Clinical trial NCT05100290: Predictive Properties of the Hyperventilation Provocation Test for the Diagnosis of the Hyperventilation Syndrome
Official title: Predictive Properties of the Hyperventilation Provocation Test for the Diagnosis of the Hyperventilation Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperventilation Syndrome
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
Collaborators: name: Université Libre de Bruxelles
name: Hopitaux Iris Sud
First posted: 2021-10-29
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who visited the pulmonary department and performed a HPTest on medical prescription

Brief summary: The Hyperventilation Provocation Test (HPTest) associated with end-tidal CO2 pressure (PETCO2) measurement is a diagnostic tool for idiopathic hyperventilation syndrome (HVS). However, interpretation of HPTest remains unclear regarding the relevant PETCO2 values to consider and the occurrence of subjective symptoms.

This case-control study aims to identify accurate HPTest measurements for the diagnosis of HVS, regardless of symptoms occurrence.

Detailed description: In a first stage, the investigators will analyze in a prospective way a training cohort of HPTest datas from 74 subjects, involving 37 subjects with complaints and a Nijmegen questionnaire score of ≥23/64 (HVS+) matched on gender, age, height, weight and BMI category with 37 healthy controls without complaints and a Nijmegen questionnaire score of \<23/64 (HVS-)(16).

All data will have to be collected by the same equipment and by the same operators in the pulmonology department of the CHU-St Pierre-Brussels between June 2018 and October 2021.

To rule out confounding respiratory pathology, each participant will have completed spirometry and methacholine testing, that will have a result within expected normal values.

For both cohorts, kinetics of the PETCO2 recorded during each of the 3 phases of the HPTest (adaptation, hyperventilation and recovery) will be mathematically modeled by an curvilinear model with the parameters (A, A', a and a') noted from the kinetic equation (TAU) : TAU \[PETCO2(t)〖=A+a(1-exp〗\^((b-t)/c))\]. For any observed differences in parameters between groups, the Area Under Curves will be estimated at the cut-off that offers the best Sensitivity and Specificity. False negative and false positive rates will be estimated.

The probability of a type I error is set at 5%.

In a second stage, in order to confirm/infirm the results, a retrospective validation cohort from another care setting, including subjects without confounding pathology, who completed a Nijmegen questionnaire and a HVTest between 2018 and 2021, will be analysed in the same way than the training cohort.

Eligibility criteria: Inclusion Criteria:

* Anyone over 18 years of age who has completed an HPTest and a Nijmegen questionnaire between 2015 and 2020

Exclusion Criteria:

-

Primary outcomes:
measure: PetCO2 recovery (5min)
timeFrame: 5 minute of recovery
Secondary outcomes:
measure: PetCO2 recovery (3min)
timeFrame: 3 minute of recovery
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU St Pierre
state: Brabant
Study officials:
affiliation: CHU St PIerre
name: Vincent Ninane
role: STUDY_DIRECTOR
References: