Wheezing Clinical Trial
— ViViOfficial title:
Video Assisted Study of Salbutamol Response in Viral Wheezing
The study is video assisted cross-over study evaluating the effect of inhaled salbutamol in wheeze in children 6-24 months old.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 24 Months |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Finland | Department of Pediatrics, Oulu University Hospital | Oulu |
Lead Sponsor | Collaborator |
---|---|
University of Oulu |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in saturation of peripheral oxygen | Change in saturation measured immediately before and after the intervention. | Within 3 hours of study entry | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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