Structured Light Plethysmography in Obstructive Airways Disease

NCT03499938 | Completed

• 1 other identifier: 237151
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Respiratory Diseases

Keywords

Asthma; Bronchiolitis; Wheezing; Structured Light Plethysmography

Outcome Measures

Primary Outcomes (1)

• Clinical severity of breathing distress measured by modified pulmonary index score (mPIS)

  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

  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.

Secondary Outcomes (2)

• 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.

Other Outcomes (1)

• Clinical outcome (Length of stay)

  Length of stay is calculated as time from hospital admission (entering the primary ward) to time of hospital discharge (leaving the final ward). The estimated length of hospital stay will be a minimum of 1 and maximum of 30 days.

Interventions

Structured Light Plethysmography DEVICE

Non-invasive non-contact measurement of tidal breathing during hospital admission

Eligibility Criteria

• Age: 1 Month - 12 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children admitted to paediatric HDU/ICU wards for acute obstructive airways disease aged 1 month to 12 years

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• Pneumacare Ltd: collaborator
• University of Cambridge: collaborator

Study Sites (1)

Evelina London Children´s Hospital

London, SE1 7EH, United Kingdom

Location

Related Links

• P88 Structured light plethysmography in toddlers admitted due to acute wheezing
• Using Adaptive Principal Component Analysis (APCA) and Machine Learning to characterise paediatric asthma in data collected by Structured Light Plethysmography (SLP) \| European Respiratory Society

MeSH Terms

Conditions

Asthma; Bronchiolitis; Respiratory Sounds

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchitis; Respiratory Tract Infections; Infections; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Iles, Dr

  Guy´s and St Thomas´ NHS trust

  STUDY DIRECTOR

• Eero Lauhkonen, Dr

  Guy´s and St Thomas´ NHS trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 17, 2018
• Study Start: June 11, 2018
• Primary Completion: December 11, 2018
• Study Completion: December 11, 2018
• Last Updated: February 18, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)