Effect of Conservative vs Conventional Oxygen Therapy on Mortality Among Patients in an Intensive Care Unit: The Oxygen-ICU Randomized Clinical Trial
IMPORTANCE: Despite suggestions of potential harm from unnecessary oxygen therapy, critically ill patients spend substantial periods in a hyperoxemic state. A strategy of controlled arterial oxygenation is thus rational but has not been validated in clinical practice. OBJECTIVE: To assess whether a...
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| Veröffentlicht in: | JAMA : the journal of the American Medical Association 2016-10, Vol.316 (15), p.1583-1589 |
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| creator | Girardis, Massimo Busani, Stefano Damiani, Elisa Donati, Abele Rinaldi, Laura Marudi, Andrea Morelli, Andrea Antonelli, Massimo Singer, Mervyn |
| description | IMPORTANCE: Despite suggestions of potential harm from unnecessary oxygen therapy, critically ill patients spend substantial periods in a hyperoxemic state. A strategy of controlled arterial oxygenation is thus rational but has not been validated in clinical practice. OBJECTIVE: To assess whether a conservative protocol for oxygen supplementation could improve outcomes in patients admitted to intensive care units (ICUs). DESIGN, SETTING, AND PATIENTS: Oxygen-ICU was a single-center, open-label, randomized clinical trial conducted from March 2010 to October 2012 that included all adults admitted with an expected length of stay of 72 hours or longer to the medical-surgical ICU of Modena University Hospital, Italy. The originally planned sample size was 660 patients, but the study was stopped early due to difficulties in enrollment after inclusion of 480 patients. INTERVENTIONS: Patients were randomly assigned to receive oxygen therapy to maintain Pao2 between 70 and 100 mm Hg or arterial oxyhemoglobin saturation (Spo2) between 94% and 98% (conservative group) or, according to standard ICU practice, to allow Pao2 values up to 150 mm Hg or Spo2 values between 97% and 100% (conventional control group). MAIN OUTCOMES AND MEASURES: The primary outcome was ICU mortality. Secondary outcomes included occurrence of new organ failure and infection 48 hours or more after ICU admission. RESULTS: A total of 434 patients (median age, 64 years; 188 [43.3%] women) received conventional (n = 218) or conservative (n = 216) oxygen therapy and were included in the modified intent-to-treat analysis. Daily time-weighted Pao2 averages during the ICU stay were significantly higher (P |
| doi_str_mv | 10.1001/jama.2016.11993 |
| format | Article |
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A strategy of controlled arterial oxygenation is thus rational but has not been validated in clinical practice. OBJECTIVE: To assess whether a conservative protocol for oxygen supplementation could improve outcomes in patients admitted to intensive care units (ICUs). DESIGN, SETTING, AND PATIENTS: Oxygen-ICU was a single-center, open-label, randomized clinical trial conducted from March 2010 to October 2012 that included all adults admitted with an expected length of stay of 72 hours or longer to the medical-surgical ICU of Modena University Hospital, Italy. The originally planned sample size was 660 patients, but the study was stopped early due to difficulties in enrollment after inclusion of 480 patients. INTERVENTIONS: Patients were randomly assigned to receive oxygen therapy to maintain Pao2 between 70 and 100 mm Hg or arterial oxyhemoglobin saturation (Spo2) between 94% and 98% (conservative group) or, according to standard ICU practice, to allow Pao2 values up to 150 mm Hg or Spo2 values between 97% and 100% (conventional control group). MAIN OUTCOMES AND MEASURES: The primary outcome was ICU mortality. Secondary outcomes included occurrence of new organ failure and infection 48 hours or more after ICU admission. RESULTS: A total of 434 patients (median age, 64 years; 188 [43.3%] women) received conventional (n = 218) or conservative (n = 216) oxygen therapy and were