Conservative versus Liberal Oxygenation Targets in Intensive Care Unit Patients (ICONIC) : A Randomized Clinical Trial
Rationale: Supplemental oxygen is widely administered to ICU patients, but appropriate oxygenation targets remain unclear. Objectives: This study aimed to determine whether a low-oxygenation strategy would lower 28-day mortality compared with a high-oxygenation strategy. Methods: This randomized multicenter trial included mechanically ventilated ICU patients with an expected ventilation duration of at least 24 hours. Patients were randomized 1:1 to a low-oxygenation (PaO2, 55-80 mm Hg; or oxygen saturation as measured by pulse oximetry, 91-94%) or high-oxygenation (PaO2, 110-150 mm Hg; or oxygen saturation as measured by pulse oximetry, 96-100%) target until ICU discharge or 28 days after randomization, whichever came first. The primary outcome was 28-day mortality. The study was stopped prematurely because of the COVID-19 pandemic when 664 of the planned 1,512 patients were included. Measurements and Main Results: Between November 2018 and November 2021, a total of 664 patients were included in the trial: 335 in the low-oxygenation group and 329 in the high-oxygenation group. The median achieved PaO2 was 75 mm Hg (interquartile range, 70-84) and 115 mm Hg (interquartile range, 100-129) in the low- and high-oxygenation groups, respectively. At Day 28, 129 (38.5%) and 114 (34.7%) patients had died in the low- and high-oxygenation groups, respectively (risk ratio, 1.11; 95% confidence interval, 0.9-1.4; P = 0.30). At least one serious adverse event was reported in 12 (3.6%) and 17 (5.2%) patients in the low- and high-oxygenation groups, respectively. Conclusions: Among mechanically ventilated ICU patients with an expected mechanical ventilation duration of at least 24 hours, using a low-oxygenation strategy did not result in a reduction of 28-day mortality compared with a high-oxygenation strategy. Clinical trial registered with the National Trial Register and the International Clinical Trials Registry Platform (NTR7376).
| Errataetall: |
CommentIn: Am J Respir Crit Care Med. 2023 Oct 1;208(7):746-748. - PMID 37610828 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:208 |
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| Enthalten in: |
American journal of respiratory and critical care medicine - 208(2023), 7 vom: 01. Okt., Seite 770-779 |
| Sprache: |
Englisch |
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| Links: |
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| Themen: |
Hyperoxia |
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| Anmerkungen: |
Date Completed 09.11.2023 Date Revised 29.11.2023 published: Print NTR: NTR7376 CommentIn: Am J Respir Crit Care Med. 2023 Oct 1;208(7):746-748. - PMID 37610828 Citation Status MEDLINE |
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| doi: |
10.1164/rccm.202303-0560OC |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM360522009 |
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| 041 | |a eng | ||
| 100 | 1 | |a van der Wal, L Imeen |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Conservative versus Liberal Oxygenation Targets in Intensive Care Unit Patients (ICONIC) |b A Randomized Clinical Trial |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
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| 500 | |a Date Completed 09.11.2023 | ||
| 500 | |a Date Revised 29.11.2023 | ||
| 500 | |a published: Print | ||
| 500 | |a NTR: NTR7376 | ||
| 500 | |a CommentIn: Am J Respir Crit Care Med. 2023 Oct 1;208(7):746-748. - PMID 37610828 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Rationale: Supplemental oxygen is widely administered to ICU patients, but appropriate oxygenation targets remain unclear. Objectives: This study aimed to determine whether a low-oxygenation strategy would lower 28-day mortality compared with a high-oxygenation strategy. Methods: This randomized multicenter trial included mechanically ventilated ICU patients with an expected ventilation duration of at least 24 hours. Patients were randomized 1:1 to a low-oxygenation (PaO2, 55-80 mm Hg; or oxygen saturation as measured by pulse