Video Assisted Study of Salbutamol Response in Viral Wheezing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Salbutamol.
- Who it may be relevant to
- Registry conditions: Wheezing. Basic parameters: 6 months — 24 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The study is video assisted cross-over study evaluating the effect of inhaled salbutamol in wheeze in children 6-24 months old.
Detailed description
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.
Interventions
- Drug Salbutamol
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.
Primary outcome measures
- Change in modified RDAI [Time frame: Within 3 hours of study entry]
Secondary outcome measures (4)
- Change in saturation of peripheral oxygen [Time frame: Within 3 hours of study entry]
- Change in auscultation finding [Time frame: Within 3 hours of study entry]
- Change in the difficulty of the respiratory distress [Time frame: Within 3 hours of study entry]
- Machine-vision assisted analysis of respiratory status [Time frame: Within 3 hours of study entry]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-crossover
Study locations
Finland · 1 center
- Department of Pediatrics, Oulu University Hospital — Oulu
Identifiers
NCT: NCT06093152 · 223/2021 · FIMEA/2023/003954