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

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 w...

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Main Authors: Ekin Soydan, Gokhan Ceylan, Sevgi Topal, Pinar Hepduman, Gulhan Atakul, Mustafa Colak, Ozlem Sandal, Ferhat Sari, Utku Karaarslan, Dominik Novotni, Marcus J. Schultz, Hasan Agin
Format: Article
Language:English
Published: Frontiers Media S.A. 2022-08-01
Series:Frontiers in Medicine
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Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2022.969218/full
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author Ekin Soydan
Gokhan Ceylan
Gokhan Ceylan
Sevgi Topal
Pinar Hepduman
Gulhan Atakul
Mustafa Colak
Ozlem Sandal
Ferhat Sari
Utku Karaarslan
Dominik Novotni
Marcus J. Schultz
Marcus J. Schultz
Hasan Agin
author_facet Ekin Soydan
Gokhan Ceylan
Gokhan Ceylan
Sevgi Topal
Pinar Hepduman
Gulhan Atakul
Mustafa Colak
Ozlem Sandal
Ferhat Sari
Utku Karaarslan
Dominik Novotni
Marcus J. Schultz
Marcus J. Schultz
Hasan Agin
author_sort Ekin Soydan
collection DOAJ
description 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.
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spelling doaj.art-89361778e965413c91ab0a623e487aae2022-12-22T02:16:18ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2022-08-01910.3389/fmed.2022.969218969218Automated closed–loop FiO2 titration increases the percentage of time spent in optimal zones of oxygen saturation in pediatric patients–A randomized crossover clinical trialEkin Soydan0Gokhan Ceylan1Gokhan Ceylan2Sevgi Topal3Pinar Hepduman4Gulhan Atakul5Mustafa Colak6Ozlem Sandal7Ferhat Sari8Utku Karaarslan9Dominik Novotni10Marcus J. Schultz11Marcus J. Schultz12Hasan Agin13Department of Pediatric Intensive Care Unit, Dr. Behcet Uz Children's Disease and Surgery Training and Research Hospital, Health Sciences University, Izmir, TurkeyDepartment of Pediatric Intensive Care Unit, Dr. Behcet Uz Children's Disease and Surgery Training and Research Hospital, Health Sciences University, Izmir, TurkeyDepartment of Medical Research, Hamilton Medical AG, Bonaduz, SwitzerlandDepartment of Pediatric Intensive Care Unit, Dr. Behcet Uz Children's Disease and Surgery Training and Research Hospital, Health Sciences University, Izmir, TurkeyDepartment of Pediatric Intensive Care Unit, Dr. Behcet Uz Children's Disease and Surgery Training and Research Hospital, Health Sciences University, Izmir, TurkeyDepartment of Pediatric Intensive Care Unit, Dr. Behcet Uz Children's Disease and Surgery Training and Research Hospital, Health Sciences University, Izmir, TurkeyDepartment of Pediatric Intensive Care Unit, Dr. Behcet Uz Children's Disease and Surgery Training and Research Hospital, Health Sciences University, Izmir, TurkeyDepartment of Pediatric Intensive Care Unit, Dr. Behcet Uz Children's Disease and Surgery Training and Research Hospital, Health Sciences University, Izmir, TurkeyDepartment of Pediatric Intensive Care Unit, Dr. Behcet Uz Children's Disease and Surgery Training and Research Hospital, Health Sciences University, Izmir, TurkeyDepartment of Pediatric Intensive Care Unit, Dr. Behcet Uz Children's Disease and Surgery Training and Research Hospital, Health Sciences University, Izmir, TurkeyDepartment of Medical Research, Hamilton Medical AG, Bonaduz, SwitzerlandDepartment of Medical Research, Hamilton Medical AG, Bonaduz, SwitzerlandDepartment of Intensive Care, Amsterdam UMC, Location “Academic Medical Center”, Amsterdam, NetherlandsDepartment of Pediatric Intensive Care Unit, Dr. Behcet Uz Children's Disease and Surgery Training and Research Hospital, Health Sciences University, Izmir, TurkeyIntroductionWe 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.https://www.frontiersin.org/articles/10.3389/fmed.2022.969218/fullintensive carepediatric intensive caremechanical ventilationAdaptive support ventilationASVclosed loop ventilation
spellingShingle Ekin Soydan
Gokhan Ceylan
Gokhan Ceylan
Sevgi Topal
Pinar Hepduman
Gulhan Atakul
Mustafa Colak
Ozlem Sandal
Ferhat Sari
Utku Karaarslan
Dominik Novotni
Marcus J. Schultz
Marcus J. Schultz
Hasan Agin
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
Frontiers in Medicine
intensive care
pediatric intensive care
mechanical ventilation
Adaptive support ventilation
ASV
closed loop ventilation
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic intensive care
pediatric intensive care
mechanical ventilation
Adaptive support ventilation
ASV
closed loop ventilation
url https://www.frontiersin.org/articles/10.3389/fmed.2022.969218/full
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