Video Assisted Study of Salbutamol Response in Viral Wheezing

Study Overview
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Brief Summary
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The study is video assisted cross-over study evaluating the effect of inhaled salbutamol in wheeze in children 6-24 months old.

Detailed Description
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The object of the study is to evaluate the effect of inhaled salbutamol in wheeze in children 6-24 months old. In despite of the lack of evidence of salbutamol, it is considered the gold standard in acute wheezing. Placebo-controlled study would be unethical so all participants are treated with salbutamol based on current guidelines. Instead, participants serve as control subjects of their own which is executed by a type video assisted cross-over study. Participants are filmed before and after the treatment. Afterwards a panel of pediatricians not participating in the treatment of the participants independently evaluates the difficulty of the wheeze. Videos are randomly arranged and members of the panel are blinded to the time point (before/after) of videos. In addition, collected videos are analyzed using machine vision. Biosignals are collected from the videos and evaluated using algorithms in order to show that machine vision can be utilized to evaluate the difficulty of wheezing. The machine vision analysis is compared to the evaluation of the panel of pediatricians.

Official Title
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Video Assisted Study of Salbutamol Response in Viral Wheezing

Conditions
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Wheezing

Intervention / Treatment
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* Drug: Salbutamol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Wheezing Salbutamol-treatment in emergency department prescribed Exclusion Criteria: Need for immediate resuscitation Immediate transfer to ICU Suspicion of pneumonia based on the auscultation finding Suspicion of airway foreign body

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Before salbutamol<br>Participants before the administration of salbutamol | |
| After salbutamol<br>Participants after the administration of salbutamol | Drug: Salbutamol<br>* Inhaled salbutamol (SABA, selective beta2-adrenergic receptor agonist) 0,1 mg 4-6 puffs 3-4 times every 20 minutes administered by OptiChamber holding chamber.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in modified RDAI | RDAI = Respiratory Distress Assessment Instrument, modified to not include auscultation findings. Range 0-18. Higher score indicates more difficult respiratory distress. Evaluated by the blinded panel afterwards using collected videos. Videos collected immediately before and after the intervention. | Within 3 hours of study entry | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in saturation of peripheral oxygen | Change in saturation measured immediately before and after the intervention. | Within 3 hours of study entry | 
| Change in auscultation finding | Evaluated by review of medical records (i.e. based on the findings of the physician treating the patient). Assessed as difficult (wheezing lasting all expiration and possibly inspiration in all 4 lung fields), medium (no inspiratory wheezing, lasting all expiratory OR in all lung 4 fields) of mild (no inspiratory wheezing, wheezing not lasting all expiratory and not in all lung fields). Assessed immediately before and after the intervention. | Within 3 hours of study entry | 
| Change in the difficulty of the respiratory distress | Subjective evaluation of the respiratory distress based on the appearance of the patient on the video. Range 0-10, higher score indicating more difficult respiratory distress. Assessed by the blinded panel afterwards using videos collected immediately before and after the intervention. | Within 3 hours of study entry | 
| Machine-vision assisted analysis of respiratory status | Machine vision analysis of the difficulty of wheezing (none - mild - difficult). Assessed using videos collected immediately before and after the intervention. | Within 3 hours of study entry |