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Evaluation of the Impact of Telemedicine in Pediatric Intensive Care Units

Evaluation of the Impact of Telemedicine Use on Clinical Care Indicators in Pediatric Intensive Care Units: Cluster Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05260710
Enrollment
1760
Registered
2022-03-02
Start date
2022-04-01
Completion date
2023-12-31
Last updated
2022-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent, Critical Care, Intensive Care Units, Pediatric, Pediatric, Telemedicine

Keywords

Telemedicine, Pediatric Intensive Care Units, Randomized Controlled Clinical Trial, Technology

Brief summary

This study will be a cluster randomized controlled trial to assess the impact of telemedicine in Pediatric Intensive Care Units (PICU), through daily tele-rounds with a board certified physician and educational activities, in improving clinical-assistance indicators, as well as reducing the length of stay in the PICU.

Detailed description

This is a parallel cluster randomized controlled trial in pediatric intensive care units in Brazil. PICUs is the unit of randomization. All patients admitted to the PICUs selected to participate in the project will be included in the study allocated to the control or intervention group as their respective hospitals are randomized. Intervention group: Tele-rounds are case discussions with remote pediatric intensive care physicians and physicians from other specialties, such as a radiologist, infectious disease specialist, for the debate on conducts based on the best scientific evidence. Additionally, concurrently with the period of application of the intervention, continuing education activities will be made available to all professionals from the teams of the participating centers. Education activities are held monthly and consist of video classes and discussions of complex cases. Control group: This group will maintain the usual care offered by the participating centers.

Interventions

Tele-Critical Care: 1) establishing a diagnosis 2) guiding the therapeutic approach and 3) performing clinical follow-up. Physicians will discuss all patients in the unit, bed by bed, evaluating the specific clinical situation of each hospitalized patient, according to the protocol developed by the study.The proposal is to maintain horizontal care (the patient is monitored from the 1st day of hospitalization until discharge) for all patients in the unit. \+ Continuing education activities: video classes and discussions of complex cases.

Sponsors

Hospital Moinhos de Vento
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label)

Eligibility

Sex/Gender
ALL
Age
29 Days to 18 Years
Healthy volunteers
No

Inclusion criteria

* All children admitted to the pediatric ICU aged ≥29 days and \<18 years * Length of stay of more than 8 hours and, in case of death, with a length of stay of more than 24 hours

Exclusion criteria

* Patients with incomplete medical records * Incomplete data in the institution's database * Patients whose guardians did not accept to participate in the study and/or who did not sign the informed consent form and the image use term.

Design outcomes

Primary

MeasureTime frameDescription
Lenght of stayFrom PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 daysTime until discharge from the Pediatric intensive care unit

Secondary

MeasureTime frameDescription
To measure PICU mortalityFrom PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 daysTo measure the mortality rate in PICUs
To check the days free from mechanical ventilationFrom PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 daysTo check the days free from mechanical ventilation of patients hospitalized in PICUs
To measure the time of use of vasoactive drugsFrom PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 daysTo measure the time of use of vasoactive drugs by patients hospitalized in PICUs
To measure the time of use of broad-spectrum antibioticsFrom PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 daysTo measure the time of use of broad-spectrum antibiotics in patients hospitalized in PICUs
To measure the time of use of sedation/analgesiaFrom PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 daysTo measure the time of use of sedation/analgesia in patients hospitalized in PICUs

Contacts

Primary ContactFelipe C Cabral
felipe.cabral@hmv.org.br+55 (51) 98464-4901
Backup ContactTaís C Moreira
tais.moreira@hmv.org.br+55 (51) 3537-8350

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026