Obstruction; Airway, With Asthma Clinical Trial
Official title:
Impedance Pneumography Measurement During Acute Airway Obstruction and Recovery Phase in Young Children
| NCT number | NCT03488303 |
| Other study ID # | VCS-006 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 12, 2018 |
| Est. completion date | December 20, 2018 |
| Verified date | May 2019 |
| Source | Revenio Research |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | December 20, 2018 |
| Est. primary completion date | December 20, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Year to 7 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Croatia | Children's Hospital Srebrnjak | Zagreb |
| Lead Sponsor | Collaborator |
|---|---|
| Revenio Research | Children's Hospital Srebrnjak |
Croatia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Association between clinical status and tidal breathing flow-volume (TBFV) curves | Assess the association between clinical status and changes in tidal breathing flow-volume (TBFV) curves measured overnight with Ventica(R) Lung Function Testing System | 2-4 nights while at ward | |
| Secondary | Association between lung function and tidal breathing flow-volume (TBFV) curves | 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 | 2-4 nights while at ward and 2 + 2 nights after discharge from hospital | |
| Secondary | Association between asthma control and tidal breathing flow-volume (TBFV) curves | 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 | 2 + 2 nights after discharge from hospital |