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

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.

Study Overview

• Status: Completed
• Conditions: Hyperventilation Syndrome
• Intervention / Treatment: Diagnostic test: Hyperventilation Provocation Test (HPTest)

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 Type: Observational
• Enrollment (Actual): 74

Contacts and Locations

Study Locations

• Belgium
  • Brabant
    • Brussels, Brabant, Belgium, 1000
      • Chu St Pierre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who visited the pulmonary department and performed a HPTest on medical prescription

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	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.
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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PetCO2 recovery (5min)	PetCO2 at the end (5th minute) of the recovery phase of the HPTest	5 minute of recovery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PetCO2 recovery (3min)	PetCO2 at the end (3d minute) of the recovery phase of the HPTest	3 minute of recovery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Saint Pierre
• Collaborators: Université Libre de Bruxelles; Hopitaux Iris Sud
• Investigators: Study Director: Vincent Ninane, Chu St Pierre

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2018
• Primary Completion (Actual): October 15, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease; Signs and Symptoms, Respiratory; Syndrome; Hyperventilation
• Other Study ID Numbers: B076201836758-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No