oximetry, 91-94%) or high-oxygenation (PaO2, 110-150 mm Hg; or oxygen saturation as measured by pulse oximetry, 96-100%) target until ICU discharge or 28 days after randomization, whichever came first. The primary outcome was 28-day mortality. The study was stopped prematurely because of the COVID-19 pandemic when 664 of the planned 1,512 patients were included. Measurements and Main Results: Between November 2018 and November 2021, a total of 664 patients were included in the trial: 335 in the low-oxygenation group and 329 in the high-oxygenation group. The median achieved PaO2 was 75 mm Hg (interquartile range, 70-84) and 115 mm Hg (interquartile range, 100-129) in the low- and high-oxygenation groups, respectively. At Day 28, 129 (38.5%) and 114 (34.7%) patients had died in the low- and high-oxygenation groups, respectively (risk ratio, 1.11; 95% confidence interval, 0.9-1.4; P = 0.30). At least one serious adverse event was reported in 12 (3.6%) and 17 (5.2%) patients in the low- and high-oxygenation groups, respectively. Conclusions: Among mechanically ventilated ICU patients with an expected mechanical ventilation duration of at least 24 hours, using a low-oxygenation strategy did not result in a reduction of 28-day mortality compared with a high-oxygenation strategy. Clinical trial registered with the National Trial Register and the International Clinical Trials Registry Platform (NTR7376) | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a hyperoxia | |
| 650 | 4 | |a hypoxia | |
| 650 | 4 | |a intensive care medicine | |
| 650 | 4 | |a mechanical ventilation | |
| 650 | 4 | |a oxygen | |
| 700 | 1 | |a Grim, Chloe C A |e verfasserin |4 aut | |
| 700 | 1 | |a Del Prado, Michael R |e verfasserin |4 aut | |
| 700 | 1 | |a van Westerloo, David J |e verfasserin |4 aut | |
| 700 | 1 | |a Boerma, E Christiaan |e verfasserin |4 aut | |
| 700 | 1 | |a Rijnhart-de Jong, Hilda G |e verfasserin |4 aut | |
| 700 | 1 | |a Reidinga, Auke C |e verfasserin |4 aut | |
| 700 | 1 | |a Loef, Bert G |e verfasserin |4 aut | |
| 700 | 1 | |a van der Heiden, Pim L J |e verfasserin |4 aut | |
| 700 | 1 | |a Sigtermans, Marnix J |e verfasserin |4 aut | |
| 700 | 1 | |a Paulus, Frederique |e verfasserin |4 aut | |
| 700 | 1 | |a Cornet, Alexander D |e verfasserin |4 aut | |
| 700 | 1 | |a Loconte, Maurizio |e verfasserin |4 aut | |
| 700 | 1 | |a Schoonderbeek, F Jeannette |e verfasserin |4 aut | |
| 700 | 1 | |a de Keizer, Nicolette F |e verfasserin |4 aut | |
| 700 | 1 | |a Bakhshi-Raiez, Ferishta |e verfasserin |4 aut | |
| 700 | 1 | |a Le Cessie, Saskia |e verfasserin |4 aut | |
| 700 | 1 | |a Serpa Neto, Ary |e verfasserin |4 aut | |
| 700 | 1 | |a Pelosi, Paolo |e verfasserin |4 aut | |
| 700 | 1 | |a Schultz, Marcus J |e verfasserin |4 aut | |
| 700 | 1 | |a Helmerhorst, Hendrik J F |e verfasserin |4 aut | |
| 700 | 1 | |a de Jonge, Evert |e verfasserin |4 aut | |
| 700 | 0 | |a ICONIC investigators |e verfasserin |4 aut | |
| 700 | 1 | |a Wigbers, Jeanette |e investigator |4 oth | |
| 700 | 1 | |a Termorshuizen, Fabian |e investigator |4 oth | |
| 700 | 1 | |a Klop, Cintha |e investigator |4 oth | |
| 700 | 1 | |a Dawson, Lilian |e investigator |4 oth | |
| 700 | 1 | |a Schriel-van den Berg, Yvonne |e investigator |4 oth | |
| 700 | 1 | |a de Vreede, Els |e investigator |4 oth | |
| 700 | 1 | |a Qualm, Jolanda |e investigator |4 oth | |
| 700 | 1 | |a Koopmans, Matty |e investigator |4 oth | |
| 700 | 1 | |a Krol, Tim |e investigator |4 oth | |
| 700 | 1 | |a Rinket, Martin |e investigator |4 oth | |
| 700 | 1 | |a Vermeijden, Wytze |e investigator |4 oth | |
| 700 | 1 | |a Beishuizen, Albertus |e investigator |4 oth | |
| 700 | 1 | |a van Holten, Jantine |e investigator |4 oth | |
| 700 | 1 | |a Tsonas, Anissa |e investigator |4 oth | |
| 700 | 1 | |a Botta, Michela |e investigator |4 oth | |
| 700 | 1 | |a Winters, Tineke |e investigator |4 oth | |
| 700 | 1 | |a Horn, Janneke |e investigator |4 oth | |
| 700 | 1 | |a Battaglini, Denise |e investigator |4 oth | |
| 700 | 1 | |a Ball, Lorenzo |e investigator |4 oth | |
| 700 | 1 | |a Brunetti, Iole |e investigator |4 oth | |
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