Automated closed–loop FiO2 titration increases the percentage of time spent in optimal zones of oxygen saturation in pediatric patients–A randomized crossover clinical trial

Abstract

IntroductionWe aimed to compare automated ventilation with closed–loop control of the fraction of inspired oxygen (FiO2) to automated ventilation with manual titrations of the FiO2 with respect to time spent in predefined pulse oximetry (SpO2) zones in pediatric critically ill patients.MethodsThis was a randomized crossover clinical trial comparing Adaptive Support Ventilation (ASV) 1.1 with use of a closed–loop FiO2 system vs. ASV 1.1 with manual FiO2 titrations. The primary endpoint was the percentage of time spent in optimal SpO2 zones. Secondary endpoints included the percentage of time spent in acceptable, suboptimal and unacceptable SpO2 zones, and the total number of FiO2 changes per patient.ResultsWe included 30 children with a median age of 21 (11–48) months; 12 (40%) children had pediatric ARDS. The percentage of time spent in optimal SpO2 zones increased with use of the closed–loop FiO2 controller vs. manual oxygen control [96.1 (93.7–98.6) vs. 78.4 (51.3–94.8); P < 0.001]. The percentage of time spent in acceptable, suboptimal and unacceptable zones decreased. Findings were similar with the use of closed-loop FiO2 controller compared to manual titration in patients with ARDS [95.9 (81.6–98.8) vs. 78 (49.5–94.8) %; P = 0.027]. The total number of closed-loop FiO2 changes per patient was 52 (11.8–67), vs. the number of manual changes 1 (0–2), (P < 0.001).ConclusionIn this randomized crossover trial in pediatric critically ill patients under invasive ventilation with ASV, use of a closed–loop control of FiO2 titration increased the percentage of time spent within in optimal SpO2 zones, and increased the total number of FiO2 changes per patient.Clinical trial registrationClinicalTrials.gov, identifier: NCT04568642.

Effects of closed loop ventilation on ventilator settings, patient outcomes and ICU staff workloads – a systematic review

“…The search identified a total of 801 studies; after removal of duplicates and screening for eligibility, 45 studies in adult 13–57 and six studies in paediatric patients 58–63 were considered for this analysis (Fig. 1 and eTable S1, http://links.lww.com/EJA/A926).…”

“…1 and eTable S1, http://links.lww.com/EJA/A926). Thirty-five studies had a parallel randomised design 13–19,21,23,25–31,33,34,36,38–40,43–57,62,63 ; 12 had a crossover randomised design 20,22,24,32,35,37,41,42,58–61 . Only five studies were multicentre investigations 23,33,36,38,39 .…”

“…Most studies were performed in critically ill patients with respiratory failure 15,16,18,22,24,26,27,29–31,33,35,36,39,41,46,47,54,62 ; twelve studies in patients after cardiac surgery 13,17,25,28,34,48–51,57 or general surgery, 20,23,43 four in difficult to wean patients, 19,32,38,40,56 four in COPD patients 14,21,44,45 and four in ARDS patients 37,42,53,55 . Nine studies tested SmartCare, 14,15,18,19,23,32,47,54,63 fourteen studies ASV, 13,17,21,42,43,45,46,48–53,55 eight studies INTELLiVENT–ASV, 22,24,25,27,28,30,34,35 eight studies NAVA, 20,36–41,62 six studies PAV+, 16,26,29,31,33,44 three studies Avea–CLiO 2 58–60 and one closed loop FiO 2 titrations during ASV 61 . Observation duration differed substantially between studies (eTable S1, http://links.lww.com/EJA/A926).…”

“…Smartcare, ASV and NAVA did not affect FiO 2 in critically ill patients, 47 cardiac surgery patients 51 and paediatric patients, 62 respectively. INTELLiVENT–ASV reduced FiO 2 in cardiac surgery patients 25,34 and in critically ill patients, 22,24,27,30 Avea–CLiO 2 and a closed loop FiO 2 controller available for use with ASV also increased time spent in preferred SpO 2 ranges in paediatric patients 58–61 …”

Closed-loop ventilation

“…In addition, it lowers the number of manual adjustments made to FiO2. Several systems have been shown to be effective in infants on noninvasive respiratory support or mechanical ventilation, and a recent study included also term-born infants [24,25 ▪ ]. In reality, use of these systems is still uncommon and there are large variations in practice [26].…”