Pneumacare SLP Validation in Infants and in Clinical Bronchiolitis
- Conditions
- Bronchiolitis
- Interventions
- Device: Structured Light Plethysmography (SLP) - Pneumscan
- Registration Number
- NCT02881632
- Lead Sponsor
- University Hospitals of North Midlands NHS Trust
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Healthy infants aged 0-2 Structured Light Plethysmography (SLP) - Pneumscan 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. Infants aged 0-1 with Bronchiolitis Structured Light Plethysmography (SLP) - Pneumscan 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
- Primary Outcome Measures
Name Time Method Difference in SLP measurements between infants. Measured upto 7 days Difference in SLP measurements between infants. SLP provides a measure of the chest and abdominal movement (Respiratory effort) of the subjects, the movement signal will be used to quantify clinically relevant tidal breathing parameters such as timing indices: Ti (Time of inspiration), Te ( Time of expiration) and Ttot (Ti+Te). Parameters will be quantified for each recorded SLP signal (averaged) from each infant, and then used to compare between infants with bronchiolitis and healthy babies.
- Secondary Outcome Measures
Name Time Method Changes in SLP measurements in infants given additional breathing support. Measured upto 7 days Changes in SLP measurements in infants during their clinical course in hospital who are given additional breathing support. SLP provides a measure of the chest and abdominal movement (Respiratory effort) of the subjects, the movement signal will be used to quantify clinically relevant tidal breathing parameters such as timing indices: Ti (Time of inspiration), Te ( Time of expiration) and Ttot (Ti+Te). For each subject SLP was recorded on a daily basis, this will allow the comparison between the parameters within subject to check the progression of the disease with time.
Changes in SLP measurements in infants during their clinical course. Measured upto 7 days Changes in SLP measurements in infants during their clinical course in hospital. SLP provides a measure of the chest and abdominal movement (Respiratory effort) of the subjects, the movement signal will be used to quantify clinically relevant tidal breathing parameters such as timing indices: Ti (Time of inspiration), Te ( Time of expiration) and Ttot (Ti+Te). For each subject SLP was recorded on a daily basis, this will allow the comparison between the parameters within subject to check the progression of the disease with time
Trial Locations
- Locations (1)
University Hospitals of North Midlands NHS Trust
🇬🇧Stoke-on-Trent, Staffordshire, United Kingdom