The patient must be a member or beneficiary of a health insurance program
- The patient must have given his / her free and informed consent and signed the consent
Who cannot join
- Sepsis
- Hypercapnia (PaCO2 > 50mmHg)
- Patient treated by long-term oxygen therapy
- Subjects under judicial protection, or adults under any kind of guardianship or under judicial control
- Pregnancy or breastfeeding women
- Electrolytic unbalance
Show all 9Show fewer
- Hyperthyroidism
- Neurological disease
- Probability of drug-induced hyperventilation (progestagens , aspirin, beta agonists)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcutaneous Carbon Dioxide Pressure (tcPCO2) Monitoring Vs End-tidal Partial Pressure Carbon Dioxide (PetCO2) Measurement in the Diagnosis of Hyperventilation Syndrome (HVS) (TCvsPETCO2 )
Hyper Ventilation Syndrome is a frequent disease affecting adults whose diagnosis is often belated or even unrecognized due to the lack of "gold standard" criteria. Its diagnosis currently relies on the Nijmegen score associated with a PetCO2 assesment using a hyperventilation provocation test. Correlation between Nijmegen Questionnaire scores and PetCO2 appears highly variable. PtcCO2 monitoring is a noninvasive alternative method providing a continuous estimation of arterial CO2 pressure (PaCO2) which could represent an advantageous alternative to PetCO2 measurements. Several reports have demonstrated that PtcCO2 monitoring reflects more faithfully PaCO2 than PetCO2, no study have evaluated its value in this indication.
The primary aim of the study is to compare the diagnostic value of PtcPCO2 monitoring with PetCO2, the method currently used.
Read more
Included patient will be invited to fill in the Nijmegen questionnaire and an ambient air gas measurement will be performed. PtcCO2 (mmHg) will be simultaneously measured during hyperventilation test. Nijmegen score signs reproduced by the test will be analysed. HVS diagnosis will be assessed by usual criteria (PetCO2 <30 mmHg at the end of hyperventilation test or under the PetCO2 value at rest, Nijmegen score> 23).
PtcCO2 data will be blinded interpreted later. We will compare if PetCO2 and PtcCO2 leads to the same diagnosis or not.
Read the detailed description
Primary Goal:
Show that the use of either of the two pCO2 measurements leads to the same diagnostic conclusion in HVS diagnosis with a likelihood greater than 80 %.
Secondary Outcome Measures :
Evaluate the correlation between PtcCO2 and PtcCO2 measurements Evaluate tolerance to the hyperventilation test
Inclusion Criteria :
- The patient must have reached the age of the civil majority (≥ 18 yo)
- All patients refered to the Physiology department of Rouen University Hospital, France, for an hyperventilation test
- The patient must be a member or beneficiary of a health insurance program
- The patient must have given his / her free and informed consent and signed the consent
Exclusion Criteria :
- Sepsis
- Hypercapnia (PaCO2 > 50mmHg)
- Patient treated by long-term oxygen therapy
- Subjects under judicial protection, or adults under any kind of guardianship or under judicial control
- Pregnancy or breastfeeding women
- Electrolytic unbalance
- Hyperthyroidism
- Neurological disease
- Probability of drug-induced hyperventilation (progestagens , aspirin, beta agonists)
- Being tested
- Simultaneous Transcutaneous and End-tidal CO2 measurements
- Medical subject headings
- Hypocapnia, Alkalosis, Respiratory, Hyperventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous Transcutaneous and End-tidal CO2 measurementsDiagnostic test
Included patients will be invited to fill in the Nijmegen questionnaire. During the hyperventilation test, PtcCO2 (mmHg) will be recorded simultaneously with the standard End-tidal Cpartial pressure CO2 measurement
| Study group | Role | What they receive |
|---|---|---|
| Patients tested for hyperventilation | Experimental | Simultaneous Transcutaneous and End-tidal CO2 measurements. Eligible patients will be first invited to fill in the Nijmegen questionnaire. Then, in an hyperventilation test, transcutaneous Carbon Dioxide Pressure will be recorded simultaneously with the standard End-tidal Carbon Dioxide Pressure measurement. Receives: Diagnostic Test: Simultaneous Transcutaneous and End-tidal CO2 measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trans-cutaneous Carbon Dioxide pressure
Trans-cutaneous Carbon Dioxide pressure measurements diagnostic of hyperventilation syndrome will be evaluated by comparing it with that of standard
Measured: during hyperventilation test
End-tidal Carbon Dioxide partial pressure
End-tidal Carbon Dioxide partial pressure measurement. Consistency of the diagnostic conclusions reached by either test will be analyzed.
Measured: during hyperventilation test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start21 Dec 2017
- Primary completion15 Feb 2018
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperventilation SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- open label study prospective
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ARTAUD-MACARI Elise, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614806
- Sponsor's protocol ID
- 2017/128/HP
- Acronym
- TCvsPETCO2
- Status last verified
- Jun 2020
- First submitted
- 29 Nov 2017
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Carbon Dioxide Pressure (tcPCO2) Monitoring Vs End-tidal Partial Pressure Carbon Dioxide (PetCO2) Measurement in the Diagnosis of Hyperventilation Syndrome (HVS) (TCvsPETCO2 )
- ClinicalTrials.gov ID
- NCT03614806
- Acronym / sponsor ID
- TCvsPETCO2 / 2017/128/HP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 3 Aug 2018 (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.
