Video Assisted Study of Salbutamol Response in Viral Wheezing

Wheezing Clinical Trial

— ViVi  

Official title:

Video Assisted Study of Salbutamol Response in Viral Wheezing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06093152
• Other study ID #: 223/2021
• Secondary ID: FIMEA/2023/00395
• Status: Recruiting
• Start date: October 23, 2023
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: University of Oulu
• Contact: Ville Lindholm, MD
• Phone: +35883155283
• Email: Ville.a.lindholm[@]oulu.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Respiratory Sounds
• Wheezing

Intervention

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.

Locations

Country	Name	City	State
Finland	Department of Pediatrics, Oulu University Hospital	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

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