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Structured Light Plethysmography in Obstructive Airways Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03499938
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : February 18, 2020
Sponsor:
Collaborators:
Pneumacare Ltd
University of Cambridge
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

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.


Condition or disease Intervention/treatment
Pediatric Respiratory Diseases Device: Structured Light Plethysmography

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Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Structured Light Plethysmography in Children Admitted Due to Acute Obstructive Airways Disease
Actual Study Start Date : June 11, 2018
Actual Primary Completion Date : December 11, 2018
Actual Study Completion Date : December 11, 2018

Intervention Details:
  • Device: Structured Light Plethysmography
    Non-invasive non-contact measurement of tidal breathing during hospital admission


Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Regional SLP tidal breathing parameters (relative contribution) [ Time Frame: 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. ]
    To characterise regional thoraco-abdominal movements in children with obstructive airways disease and to examine the effect of standard treatment procedures on this movement. Primary Outcome measure: Regional SLP tidal breathing parameter (relative contribution)

  2. Regional SLP tidal breathing parameters (phase) [ Time Frame: 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. ]
    To characterise regional thoraco-abdominal movements in children with obstructive airways disease and to examine the effect of standard treatment procedures on this movement. Primary Outcome measure: Regional SLP tidal breathing parameter (phase).


Other Outcome Measures:
  1. Clinical outcome (Length of stay) [ Time Frame: 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. ]
    To examine whether tidal breathing patterns can predict clinical outcome, the relationship between SLP tidal breathing parameters and clinical outcome (as measured by length of hospital stay [LOS]) will be assessed. Primary outcome measures: LOS



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Ages Eligible for Study:   1 Month to 12 Years   (Child)
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499938


Locations
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United Kingdom
Evelina London Children´s Hospital
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Pneumacare Ltd
University of Cambridge
Investigators
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Study Director: Richard Iles, Dr Guy´s and St Thomas´ NHS trust
Principal Investigator: Eero Lauhkonen, Dr Guy´s and St Thomas´ NHS trust

Additional Information:
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03499938    
Other Study ID Numbers: 237151
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Asthma
Bronchiolitis
Wheezing
Structured Light Plethysmography
Additional relevant MeSH terms:
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Respiration Disorders
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases