Predictive Properties of the Hyperventilation Provocation Test for the Diagnosis of the Hyperventilation Syndrome

Completed

• Conditions: Hyperventilation Syndrome

• Registration Number: NCT05100290
• Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre

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.

Study Timeline

• Study Start: 2018-06-15
• Primary Completion: 2021-10-15
• Study First Submitted: 2021-10-18
• Study First Submitted QC: 2021-10-18
• Study First Posted: 2021-10-29
• Study Completion: 2021-12-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-14
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PetCO2 recovery (5min)	5 minute of recovery	PetCO2 at the end (5th minute) of the recovery phase of the HPTest

Secondary Outcome Measures

Name	Time	Method
PetCO2 recovery (3min)	3 minute of recovery	PetCO2 at the end (3d minute) of the recovery phase of the HPTest

Trial Locations

Locations (1)

CHU St Pierre; 🇧🇪 Brussels, Brabant, Belgium