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Lung Clearance Index (LCI) in Pediatric Patients With Obstructive Lung Disease

NCT02950116 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2017-06-20

No results posted yet for this study

Summary

Chronic respiratory diseases (CRDs) affect the airways and other structures of the lungs and thereby lead to ventilation inhomogeneity. The most common CRDs in children are asthma, bronchiectasis and cystic fibrosis (CF). All three are obstructive diseases. However, while asthma is mostly characterized by obstruction due to bronchoconstriction of the airways, obstruction in bronchiectasis and CF originates primarily from mucus retention due to abnormal airway clearance mechanisms.

The Nitrogen Multiple Breath Washout test (N2-MBW-test) is a robust and sensitive detector of early pulmonary changes and ventilation inhomogeneity. The minimal cooperation which is required for this test makes it very convenient for use in any age category.

Research on LCI described it as a reliable indicator of obstructive lung disease in pediatric CF patients as from 6 years of age. Whether LCI is a reliable parameter for early lung disease in asthma children is less clearly demonstrated. No data were found on LCI calculated from the N2-MBW-test in children with bronchiectasis.

Conditions

Interventions

DEVICE

Perform three multiple breath nitrogen washout tests (N2-MBW-test)

* Patient is sitting in upright position, nose clip in place and breathing through a mouth piece with filter (neither sitting forward with back bent, nor supporting arms such that shoulders are raised) * Patient's breathing pattern is stable for a minimum of 5 breaths * Start of washout by inhaling 100% oxygen (initiated by lab technician) * Continuous stable breathing pattern until end of washout test * End target = 1/40th of start N2 concentration * To ensure end of washout is achieved, patients should breathe 5 more breaths below the target concentration before the trial is terminated * Three N2-MBW-tests are performed consecutively. Time between each test is \[duration of the previous test\*1.5\] (e.g. test duration = 6 min., time to next test = 6\*1.5 = 9 min.)

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    lead OTHER

Principal Investigators

  • Hanneke Eyns, MSc, PT · UZ Brussel Laarbeeklaan 101 1090 Brussels Belgium

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-09
Primary Completion
2017-03-31
Completion
2017-04-07

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02950116 on ClinicalTrials.gov