Comparison of Transcutaneous Vs End-tidal CO2 Pressure Measurements in Hyperventilation Syndrome Diagnosis

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.

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Key information

Conditions

Hyperventilation Syndrome Acid-Base Imbalance Alkalosis Alkalosis, Respiratory Hyperventilation Hypocapnia Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physiology department of Rouen University Hospital,

Rouen, 76000, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Simultaneous Transcutaneous and End-tidal CO2 measurements

Diagnostic 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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Transcutaneous Carbon Dioxide Pressure (tcPCO2) Monitoring Vs End-tidal Partial Pressure Carbon Dioxide (PetCO2) Measurement in the Diagnosis of Hyperventilation Syndrome (HVS) (TCvsPETCO2 )

Acronym: TCvsPETCO2

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Aug 3, 2018
Registry last updated: Jun 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed