Video Assisted Study of Salbutamol Response in Viral Wheezing
NCT ID: NCT06093152
Last Updated: 2025-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2023-10-23
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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Before salbutamol
Participants before the administration of salbutamol
No interventions assigned to this group
After salbutamol
Participants after the administration of salbutamol
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Salbutamol-treatment in emergency department prescribed
Exclusion Criteria
* Immediate transfer to ICU
* Suspicion of pneumonia based on the auscultation finding
* Suspicion of airway foreign body
6 Months
24 Months
ALL
No
Sponsors
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University of Oulu
OTHER
Responsible Party
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Terhi Tapiainen
Professor of Pediatrics, Head of Pediatric Infectious Diseases and Emergency Department
Principal Investigators
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Terhi Tapiainen, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Oulu
Locations
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Department of Pediatrics, Oulu University Hospital
Oulu, , Finland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FIMEA/2023/003954
Identifier Type: OTHER
Identifier Source: secondary_id
223/2021
Identifier Type: -
Identifier Source: org_study_id
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