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

NCT05100290 | Completed

• 1 other identifier: B076201836758-1
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperventilation Syndrome

Outcome Measures

Primary Outcomes (1)

• PetCO2 recovery (5min)

  PetCO2 at the end (5th minute) of the recovery phase of the HPTest

  5 minute of recovery

Secondary Outcomes (1)

• PetCO2 recovery (3min)

  3 minute of recovery

Study Arms (2)

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)

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)

Interventions

Hyperventilation Provocation Test (HPTest) 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+; HVS-

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead
• Université Libre de Bruxelles: collaborator
• Hopitaux Iris Sud: collaborator

Study Sites (1)

CHU St Pierre

Brussels, Brabant, 1000, Belgium

Location

Study Officials

• Vincent Ninane

  CHU St PIerre

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: October 29, 2021
• Study Start: June 15, 2018
• Primary Completion: October 15, 2021
• Study Completion: December 31, 2021
• Last Updated: April 21, 2022

Record last verified: 2022-04

Locations

BE (1)