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

NCT03614806 | Completed DMC

• 1 other identifier: 2017/128/HP
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperventilation Syndrome; Hypocapnia; Alkalosis, Respiratory; Hyperventilation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Diagnostic Test: Simultaneous Transcutaneous and End-tidal CO2 measurements

Interventions

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

Patients tested for hyperventilation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Physiology department of Rouen University Hospital,

Rouen, 76000, France

Location

MeSH Terms

Conditions

Hypocapnia; Alkalosis, Respiratory; Hyperventilation

Condition Hierarchy (Ancestors)

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

Study Officials

• ARTAUD-MACARI Elise, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open label study prospective

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: August 3, 2018
• Study Start: December 21, 2017
• Primary Completion: February 15, 2018
• Study Completion: February 15, 2018
• Last Updated: June 29, 2020

Record last verified: 2020-06

Locations

FR (1)