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NCT Number: NCT06093152

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.

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Key information

Conditions

Wheezing Pathological Conditions, Signs and Symptoms Respiratory Sounds Signs and Symptoms Signs and Symptoms, Respiratory

Age range

6 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pediatrics, Oulu University Hospital

Oulu, 90130, Finland

Location status: Recruiting

Location contact

Minna Honkila, MD, PhD

SUB_INVESTIGATOR

Niko Paalanne, MD, PhD

SUB_INVESTIGATOR

Terhi Tapiainen, MD, PhD

CONTACT

[email protected]

+358-8-315 5185

Terhi Tapiainen, MD, PhD

PRINCIPAL_INVESTIGATOR

Tuomas Jartti, MD, PhD

SUB_INVESTIGATOR

Tytti Pokka, MSc

SUB_INVESTIGATOR

Ville Lindholm, MD

CONTACT

[email protected]

+35883155283

Ville Lindholm, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salbutamol

Drug

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.

Primary outcomes

  1. Change in modified RDAI

    Time frame: Within 3 hours of study entry

    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.

Secondary outcomes

  1. Change in saturation of peripheral oxygen

    Time frame: Within 3 hours of study entry

    Change in saturation measured immediately before and after the intervention.

  2. Change in auscultation finding

    Time frame: Within 3 hours of study entry

    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.

  3. Change in the difficulty of the respiratory distress

    Time frame: Within 3 hours of study entry

    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.

  4. Machine-vision assisted analysis of respiratory status

    Time frame: Within 3 hours of study entry

    Machine vision analysis of the difficulty of wheezing (none - mild - difficult). Assessed using videos collected immediately before and after the intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Ville Lindholm, MD

CONTACT

[email protected]

+35883155283

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Registry information

Acronym: ViVi

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 23, 2023
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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