Skip to main content

Table 2 Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) secondary outcome variables

From: Methods in the design and implementation of the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) clinical trial

 • Time to recovery of acute respiratory failure (from endotracheal intubation to first meeting criteria to be tested for extubation readiness)

 • Duration of weaning from mechanical ventilation (from first meeting criteria to be tested for extubation readiness to first successful extubation – defined as extubation for more than 24 h)

 • Occurrence of adverse events: inadequate pain management, inadequate sedation management, clinically significant iatrogenic withdrawal symptoms, unplanned extubation, airway irritation from movement of the endotracheal tube within the airway, extubation failure/reintubation within 24 h of extubation, dislodgement of vascular access or drainage tubes, ventilator-associated pneumonia (VAP)a, catheter-associated blood stream infection (CA-BSI)a, and stage 2+ pressure ulcers. Report of a new critical airway will be assessed through hospital discharge or day 90 (whichever occurs first)

 • Detection of life-threatening neurological events

 • Occurrence of iatrogenic withdrawal symptoms

 • PICU and hospital LOS

 • Hospital costs

 • Protocol implementation costs

 • Cost-effectiveness

 • In-hospital mortality

 • Post-discharge quality of life and emotional health

  1. aThe National Nosocomial Infections Surveillance System (NNIS) definitions will be used to define VAP and CA-BSI. All cases of VAP and CA-BSI will be adjudicated by a process outlined by Cook et al. [47]. LOS length of stay, PICU pediatric intensive care unit