Structured Light Plethysmography in Children Admitted Due to Acute Obstructive Airways Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Clinical severity of breathing distress measured by modified pulmonary index score (mPIS)
Study Overview
Brief Summary
Obstructive airways disease is the most common group of acute illnesses leading to hospital treatment in children. This group consists of different age-related diagnoses, such as bronchiolitis in infants or wheezing and asthma in older children. Though these entities overlap with each other, they have common characteristics and the same leading symptom breathing distress.
The investigators aim conduct an observational cohort study to examine if the clinical course of respiratory distress be quantified and the treatment improved in children with acute breathing difficulty using a new non-touch non-invasive SLP measurement device?
Thora3Di is a new CE- and FDA-approved medical device able to measure chest and abdominal wall movements during tidal breathing with a method called structured light plethysmography (SLP). The method is non-touch and non- invasive, it does not need any connection with the child.
One-month- to 12-years-old infants and children are recruited from the paediatric wards at Evelina London Children's hospital. The child lies or sits within the field of vision of the SLP device with their chest and abdomen exposed. A grid pattern of normal light will be projected onto the chest and changes in the format of the grid as the infant or child breathes will be recorded by the SLP device. Data will be collected for each child for 3-5 minutes once in 24 hour periods for 2-10 times during hospital stay.
The aim is to reduce duration of hospital stay by finding predicting parameters for obstructive airways diseases with the new SLP method, and further aim to standardization of treatment strategies, to reduce expenditure.
Detailed Description
Cohort pilot study to characterise the chest wall movement during tidal breathing in children admitted due to acute obstructive airways disease, using non-invasive SLP methodology (Thora3DiTM).
The investigators propose to utilise the SLP in children admitted for obstructive airways disease and track progression of their condition during the hospital stay. Focus will be in the SLP output, and investigators aim to 1) quantify the breathing distress and whether this number has an effect on the patient outcome and 2) further aim to see if regional changes in the thoracic-abdominal movement can be recognized by the measurement method.
The data collected from this study will allow investigators to characterise chest wall movements in children with obstructive airways disease and to examine the effect of the treatment on this movement.
Study population
Investigators will aim to recruit:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Month to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 1 month to 12 years
- •Any children who have been admitted to ELCH with a diagnosis of acute obstructive airways disease within 24 hours
- •Weight over 3 kg
Exclusion Criteria
- •Weight less than 3kg
- •History of thoracic or abdominal surgery, or any acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to participate in the study
- •Patients with significant co-morbidities resulting in clinical instability (assessed by the clinician at screening only), such as diaphramatic dysfunction, tracheostomy or need for non-invasive or invasive ventilation
Outcomes
Primary Outcomes
Clinical severity of breathing distress measured by modified pulmonary index score (mPIS)
Time Frame: Change in clinical severity score during hospital admission. Data will be collected for each child once in 24 hour periods for 2-10 times during hospital stay.
To examine whether SLP can predict clinical severity, the relationship between SLP tidal breathing parameters and clinical score (mPIS is a composite score from RR, HR, Sat02, Wheezing, Accessory muscle use, Inhalation-Exhalation-ratio) will be assessed. For each of these 6 measurements or observations, a score of 0 to 3 is assigned, resulting in a possible minimum score of 0 and a maximum score of 18. A cut-off score of 12 has been studied to distinguish more severe asthmatic exacerbation in children. (Carrol et al 2005) Primary outcome measure: mPIS
Secondary Outcomes
- Regional SLP tidal breathing parameters (relative contribution)(Change in SLP relative contribution during hospital admission. Data will be collected for each child once in 24 hour periods for 2-10 times during hospital stay.)
- Regional SLP tidal breathing parameters (phase)(Change in SLP phase during hospital admission. Data will be collected for each child once in 24 hour periods for 2-10 times during hospital stay.)