An interventional study of Simultaneous Transcutaneous and End-tidal CO2 measurements in Hyperventilation Syndrome, Hypocapnia and Alkalosis, Respiratory, sponsored by University Hospital, Rouen. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2020-06-29.
Sponsored by University Hospital, Rouen · Not applicable, Interventional, and Diagnostic
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.
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 :
Exclusion Criteria :
43 studies on the registry are indexed under Hyperventilation; 6 are open to participants now.
This study's enrollment of 14 is below the median of 40 across 31 interventional studies indexed under Hyperventilation.
Browse Hyperventilation studies →University Hospital, Rouen is the lead sponsor of 418 studies on the registry; 106 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Simultaneous Transcutaneous and End-tidal CO2 measurements
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
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
Time frame: 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.
Time frame: during hyperventilation test
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Dec 2017 to primary completion in Feb 2018, 1 month.
Of 16 interventional studies with no phase under Hyperventilation, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 37. This study's 1 month is below that.
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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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