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

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

Study Overview

• Status: Recruiting
• Conditions: Wheezing
• Intervention / Treatment: Drug: Salbutamol

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Ville Lindholm, MD; Phone Number: +35883155283; Email: Ville.a.lindholm@oulu.fi

Study Locations

• Finland
  • Oulu, Finland, 90130
    • Recruiting
    • Department of Pediatrics, Oulu University Hospital
    • Contact: Terhi Tapiainen, MD, PhD; Phone Number: +358-8-315 5185; Email: terhi.tapiainen@oulu.fi
    • Principal Investigator: Terhi Tapiainen, MD, PhD
    • Sub-Investigator: Niko Paalanne, MD, PhD
    • Sub-Investigator: Tytti Pokka, MSc
    • Sub-Investigator: Ville Lindholm, MD
    • Sub-Investigator: Minna Honkila, MD, PhD
    • Sub-Investigator: Tuomas Jartti, MD, PhD
    • Contact: Ville Lindholm, MD; Phone Number: +35883155283; Email: Ville.a.lindholm@student.oulu.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Participants are 6-24 months old children presenting to the emergency department for wheezing.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Before salbutamol; Participants before the administration of salbutamol
After salbutamol; Participants after the administration of salbutamol	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in saturation of peripheral oxygen	Change in saturation measured immediately before and after the intervention.	Within 3 hours of study entry
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
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
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

Collaborators and Investigators

• Sponsor: University of Oulu
• Investigators: Principal Investigator: Terhi Tapiainen, Professor, University of Oulu

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 5, 2022
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol
• Other Study ID Numbers: 223/2021; FIMEA/2023/003954 (Other Identifier: FIMEA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No