included in the modified intent-to-treat analysis. Daily time-weighted Pao2 averages during the ICU stay were significantly higher (P < .001) in the conventional group (median Pao2, 102 mm Hg [interquartile range, 88-116]) vs the conservative group (median Pao2, 87 mm Hg [interquartile range, 79-97]). Twenty-five patients in the conservative oxygen therapy group (11.6%) and 44 in the conventional oxygen therapy group (20.2%) died during their ICU stay (absolute risk reduction [ARR], 0.086 [95% CI, 0.017-0.150]; relative risk [RR], 0.57 [95% CI, 0.37-0.90]; P = .01). Occurrences were lower in the conservative oxygen therapy group for new shock episode (ARR, 0.068 [95% CI, 0.020-0.120]; RR, 0.35 [95% CI, 0.16-0.75]; P = .006) or liver failure (ARR, 0.046 [95% CI, 0.008-0.088]; RR, 0.29 [95% CI, 0.10-0.82]; P = .02) and new bloodstream infection (ARR, 0.05 [95% CI, 0.00-0.09]; RR, 0.50 [95% CI, 0.25-0.998; P = .049). CONCLUSIONS AND RELEVANCE: Among critically ill patients with an ICU length of stay of 72 hours or longer, a conservative protocol for oxygen therapy vs conventional therapy resulted in lower ICU mortality. These preliminary findings were based on unplanned early termination of the trial, and a larger multicenter trial is needed to evaluate the potential benefit of this approach. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01319643</description><identifier>ISSN: 0098-7484</identifier><identifier>EISSN: 1538-3598</identifier><identifier>DOI: 10.1001/jama.2016.11993</identifier><identifier>PMID: 27706466</identifier><identifier>CODEN: JAMAAP</identifier><language>eng</language><publisher>United States: American Medical Association</publisher><subject>Adult ; Aged ; Clinical outcomes ; Critical Illness ; Cross Infection - epidemiology ; Early Termination of Clinical Trials ; Female ; Hospital Mortality ; Humans ; Hyperoxia - prevention & control ; Intensive care ; Intensive Care Units - statistics & numerical data ; Length of Stay ; Liver Failure - epidemiology ; Male ; Middle Aged ; Oxygen - blood ; Oxygen Inhalation Therapy - methods ; Oxygen therapy ; Partial Pressure ; Shock - epidemiology</subject><ispartof>JAMA : the journal of the American Medical Association, 2016-10, Vol.316 (15), p.1583-1589</ispartof><rights>Copyright American Medical Association Oct 18, 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jamanetwork.com/journals/jama/articlepdf/10.1001/jama.2016.11993$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2016.11993$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,314,777,781,3327,27905,27906,76238,76241</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27706466$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Girardis, Massimo</creatorcontrib><creatorcontrib>Busani, Stefano</creatorcontrib><creatorcontrib>Damiani, Elisa</creatorcontrib><creatorcontrib>Donati, Abele</creatorcontrib><creatorcontrib>Rinaldi, Laura</creatorcontrib><creatorcontrib>Marudi, Andrea</creatorcontrib><creatorcontrib>Morelli, Andrea</creatorcontrib><creatorcontrib>Antonelli, Massimo</creatorcontrib><creatorcontrib>Singer, Mervyn</creatorcontrib><title>Effect of Conservative vs Conventional Oxygen Therapy on Mortality Among Patients in an Intensive Care Unit: The Oxygen-ICU Randomized Clinical Trial</title><title>JAMA : the journal of the American Medical Association</title><addtitle>JAMA</addtitle><description>IMPORTANCE: Despite suggestions of potential harm from unnecessary oxygen therapy, critically ill patients spend substantial periods in a hyperoxemic state. A strategy of controlled arterial oxygenation is thus rational but has not been validated in clinical practice. OBJECTIVE: To assess whether a conservative protocol for oxygen supplementation could improve outcomes in patients admitted to intensive care units (ICUs). DESIGN, SETTING, AND PATIENTS: Oxygen-ICU was a single-center, open-label, randomized clinical trial conducted from March 2010 to October 2012 that included all adults admitted with an expected length of stay of 72 hours