Normalizing CO2 in Chronic Hyperventilation by a Novel Breathing Mask: A Pilot Study

Not Applicable

Completed

• Conditions: Dysfunctional Breathing; Respiratory Alkalosis; Hyperventilation; Chronic Idiopathic Hyperventilation
• Interventions: Device: Partial Rebreathing Mask

• Registration Number: NCT01575665
• Lead Sponsor: University of Aarhus

Brief Summary

Background: Chronic Idiopathic Hyperventilation (CIH) is a form of dysfunctional breathing which has proven hard to treat effectively. The investigators hypothesised that by periodically inducing normocapnia over several weeks, it would be possible to raise the normal resting level/set point of CO2 and achieve a reduction of symptoms.

Methods: Six CIH patients were treated two hours a day for four weeks with a novel breathing mask. The mask was used to induce normocapnia in these chronically hypocapnic patients.

Capillary blood gases (PcCO2, pH, Standard Base Excess (SBE) etc.) were measured at baseline and once each week at least three hours after mask use, as well as spirometric values, breath holding tolerance and hyperventilation symptoms as per the Nijmegen Questionnaire (NQ),.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-04-10
• Study First Posted: 2012-04-11
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-18
• Last Update Posted: 2016-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Chronic idiopathic hyperventilation, i.e.:

• PCO2 level below 4.7 kPa AND
• SBE value more negative than -1.0

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Exclusion Criteria

• Oxygen saturation of 95% or lower at rest

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Partial Rebreathing Mask	Partial Rebreathing Mask	A novel membrane breathing mask which facilitates a partial rebreathing of expired gas (thereby raising systemic CO2), while allowing a diffusion of oxygen from the atmosphere to the user, through the membranes.

Primary Outcome Measures

Name	Time	Method
Blood gas and acid/base status	Once every week in the treatment period of four weeks	pH, PCO2, PO2, Standard Base Excess

Secondary Outcome Measures

Name	Time	Method
Hyperventilation symptoms	once a week	Nijmegen Questionnaire
Breath Hold Tolerance	once a week
Spirometric values	once a week	FEV1, FVC

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark