NCT05100290

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 74 (actual)
• Sponsor: Centre Hospitalier Universitaire Saint Pierre · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hyperventilation Syndrome

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Hyperventilation 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.

Timeline

• Start date: 2018-06-15
• Primary completion: 2021-10-15
• Completion: 2021-12-31
• First posted: 2021-10-29
• Last updated: 2022-04-21

Locations

1 site across 1 country: Belgium