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

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ClinicalTrials.gov Identifier: NCT03488303
Recruitment Status : Recruiting
First Posted : April 4, 2018
Last Update Posted : August 29, 2018
Sponsor:
Collaborator:
Children's Hospital Srebrnjak
Information provided by (Responsible Party):
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.

Condition or disease
Obstruction; Airway, With Asthma

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impedance Pneumography Measurement During Acute Airway Obstruction and Recovery Phase in Young Children
Actual Study Start Date : April 12, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Choking

Group/Cohort
Main group
Study has only one group



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Young children admitted to the ward at the hospital due to acute lower airway obstruction/asthma exacerbation.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03488303


Contacts
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Contact: Davor Plavec, MD, PhD +385 1 6391 100 plavec@bolnica-srebrnjak.hr

Locations
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Croatia
Children's Hospital Srebrnjak Recruiting
Zagreb, Croatia, 10000
Contact: Davor Plavec, MD, PhD    +385 1 6391 100    plavec@bolnica-srebrnjak.hr   
Sponsors and Collaborators
Revenio Research
Children's Hospital Srebrnjak
Investigators
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Principal Investigator: Davor Plavec, MD, PhD Children's Hospital Srebrnjak

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Responsible Party: Revenio Research
ClinicalTrials.gov Identifier: NCT03488303     History of Changes
Other Study ID Numbers: VCS-006
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases