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

Hyperventilation Clinical Trial

— TCvsPETCO2  

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 )

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03614806
• Other study ID #: 2017/128/HP
• Status: Completed
• Phase: N/A
• Start date: December 21, 2017
• Est. completion date: February 15, 2018

Study information

• Verified date: June 2020
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 15, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Alkalosis
• Alkalosis, Respiratory
• Hyperventilation
• Hyperventilation Syndrome
• Hypocapnia
• Syndrome

Intervention

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

Locations

Country	Name	City	State
France	Physiology department of Rouen University Hospital,	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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