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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05100290
Enrollment
74
Registered
2021-10-29
Start date
2018-06-15
Completion date
2021-12-31
Last updated
2022-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperventilation Syndrome

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.

Interventions

DIAGNOSTIC_TESTHyperventilation Provocation Test (HPTest)

During the HPTest, the subject is comfortably seated in a chair with armrests and breathes in a mouthpiece with a salivary collector and a nasal clamp. Parameters of ventilation and gas exchange are analyzed via an Oxycon ProTM (SN808008) with TripleV-Volume Sensor digital(Jaeger). The HPTest begins with a 3-minutes adaptation phase during which the patient is asked to breathe normally. During the 3-minutes of voluntary hyperventilation phase, the patient is asked to increase his tidal volume and support a breath rate of at least 30/min in order to reduce his PETCO2 by at least 50%. During the recovery phase of the HPTest, the patient is invited to regain a natural breathing for 5 minutes, without guidance on tidal volume or breath rate.

Sponsors

Université Libre de Bruxelles
CollaboratorOTHER
Hopitaux Iris Sud
CollaboratorUNKNOWN
Centre Hospitalier Universitaire Saint Pierre
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
PetCO2 recovery (5min)5 minute of recoveryPetCO2 at the end (5th minute) of the recovery phase of the HPTest

Secondary

MeasureTime frameDescription
PetCO2 recovery (3min)3 minute of recoveryPetCO2 at the end (3d minute) of the recovery phase of the HPTest

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026