or longer to the medical-surgical ICU of Modena University Hospital, Italy. The originally planned sample size was 660 patients, but the study was stopped early due to difficulties in enrollment after inclusion of 480 patients. INTERVENTIONS: Patients were randomly assigned to receive oxygen therapy to maintain Pao2 between 70 and 100 mm Hg or arterial oxyhemoglobin saturation (Spo2) between 94% and 98% (conservative group) or, according to standard ICU practice, to allow Pao2 values up to 150 mm Hg or Spo2 values between 97% and 100% (conventional control group). MAIN OUTCOMES AND MEASURES: The primary outcome was ICU mortality. Secondary outcomes included occurrence of new organ failure and infection 48 hours or more after ICU admission. RESULTS: A total of 434 patients (median age, 64 years; 188 [43.3%] women) received conventional (n = 218) or conservative (n = 216) oxygen therapy and were included in the modified intent-to-treat analysis. Daily time-weighted Pao2 averages during the ICU stay were significantly higher (P < .001) in the conventional group (median Pao2, 102 mm Hg [interquartile range, 88-116]) vs the conservative group (median Pao2, 87 mm Hg [interquartile range, 79-97]). Twenty-five patients in the conservative oxygen therapy group (11.6%) and 44 in the conventional oxygen therapy group (20.2%) died during their ICU stay (absolute risk reduction [ARR], 0.086 [95% CI, 0.017-0.150]; relative risk [RR], 0.57 [95% CI, 0.37-0.90]; P = .01). Occurrences were lower in the conservative oxygen therapy group for new shock episode (ARR, 0.068 [95% CI, 0.020-0.120]; RR, 0.35 [95% CI, 0.16-0.75]; P = .006) or liver failure (ARR, 0.046 [95% CI, 0.008-0.088]; RR, 0.29 [95% CI, 0.10-0.82]; P = .02) and new bloodstream infection (ARR, 0.05 [95% CI, 0.00-0.09]; RR, 0.50 [95% CI, 0.25-0.998; P = .049). CONCLUSIONS AND RELEVANCE: Among critically ill patients with an ICU length of stay of 72 hours or longer, a conservative protocol for oxygen therapy vs conventional therapy resulted in lower ICU mortality. These preliminary findings were based on unplanned early termination of the trial, and a larger multicenter trial is needed to evaluate the potential benefit of this approach. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01319643</description><subject>Adult</subject><subject>Aged</subject><subject>Clinical outcomes</subject><subject>Critical Illness</subject><subject>Cross Infection - epidemiology</subject><subject>Early Termination of Clinical Trials</subject><subject>Female</subject><subject>Hospital Mortality</subject><subject>Humans</subject><subject>Hyperoxia - prevention & control</subject><subject>Intensive care</subject><subject>Intensive Care Units - statistics & numerical data</subject><subject>Length of Stay</subject><subject>Liver Failure - epidemiology</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Oxygen - blood</subject><subject>Oxygen Inhalation Therapy - methods</subject><subject>Oxygen therapy</subject><subject>Partial Pressure</subject><subject>Shock - epidemiology</subject><issn>0098-7484</issn><issn>1538-3598</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkUFv2yAYhlHVas26nSvtUCH1sotTMDaG3iqrWyN16jQlZ-uLDR2RDSmQqOn_2P8dbtIeygGEeN4HwYvQOSVTSgi9WsEA05xQPqVUSnaEJrRkImOlFMdoQogUWVWI4hR9DmFF0qCs-oRO86oivOB8gv7daq3aiJ3GtbNB-S1Es1V4G8b9VtlonIUePzzvHpXF87_Kw3qHncW_nI_Qm7jDN4Ozj_h3CiY8YGMxWDyzUdkwqmrwCi-siddj_GDKZvUC_wHbucG8qA7XvbGmTRfNvYH-CzrR0Af19bCeocWP23l9l90__JzVN_cZ5FLENAvWApedloLRgnBQQudLyAlZ6qLj6bE5FRVnQoDMeUu10CWtuJYtVAUIdoa-771r7542KsRmMKFVfQ9WuU1oqGAl44IWRUIvP6Art_Hpa14pljMi5Si82lOtdyF4pZu1NwP4XUNJMzbWjI01Y2PNa2MpcXHwbpaD6t75t4oS8G0PjMH305KXjHD2H5FEmlg</recordid><startdate>20161018</startdate><enddate>20161018</enddate><creator>Girardis, Massimo</creator><creator>Busani, Stefano</creator><creator>Damiani, Elisa</creator><creator>Donati, Abele</creator><creator>Rinaldi, Laura</creator><creator>Marudi, Andrea</creator><creator>Morelli, Andrea</creator><creator>Antonelli, Massimo</creator><creator>Singer, Mervyn</creator><general>American