Video Assisted Study of Salbutamol Response in Viral Wheezing (ViVi)

University of Oulu

Status: Enrolling

Conditions: Wheezing

Treatments: Drug: Salbutamol

Study type: Observational

Funder types: Other

Identifiers

NCT06093152

223/2021

FIMEA/2023/003954 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 6 to 24 months old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

Before salbutamol

Description:

Participants before the administration of salbutamol

After salbutamol

Description:

Participants after the administration of salbutamol

Treatment:

Drug: Salbutamol