Abstract
Crit Care Sci. 2023;35(3):266-272
DOI 10.5935/2965-2774.20230223-pt
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
Abstract
Rev Bras Ter Intensiva. 2022;34(1):87-95
DOI 10.5935/0103-507x.20220003-en
The TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE) trial aims to assess whether a complex telemedicine intervention in intensive care units, which focuses on daily multidisciplinary rounds performed by remote intensivists, will reduce intensive care unit length of stay compared to usual care.
The TELESCOPE trial is a national, multicenter, controlled, open label, cluster randomized trial. The study tests the effectiveness of daily multidisciplinary rounds conducted by an intensivist through telemedicine in Brazilian intensive care units. The protocol was approved by the local Research Ethics Committee of the coordinating study center and by the local Research Ethics Committee from each of the 30 intensive care units, following Brazilian legislation. The trial is registered with ClinicalTrials. gov (NCT03920501). The primary outcome is intensive care unit length of stay, which will be analyzed accounting for the baseline period and cluster structure of the data and adjusted by prespecified covariates. Secondary exploratory outcomes included intensive care unit performance classification, in-hospital mortality, incidence of nosocomial infections, ventilator-free days at 28 days, rate of patients receiving oral or enteral feeding, rate of patients under light sedation or alert and calm, and rate of patients under normoxemia.
According to the trial’s best practice, we report our statistical analysis prior to locking the database and beginning analyses. We anticipate that this reporting practice will prevent analysis bias and improve the interpretation of the reported results.