Clinical Trials Directory

Trials / Completed

CompletedNCT02881632

Pneumacare SLP Validation in Infants and in Clinical Bronchiolitis

Pneumacare SLP Validation in Infants and in Clinical Bronchiolitis: Validation of Structured Light Plethysmography (SLP) in Healthy Infants and in Infants With Clinical Bronchiolitis

Status
Completed
Phase
Study type
Observational
Enrollment
60 (actual)
Sponsor
University Hospitals of North Midlands NHS Trust · Academic / Other
Sex
All
Age
1 Minute – 2 Years
Healthy volunteers
Accepted

Summary

A cohort observational study to characterise baseline Structured Light Plethysmography (SLP) outputs in infants with bronchiolitis and examine response to treatment using the Thora3DiTM

Detailed description

Viral illness, particularly chest infection causing breathing difficulty in infants and children is the commonest reason for admission to hospital. At present, there are no objective measurements of the degree of breathing difficulty. This is because current objective tests of breathing difficulty requires the patient to cooperate and actively perform the tests. This is not possible in babies and very challenging in young children. SLP is a noncontact, effort independent technique for measuring the rate of breathing, the amount of chest expansion and the relative contribution of chest and abdomen to the work of breathing. Measuring these parameters which are known to vary with increasing breathing difficulty will allow us to make objective assessments of breathing difficulty. This study proposes to validate this technique in babies aged 02 years who are healthy and in babies with clinical viral bronchiolitis. The Investigators intend to demonstrate that the technique is feasible in this young age group and that the investigators will be able to demonstrate clinically valid differences between normal and ill babies and also demonstrate measurable differences with the evolution of the clinical illness.

Conditions

Interventions

TypeNameDescription
DEVICEStructured Light Plethysmography (SLP) - PneumscanBoth healthy infants and bronchiolitis infants will have their chest movements monitored using Structured Light Plethysmography (SLP) performed by a device (Thora-3 Di) using a projector and two cameras. A light pattern of black and white squares is projected on the child's chest and the cameras record how the shape of this pattern changes with breathing. A computer converts this information to show how the child's chest moves during breathing.

Timeline

Start date
2015-11-01
Primary completion
2016-03-01
Completion
2016-03-01
First posted
2016-08-29
Last updated
2016-08-29

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT02881632. Inclusion in this directory is not an endorsement.