RESUMEN
INTRODUCTION: Telemedicine has shown promising results, allowing specialists to provide rapid and effective care in remote locations. However, to our knowledge, current evidence is not robust enough to prove the effectiveness of this tool. This cluster-randomized trial (CRT) aimed to evaluate the impact of telemedicine on clinical care indicators in pediatric intensive care units (PICUs). METHODS: An open-label CRT was conducted in 16 PICUs within the Brazilian public health system. The trial took place from August 2022 to December 2023 and compared an intervention group, which received telemedicine support, with a control group, which received usual PICU care. The primary outcome was the PICU length of stay. The main secondary outcomes were mortality rate and ventilator-free days. RESULTS: A total of 1393 participants were included, 657 in the control group and 736 in the intervention group. The mean PICU length of stay was 10.42 (SD, 10.71) days for the control group and 11.52 (SD, 10.80) days for the intervention group. The overall mean of ventilator-free days was 6.82 (SD, 7.71) days. Regarding mortality, 7.54% of participants died in total. No significant difference was found in the outcomes between the groups. CONCLUSION: Despite the potential benefits of telemedicine, its effective implementation in the Brazilian public health system faces considerable challenges, highlighting the continued importance of investigating and improving the role of telemedicine in pediatric critical care. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT05260710 and ReBEC - RBR-7×j4wyp.
RESUMEN
The objective of this study is to present the protocol of a cluster randomized clinical trial to be conducted through the TeleICU project - Qualification of Intensive Care by Telemedicine. The study will consist of a cluster randomized clinical trial, open label, in pediatric intensive care units, with an allocation ratio of 1:1, to compare the intervention group (support of Telemedicine for patients admitted to the pediatric intensive care unit) with a control group (pediatric intensive care unit usual care). The study proposed to select 16 pediatric intensive care units, including 100 participants per site, with a total of 1,600 participants. The intervention group will receive telerounds from Monday to Friday and will have specialists and continuing education activities available. The primary outcome measure will be the length of stay in the pediatric intensive care unit, defined as the difference between the date of discharge of the participant and the date of admission to the intensive care unit. The secondary outcomes will be mortality rate, invasive mechanical ventilation-free days, days using antibiotics, days using vasoactive drugs and days using sedoanalgesia. This study will be conducted in accordance with Resolution 466/12 of the National Health Council, with approval by the Research Ethics Committee of the institutions involved. The present study has the potential to reproduce studies on Telemedicine in intensive care and may make important contributions to care in intensive care units in Brazil and other settings. If Telemedicine shows positive clinical care results compared to conventional treatment, more pediatric patients may benefit. ClinicalTrials.gov registry: NCT05260710.
Asunto(s)
COVID-19 , Telemedicina , Humanos , Niño , SARS-CoV-2 , Hospitalización , Unidades de Cuidado Intensivo Pediátrico , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
ABSTRACT The objective of this study is to present the protocol of a cluster randomized clinical trial to be conducted through the TeleICU project - Qualification of Intensive Care by Telemedicine. The study will consist of a cluster randomized clinical trial, open label, in pediatric intensive care units, with an allocation ratio of 1:1, to compare the intervention group (support of Telemedicine for patients admitted to the pediatric intensive care unit) with a control group (pediatric intensive care unit usual care). The study proposed to select 16 pediatric intensive care units, including 100 participants per site, with a total of 1,600 participants. The intervention group will receive telerounds from Monday to Friday and will have specialists and continuing education activities available. The primary outcome measure will be the length of stay in the pediatric intensive care unit, defined as the difference between the date of discharge of the participant and the date of admission to the intensive care unit. The secondary outcomes will be mortality rate, invasive mechanical ventilation-free days, days using antibiotics, days using vasoactive drugs and days using sedoanalgesia. This study will be conducted in accordance with Resolution 466/12 of the National Health Council, with approval by the Research Ethics Committee of the institutions involved. The present study has the potential to reproduce studies on Telemedicine in intensive care and may make important contributions to care in intensive care units in Brazil and other settings. If Telemedicine shows positive clinical care results compared to conventional treatment, more pediatric patients may benefit. ClinicalTrials.gov registry: NCT05260710
RESUMO O objetivo deste estudo será apresentar o protocolo de um ensaio clínico randomizado em cluster a ser realizado por meio do projeto TeleUTI - Qualificação da Assistência em Terapia Intensiva por Telemedicina. O estudo consistirá em um ensaio clínico randomizado por cluster, open label, em unidades de terapia intensiva pediátricas, com proporção de alocação de 1:1, com o intuito de comparar o grupo de intervenção (apoio da telemedicina para os pacientes internados na unidade de terapia intensiva pediátrica) com um grupo controle (cuidados habituais da unidade de terapia intensiva pediátrica). O estudo se propõe a selecionar 16 unidades de terapia intensiva pediátricas, incluindo 100 participantes por local, com o total de 1.600 participantes. O grupo intervenção receberá telerounds de segunda-feira a sexta-feira e terá à disposição especialistas e atividades de educação continuada. O desfecho primário a ser avaliado será o tempo de permanência nas unidades de terapia intensiva pediátricas, definido pela diferença entre a data de alta do participante com a data de admissão na unidade de terapia intensiva. Os desfechos secundários serão: taxa de mortalidade; dias livres de ventilação mecânica, dias de uso de antibióticos, dias de uso de drogas vasoativas e dias de uso de sedoanalgesia. Este estudo será conduzido em conformidade com a resolução 466/12 do Conselho Nacional de Saúde, com aprovação pelo Comitê de Ética em Pesquisa das instituições hospitalares envolvidas. O trabalho tem o potencial de reproduzir estudos sobre Telemedicina em cuidados intensivos, podendo trazer contribuições importantes ao atendimento em unidades de terapia intensiva no Brasil e em outras realidades. Se a Telemedicina mostrar resultados clínicos assistenciais positivos em relação ao tratamento convencional, mais pacientes pediátricos poderão ser beneficiados. Registro ClinicalTrials.gov: NCT05260710