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Impedance Pneumography Measurement During Acute Airway Obstruction and Recovery Phase in Young Children

Completed
Conditions
Obstruction; Airway, With Asthma
Registration Number
NCT03488303
Lead Sponsor
Revenio Research
Brief Summary

The purpose of this study is to evaluate the association of signals recorded and analysed with Ventica® LFTS in infants and preschoolers during acute airway obstruction/asthma exacerbation and recovery thereof for changes in the IP-derived TBFV curves within and between nights.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
Inclusion Criteria
  • Age 1-7
  • Diagnosis of acute airway obstruction or asthma exacerbation requiring inpatient treatment
Exclusion Criteria
  • Need for an ICU treatment
  • Bronchiolitis
  • Pneumonia (not including viral infections)
  • Other cardiorespiratory or neurological chronic diseases or states that may significantly alter the overnight breathing pattern
  • Implanted or external active medical devices

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Association between clinical status and tidal breathing flow-volume (TBFV) curves2-4 nights while at ward

Assess the association between clinical status and changes in tidal breathing flow-volume (TBFV) curves measured overnight with Ventica(R) Lung Function Testing System

Secondary Outcome Measures
NameTimeMethod
Association between lung function and tidal breathing flow-volume (TBFV) curves2-4 nights while at ward and 2 + 2 nights after discharge from hospital

Assess the association between lung function (spirometry or oscillometry) and changes in tidal breathing flow-volume (TBFV) curves measured overnight with Ventica(R) Lung Function Testing System

Association between asthma control and tidal breathing flow-volume (TBFV) curves2 + 2 nights after discharge from hospital

Assess the association between asthma control (C-ACT questionnaire) and changes in tidal breathing flow-volume (TBFV) curves measured overnight with Ventica(R) Lung Function Testing System

Trial Locations

Locations (1)

Children's Hospital Srebrnjak

🇭🇷

Zagreb, Croatia

Children's Hospital Srebrnjak
🇭🇷Zagreb, Croatia

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