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Trial record 90 of 667 for:    CARBON DIOXIDE AND arterial

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

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ClinicalTrials.gov Identifier: NCT03614806
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

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.


Condition or disease Intervention/treatment Phase
Hyperventilation Syndrome Hypocapnia Alkalosis, Respiratory Hyperventilation Diagnostic Test: Simultaneous Transcutaneous and End-tidal CO2 measurements Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Intervention Model: Single Group Assignment
Intervention Model Description: open label study prospective
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 )
Actual Study Start Date : December 21, 2017
Estimated Primary Completion Date : December 21, 2020
Estimated Study Completion Date : December 21, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614806


Contacts
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Contact: ARTAUD-MACARI Elise, MD 00222 32 88 90 83 Elise.Artaud-Macari@chu-rouen.fr
Contact: GODEAU Elise, MD 00222 32 88 90 83 elisegodeau@gmail.com

Locations
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France
Physiology department of Rouen University Hospital, Recruiting
Rouen, France, 76000
Contact: ARTAUD-MACARI Elise, MD       Elise.Artaud-Macari@chu-rouen.fr   
Contact: GODEAU Elise, MD       elisegodeau@gmail.com   
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: ARTAUD-MACARI Elise, MD Rouen University Hospital

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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT03614806     History of Changes
Other Study ID Numbers: 2017/128/HP
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Hyperventilation
Alkalosis, Respiratory
Alkalosis
Syndrome
Hypocapnia
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Acid-Base Imbalance
Metabolic Diseases