Video Assisted Study of Salbutamol Response in Viral Wheezing
ConditionWheezing
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-24
SponsorUniversity of Oulu
About this trial
The study is video assisted cross-over study evaluating the effect of inhaled salbutamol in wheeze in children 6-24 months old.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Wheezing
Salbutamol-treatment in emergency department prescribed
Disqualifiers
Need for immediate resuscitation
Immediate transfer to ICU
Suspicion of pneumonia based on the auscultation finding
Suspicion of airway foreign body
Trial population
Participants are 6-24 months old children presenting to the emergency department for wheezing.
Trial design
Design model
Case-crossover
Time perspective
Prospective
Treatments tested in this trial
Salbutamol
DrugInhaled salbutamol (SABA, selective beta2-adrenergic receptor agonist) 0,1 mg 4-6 puffs 3-4 times every 20 minutes administered by OptiChamber holding chamber.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Before salbutamol0 interventions
Group B: After salbutamol1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Within 3 hours of study entrySecondary outcomes
1
Change in saturation of peripheral oxygen
Change in saturation measured immediately before and after the intervention.
Time frame
Within 3 hours of study entry2
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.
Time frame
Within 3 hours of study entry3
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.
Time frame
Within 3 hours of study entry4
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.
Time frame
Within 3 hours of study entrySponsors and contacts
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Source ClinicalTrials.gov