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

Study Timeline

• Study First Submitted: 2018-03-28
• Study First Submitted QC: 2018-03-28
• Study First Posted: 2018-04-04
• Study Start: 2018-04-12
• Primary Completion: 2018-12-20
• Study Completion: 2018-12-20
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-20
• Last Update Posted: 2019-05-21

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

Name	Time	Method
Association between clinical status and tidal breathing flow-volume (TBFV) curves	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 Outcome Measures

Name	Time	Method
Association between lung function and tidal breathing flow-volume (TBFV) curves	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
Association between asthma control and tidal breathing flow-volume (TBFV) curves	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

Trial Locations

Locations (1)

Children's Hospital Srebrnjak; 🇭🇷 Zagreb, Croatia