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

NCT ID: NCT05100290

Last Updated: 2022-04-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-15
• Study Completion Date: 2021-12-31

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.

Conditions

Hyperventilation Syndrome

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

HVS+

Subjects without documented respiratory or cardiac disease, with a spirometry and metacholine tests within expected values AND with complaints documented by a Nijmegen questionnaire score of ≥23/64 (suspected of idiopathic hyperventilation)

Hyperventilation Provocation Test (HPTest)

Intervention Type: DIAGNOSTIC_TEST

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.

HVS-

Healthy controls without documented respiratory or cardiac disease, with a spirometry and metacholine tests within expected values AND without complaints documented by a Nijmegen questionnaire score of \<23/64

Hyperventilation Provocation Test (HPTest)

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université Libre de Bruxelles

OTHER

Sponsor Role: collaborator

Hopitaux Iris Sud

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Universitaire Saint Pierre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Ninane

Role: STUDY_DIRECTOR

CHU St PIerre

Locations

CHU St Pierre

Brussels, Brabant, Belgium

Countries

Belgium

Other Identifiers

B076201836758-1

Identifier Type: -

Identifier Source: org_study_id