Table 1

Synopsis (WHO trial registration data set, as originally submitted)

Data categoryInformation
Primary register and identification numberClinicalTrials.gov—NCT03920501
Date of first registration19 April 2019
Secondary identification numbersPROADI 25000.018804/2018–2023
Development agency/funding sourceMinistry of Health (Institutional Development Programme of the Unified Health System)
Primary sponsorMinistry of Health
Secondary sponsorHospital Israelita Albert Einstein
General contactDN, MD, PhD. Phone: (+55) 11 96 490–7494, e-mail: danilo.noritomi@einstein.br
Academic contactDN, MD, PhD. Phone: (+55) 11 96 490–7494, e-mail: danilo.noritomi@einstein.br
Public titleThe influence of telemedicine in the treatment of intensive care unit (ICU) patients.
Academic titleMulticentric, controlled, cluster-randomised superiority study to evaluate the effectiveness of specialist assistance via Telemedicine in patients admitted to ICUs in Brazilian hospitals.
Countries involved in recruitmentBrazil
Health conditions/ problems studiedICU care design, critically ill patients, Telemedicine.
InterventionsComparator: use of Telemedicine (intensivists) in daily ICU multidisciplinary rounds and quality indicators management (audit and feedback)
Control: ICUs in the same strata, with no intervention
Main inclusion and exclusion criteriaICU clusters (all adult patients admitted after the beginning of the study will be included, with the exception of those admitted for non-medical reasons)
Age: ≥18 years old
Sex: both
Accepts volunteers: no
Inclusion criteria for units: public Hospital ICUs with a minimum of eight hospital beds interested and committed to participating in the study.
Exclusion criteria for units: units with fully established daily multidisciplinary rounds by an intensivist, specialised units (such as ICUs admitting exclusively cardiac surgical or neurological patients) or step-down units.
Type of studyIntervention/cluster
Allocation: randomisation stratified by patients’ previous ICU length of stay
Intervention design: parallel assignment
Masking: Open
Primary purpose: Quality improvement
Expected date of first inclusionFebruary 2019
Sample size30 clusters (15 in each group), approximately 15 000 patients
Recruitment statusNot initiated (expected for 2019)
Primary outcomeLength of stay in the ICU (days)
Secondary outcomes

  •  Classification based on the association between standardised mortality ratio and standardised resource use

  •  Rate per patient per day receiving oral or enteral nutrition

  •  Rate per patient per day in appropriate sedation (RASS=−3 to +1)

  •  Rate of normoxic patients on oxygen therapy (92% ≥SpO2≥96%)

  •  Time without mechanical ventilation (MV) in 28 days

  •  Duration of CVC use

  •  Duration of vesical delayed probe use

  •  Incidence of central line-associated bloodstream infection) (43)

  •  Incidence of ventilator-associated pneumonia (44)

  •  Incidence of catheter-associated urinary tract infection (45)

  •  Hospital mortality

  • CVC, central venous catheter; RASS, Richmond Agitation-Sedation Scale; SPO2, oxygen saturation.