Pneumacare SLP Validation in Infants and in Clinical Bronchiolitis

University Hospitals of North Midlands NHS Trust

Status: Completed

Conditions: Bronchiolitis

Treatments: Device: Structured Light Plethysmography (SLP) - Pneumscan

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02881632

836

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 1 minute to 2 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Aged between 0 and 1 years
• Doctor diagnosis of AVB
• Admitted to hospital within last 24hrs (AVB participants only)
• Or healthy term infant aged up to 2yrs with no current respiratory illness

Exclusion Criteria:

• Patients with significant co morbidities resulting in clinical instability (assessed by the clinician at screening only):
• An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to participate in the study
• Parents unable to consent/comply with trial protocol
• An inpatient for over 24hrs (AVB patients only)

Trial design

60 participants in 2 patient groups

Healthy infants aged 0-2

Description:

Healthy infants aged 0-2 year with no respiratory diseases to provide a reference values. A structured light pattern (Structured Light Plethysmography (SLP) - Pneumscan) will be projected onto the chest and abdominal wall and the movement of this pattern as the patient breathes will be recorded for 2 min. The total period of testing per session should take approximately 30 minutes per person.

Treatment:

Device: Structured Light Plethysmography (SLP) - Pneumscan

Infants aged 0-1 with Bronchiolitis

Description:

Infants admitted to hospital within last 24hrs (AVB participants only). A structured light pattern (Structured Light Plethysmography (SLP) - Pneumscan) will be projected onto the chest and abdominal wall and the movement of this pattern as the patient breathes will be recorded for 2 min. The total period of testing per session should take approximately 30 minutes per person

Treatment:

Device: Structured Light Plethysmography (SLP) - Pneumscan