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Completed

NCT Number: NCT03488303

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

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.

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Key information

Conditions

Obstruction; Airway, With Asthma Bites and Stings Chemically-Induced Disorders Poisoning Wounds and Injuries

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Srebrnjak

Zagreb, 10000, Croatia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Association between clinical status and tidal breathing flow-volume (TBFV) curves

    Time frame: 2-4 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 outcomes

  1. Association between lung function and tidal breathing flow-volume (TBFV) curves

    Time frame: 2-4 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

  2. Association between asthma control and tidal breathing flow-volume (TBFV) curves

    Time frame: 2 + 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

Sponsors and collaborators

Lead sponsor

Revenio Research

Industry

Collaborators

  • Children's Hospital Srebrnjak

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 4, 2018
Registry last updated
May 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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