Intensive care telemedicine versus need-based telephone consultation in pediatric patients with respiratory syncytial virus bronchiolitis: multicenter randomized open-label clinical trial

Abstract

BACKGROUND: Bronchiolitis is a common infection of the lower respiratory tract among the pediatric population, representing a major cause of hospitalization. Patients from regional hospitals often require intensive care support and so the assistance from referral centers. The inter – hospital transferring, during the peak infection period, takes around 24 – 48 hours due to pediatric ambulances saturation. The assistance by an intensivist through telemedicine during this time interval would minimize the territorial differences nowadays existing and therefore, avoid the delay of the treatment. OBJECTIVES: Our main objective is to decrease the length of stay of critically ill patients with RSV bronchiolitis from regional hospitals with telemedicine intensivist support meanwhile they are not transferred to referral centers. DESIGN: A prospective randomized, controlled, multicentered, open-label clinical trial performed in regional and referral hospitals from Girona, Tarragona and, Terres de l’Ebre Health region. PARTICIPANTS: Participants included in the clinical trial are patients under 12 months old diagnosed with RSV bronchiolitis from the regional hospital with criteria to be transferred to the referral center. A consecutive non-probabilistic model will be used. METHODS: The study will include 168 participants, 84 will be assisted through need – based telephone consultation and the other 84 will receive telemedicine intensivist support from the referral center during the period the patient cannot be transferred from the regional hospital because there are no ambulances available. Data about the length of stay, clinical complications, provider satisfaction, economic cost, and covariables will be collected and statistically analyzed to avoid confounding factors