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

Primary Purpose

Hyperventilation Syndrome, Hypocapnia, Alkalosis, Respiratory

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Simultaneous Transcutaneous and End-tidal CO2 measurements
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hyperventilation Syndrome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Physiology department of Rouen University Hospital,

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients tested for hyperventilation

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
November 29, 2017
Last Updated
June 26, 2020
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT03614806
Brief Title
Comparison of Transcutaneous Vs End-tidal CO2 Pressure Measurements in Hyperventilation Syndrome Diagnosis
Acronym
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 )
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
December 21, 2017 (Actual)
Primary Completion Date
February 15, 2018 (Actual)
Study Completion Date
February 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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 : 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperventilation Syndrome, Hypocapnia, Alkalosis, Respiratory, Hyperventilation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
open label study prospective
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients tested for hyperventilation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Simultaneous Transcutaneous and End-tidal CO2 measurements
Intervention Description
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 Outcome Measure Information:
Title
Trans-cutaneous Carbon Dioxide pressure
Description
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
Title
End-tidal Carbon Dioxide partial pressure
Description
End-tidal Carbon Dioxide partial pressure measurement. Consistency of the diagnostic conclusions reached by either test will be analyzed.
Time Frame
during hyperventilation test

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ARTAUD-MACARI Elise, MD
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physiology department of Rouen University Hospital,
City
Rouen
ZIP/Postal Code
76000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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