Hyper Ventilation Syndrome is a frequent disease affecting adults whose diagnosis is often belated or even unrecognized due to the lack of "gold standard" criteria. Its diagnosis currently relies on the Nijmegen score associated with a PetCO2 assesment using a hyperventilation provocation test. Correlation between Nijmegen Questionnaire scores and PetCO2 appears highly variable. PtcCO2 monitoring is a noninvasive alternative method providing a continuous estimation of arterial CO2 pressure (PaCO2) which could represent an advantageous alternative to PetCO2 measurements. Several reports have demonstrated that PtcCO2 monitoring reflects more faithfully PaCO2 than PetCO2, no study have evaluated its value in this indication.
The primary aim of the study is to compare the diagnostic value of PtcPCO2 monitoring with PetCO2, the method currently used.
Included patient will be invited to fill in the Nijmegen questionnaire and an ambient air gas measurement will be performed. PtcCO2 (mmHg) will be simultaneously measured during hyperventilation test. Nijmegen score signs reproduced by the test will be analysed. HVS diagnosis will be assessed by usual criteria (PetCO2 <30 mmHg at the end of hyperventilation test or under the PetCO2 value at rest, Nijmegen score> 23).
PtcCO2 data will be blinded interpreted later. We will compare if PetCO2 and PtcCO2 leads to the same diagnosis or not.
Detailed description
Primary Goal:
Show that the use of either of the two pCO2 measurements leads to the same diagnostic conclusion in HVS diagnosis with a likelihood greater than 80 %.
Secondary Outcome Measures :
Evaluate the correlation between PtcCO2 and PtcCO2 measurements Evaluate tolerance to the hyperventilation test
Inclusion Criteria :
- The patient must have reached the age of the civil majority (≥ 18 yo)
- All patients refered to the Physiology department of Rouen University Hospital, France, for an hyperventilation test
- The patient must be a member or beneficiary of a health insurance program
- The patient must have given his / her free and informed consent and signed the consent
Exclusion Criteria :
- Sepsis
- Hypercapnia (PaCO2 > 50mmHg)
- Patient treated by long-term oxygen therapy
- Subjects under judicial protection, or adults under any kind of guardianship or under judicial control
- Pregnancy or breastfeeding women
- Electrolytic unbalance
- Hyperthyroidism
- Neurological disease
- Probability of drug-induced hyperventilation (progestagens , aspirin, beta agonists)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open label study prospective
| Arm | Type | Receives |
|---|---|---|
| Patients tested for hyperventilation | Experimental | Diagnostic Test: Simultaneous Transcutaneous and End-tidal CO2 measurementsSimultaneous Transcutaneous and End-tidal CO2 measurements. Eligible patients will be first invited to fill in the Nijmegen questionnaire. Then, in an hyperventilation test, transcutaneous Carbon Dioxide Pressure will be recorded simultaneously with the standard End-tidal Carbon Dioxide Pressure measurement. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- The patient must have reached the age of the civil majority (≥ 18 yo)
- All patients refered to the Physiology department of Rouen University Hospital, France, for an hyperventilation test
- The patient must be a member or beneficiary of a health insurance program
- The patient must have given his / her free and informed consent and signed the consent
Key exclusion criteria (9 listed)
- Sepsis
- Hypercapnia (PaCO2 > 50mmHg)
- Patient treated by long-term oxygen therapy
- Subjects under judicial protection, or adults under any kind of guardianship or under judicial control
- Pregnancy or breastfeeding women
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 |
|---|---|---|
| Simultaneous Transcutaneous and End-tidal CO2 measurementsIncluded patients will be invited to fill in the Nijmegen questionnaire. During the hyperventilation test, PtcCO2 (mmHg) will be recorded simultaneously with the standard End-tidal Cpartial pressure CO2 measurement | Diagnostic test | Patients tested for hyperventilation |
Primary outcome
Trans-cutaneous Carbon Dioxide pressure
Time frame: during hyperventilation test
Trans-cutaneous Carbon Dioxide pressure measurements diagnostic of hyperventilation syndrome will be evaluated by comparing it with that of standard
End-tidal Carbon Dioxide partial pressure
Time frame: during hyperventilation test
End-tidal Carbon Dioxide partial pressure measurement. Consistency of the diagnostic conclusions reached by either test will be analyzed.
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 29 Jun 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Hyperventilation Syndrome
Not yet recruitingObservational study
Symptomatic Hyperventilation in Individuals Living With Stroke
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RecruitingObservational study
Dysfunctional Breathing in Post COVID-19 Condition.
Post COVID-19 Condition (PCC), Dysfunctional Breathing
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.
ARTAUD-MACARI Elise, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simultaneous Transcutaneous and End-tidal CO2 measurements in people with Hyperventilation Syndrome and Hypocapnia, run by University Hospital, Rouen at 1 site in France.
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 4 inclusion and 9 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 29 Jun 2020. 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 France. 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?
Trans-cutaneous Carbon Dioxide pressure (time frame: during hyperventilation test). The study lists 2 primary outcomes in all. 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 29 Jun 2020.