Medical Association</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7QP</scope><scope>7TK</scope><scope>7TS</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope></search><sort><creationdate>20161018</creationdate><title>Effect of Conservative vs Conventional Oxygen Therapy on Mortality Among Patients in an Intensive Care Unit: The Oxygen-ICU Randomized Clinical Trial</title><author>Girardis, Massimo ; 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A strategy of controlled arterial oxygenation is thus rational but has not been validated in clinical practice. OBJECTIVE: To assess whether a conservative protocol for oxygen supplementation could improve outcomes in patients admitted to intensive care units (ICUs). DESIGN, SETTING, AND PATIENTS: Oxygen-ICU was a single-center, open-label, randomized clinical trial conducted from March 2010 to October 2012 that included all adults admitted with an expected length of stay of 72 hours or longer to the medical-surgical ICU of Modena University Hospital, Italy. The originally planned sample size was 660 patients, but the study was stopped early due to difficulties in enrollment after inclusion of 480 patients. INTERVENTIONS: Patients were randomly assigned to receive oxygen therapy to maintain Pao2 between 70 and 100 mm Hg or arterial oxyhemoglobin saturation (Spo2) between 94% and 98% (conservative group) or, according to standard ICU practice, to allow Pao2 values up to 150 mm Hg or Spo2 values between 97% and 100% (conventional control group). MAIN OUTCOMES AND MEASURES: The primary outcome was ICU mortality. Secondary outcomes included occurrence of new organ failure and infection 48 hours or more after ICU admission. RESULTS: A total of 434 patients (median age, 64 years; 188 [43.3%] women) received conventional (n = 218) or conservative (n = 216) oxygen therapy and were included in the modified intent-to-treat analysis. Daily time-weighted Pao2 averages during the ICU stay were significantly higher (P < .001) in the conventional group (median Pao2, 102 mm Hg [interquartile range, 88-116]) vs the conservative group (median Pao2, 87 mm Hg [interquartile range, 79-97]). Twenty-five patients in the conservative oxygen therapy group (11.6%) and 44 in the conventional oxygen therapy group (20.2%) died during their ICU stay (absolute risk reduction [ARR], 0.086 [95% CI, 0.017-0.150]; relative risk [RR], 0.57 [95% CI, 0.37-0.90]; P = .01). Occurrences were lower in the conservative oxygen therapy group for new shock episode (ARR, 0.068 [95% CI, 0.020-0.120]; RR, 0.35 [95% CI, 0.16-0.75]; P = .006) or liver failure (ARR, 0.046 [95% CI, 0.008-0.088]; RR, 0.29 [95% CI, 0.10-0.82]; P = .02) and new bloodstream infection (ARR, 0.05 [95% CI, 0.00-0.09]; RR, 0.50 [95% CI, 0.25-0.998; P = .049). CONCLUSIONS AND RELEVANCE: Among critically ill patients with an ICU length of stay of 72 hours or longer, a conservative protocol for oxygen therapy vs conventional therapy resulted in lower ICU mortality. These preliminary findings were based on unplanned early termination of the trial, and a larger multicenter trial is needed to evaluate the potential benefit of this approach. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01319643</abstract><cop>United States</cop><pub>American Medical Association</pub><pmid>27706466</pmid><doi>10.1001/jama.2016.11993</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Aged Clinical outcomes Critical Illness Cross Infection - epidemiology Early Termination of Clinical Trials Female Hospital Mortality Humans Hyperoxia - prevention & control Intensive care Intensive Care Units - statistics & numerical data Length of Stay Liver Failure - epidemiology Male Middle Aged Oxygen - blood Oxygen Inhalation Therapy - methods Oxygen therapy Partial Pressure Shock - epidemiology |
| title | Effect of Conservative vs Conventional Oxygen Therapy on Mortality Among Patients in an Intensive Care Unit: The Oxygen-ICU Randomized Clinical Trial |
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