Comparison of Transcutaneous Vs End-tidal CO2 Pressure Measurements in Hyperventilation Syndrome Diagnosis (TCvsPETCO2)

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.

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.

Study Overview

• Status: Completed
• Conditions: Hyperventilation; Hypocapnia; Hyperventilation Syndrome; Alkalosis, Respiratory
• Intervention / Treatment: Diagnostic test: Simultaneous Transcutaneous and End-tidal CO2 measurements

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 :

1. The patient must have reached the age of the civil majority (≥ 18 yo)
2. All patients refered to the Physiology department of Rouen University Hospital, France, for an hyperventilation test
3. The patient must be a member or beneficiary of a health insurance program
4. The patient must have given his / her free and informed consent and signed the consent

Exclusion Criteria :

1. Sepsis
2. Hypercapnia (PaCO2 > 50mmHg)
3. Patient treated by long-term oxygen therapy
4. Subjects under judicial protection, or adults under any kind of guardianship or under judicial control
5. Pregnancy or breastfeeding women
6. Electrolytic unbalance
7. Hyperthyroidism
8. Neurological disease
9. Probability of drug-induced hyperventilation (progestagens , aspirin, beta agonists)

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76000
    • Physiology department of Rouen University Hospital,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The patient must have reached the age of the civil majority (≥ 18 yo)
2. All patients refered to the Physiology department of Rouen University Hospital, France, for an hyperventilation test
3. The patient must be a member or beneficiary of a health insurance program
4. The patient must have given his / her free and informed consent and signed the consent

Exclusion Criteria:

1. Sepsis
2. Hypercapnia (PaCO2 > 50mmHg)
3. Patient treated by long-term oxygen therapy
4. Subjects under judicial protection, or adults under any kind of guardianship or under judicial control
5. Pregnancy or breastfeeding women
6. Electrolytic unbalance
7. Hyperthyroidism
8. Neurological disease
9. Probability of drug-induced hyperventilation (progestagens , aspirin, beta agonists)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients tested for hyperventilation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	during hyperventilation test

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: ARTAUD-MACARI Elise, MD, ROUEN university hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2017
• Primary Completion (Actual): February 15, 2018
• Study Completion (Actual): February 15, 2018

Study Registration Dates

• First Submitted: November 29, 2017
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): June 29, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Respiratory Tract Diseases; Respiration Disorders; Disease; Signs and Symptoms, Respiratory; Acid-Base Imbalance; Syndrome; Alkalosis; Hyperventilation; Alkalosis, Respiratory; Hypocapnia
• Other Study ID Numbers: 2017/128/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No