The OPERA trial - comparison of early nasal high flow oxygen therapy with standard care for prevention of postoperative hypoxemia after abdominal surgery: study protocol for a multicenter randomized controlled trial.
Identifieur interne : 000202 ( PubMed/Checkpoint ); précédent : 000201; suivant : 000203The OPERA trial - comparison of early nasal high flow oxygen therapy with standard care for prevention of postoperative hypoxemia after abdominal surgery: study protocol for a multicenter randomized controlled trial.
Auteurs : Emmanuel Futier [France] ; Catherine Paugam-Burtz ; Jean-Michel Constantin ; Bruno Pereira ; Samir JaberSource :
- Trials ; 2013.
Descripteurs français
- Wicri :
- geographic : France.
English descriptors
- KwdEn :
- Abdomen (surgery), Airway Extubation, Anoxia (etiology), Anoxia (prevention & control), Clinical Protocols, France, Humans, Intubation, Intratracheal, Oxygen Inhalation Therapy (methods), Postoperative Complications (prevention & control), Research Design, Risk Factors, Time Factors, Treatment Outcome.
- MESH :
- geographic : France.
- etiology : Anoxia.
- methods : Oxygen Inhalation Therapy.
- prevention & control : Anoxia, Postoperative Complications.
- surgery : Abdomen.
- Airway Extubation, Clinical Protocols, Humans, Intubation, Intratracheal, Research Design, Risk Factors, Time Factors, Treatment Outcome.
Abstract
Respiratory support following postoperative extubation is of major importance to prevent hypoxemia and subsequent respiratory failure and reintubation. High-flow nasal cannula oxygen (HFNC) delivers a flow-dependent positive airway pressure and improves oxygenation by increasing end-expiratory lung volume. Whether application of HFNC may have therapeutic advantages over conventional oxygen therapy for respiratory support in the early postextubation surgical period remains to be established.
DOI: 10.1186/1745-6215-14-341
PubMed: 24138710
Affiliations:
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">The OPERA trial - comparison of early nasal high flow oxygen therapy with standard care for prevention of postoperative hypoxemia after abdominal surgery: study protocol for a multicenter randomized controlled trial.</title><author><name sortKey="Futier, Emmanuel" sort="Futier, Emmanuel" uniqKey="Futier E" first="Emmanuel" last="Futier">Emmanuel Futier</name><affiliation wicri:level="3"><nlm:affiliation>Department of Anesthesiology and Critical Care Medicine, Estaing Hospital, University Teaching Hospital of Clermont-Ferrand, 1, place Lucie Aubrac, Clermont-Ferrand Cedex 1, 63000, France. efutier@chu-clermontferrand.fr.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Anesthesiology and Critical Care Medicine, Estaing Hospital, University Teaching Hospital of Clermont-Ferrand, 1, place Lucie Aubrac, Clermont-Ferrand Cedex 1, 63000</wicri:regionArea><placeName><region type="region" nuts="2">Auvergne-Rhône-Alpes</region><region type="old region" nuts="2">Auvergne</region></placeName></affiliation></author><author><name sortKey="Paugam Burtz, Catherine" sort="Paugam Burtz, Catherine" uniqKey="Paugam Burtz C" first="Catherine" last="Paugam-Burtz">Catherine Paugam-Burtz</name></author><author><name sortKey="Constantin, Jean Michel" sort="Constantin, Jean Michel" uniqKey="Constantin J" first="Jean-Michel" last="Constantin">Jean-Michel Constantin</name></author><author><name sortKey="Pereira, Bruno" sort="Pereira, Bruno" uniqKey="Pereira B" first="Bruno" last="Pereira">Bruno Pereira</name></author><author><name sortKey="Jaber, Samir" sort="Jaber, Samir" uniqKey="Jaber S" first="Samir" last="Jaber">Samir Jaber</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2013">2013</date><idno type="doi">10.1186/1745-6215-14-341</idno><idno type="RBID">pubmed:24138710</idno><idno type="pmid">24138710</idno><idno type="wicri:Area/PubMed/Corpus">000203</idno><idno type="wicri:Area/PubMed/Curation">000203</idno><idno type="wicri:Area/PubMed/Checkpoint">000202</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">The OPERA trial - comparison of early nasal high flow oxygen therapy with standard care for prevention of postoperative hypoxemia after abdominal surgery: study protocol for a multicenter randomized controlled trial.</title><author><name sortKey="Futier, Emmanuel" sort="Futier, Emmanuel" uniqKey="Futier E" first="Emmanuel" last="Futier">Emmanuel Futier</name><affiliation wicri:level="3"><nlm:affiliation>Department of Anesthesiology and Critical Care Medicine, Estaing Hospital, University Teaching Hospital of Clermont-Ferrand, 1, place Lucie Aubrac, Clermont-Ferrand Cedex 1, 63000, France. efutier@chu-clermontferrand.fr.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Anesthesiology and Critical Care Medicine, Estaing Hospital, University Teaching Hospital of Clermont-Ferrand, 1, place Lucie Aubrac, Clermont-Ferrand Cedex 1, 63000</wicri:regionArea><placeName><region type="region" nuts="2">Auvergne-Rhône-Alpes</region><region type="old region" nuts="2">Auvergne</region></placeName></affiliation></author><author><name sortKey="Paugam Burtz, Catherine" sort="Paugam Burtz, Catherine" uniqKey="Paugam Burtz C" first="Catherine" last="Paugam-Burtz">Catherine Paugam-Burtz</name></author><author><name sortKey="Constantin, Jean Michel" sort="Constantin, Jean Michel" uniqKey="Constantin J" first="Jean-Michel" last="Constantin">Jean-Michel Constantin</name></author><author><name sortKey="Pereira, Bruno" sort="Pereira, Bruno" uniqKey="Pereira B" first="Bruno" last="Pereira">Bruno Pereira</name></author><author><name sortKey="Jaber, Samir" sort="Jaber, Samir" uniqKey="Jaber S" first="Samir" last="Jaber">Samir Jaber</name></author></analytic><series><title level="j">Trials</title><idno type="e-ISSN">1745-6215</idno><imprint><date when="2013" type="published">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Abdomen (surgery)</term><term>Airway Extubation</term><term>Anoxia (etiology)</term><term>Anoxia (prevention & control)</term><term>Clinical Protocols</term><term>France</term><term>Humans</term><term>Intubation, Intratracheal</term><term>Oxygen Inhalation Therapy (methods)</term><term>Postoperative Complications (prevention & control)</term><term>Research Design</term><term>Risk Factors</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>France</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Anoxia</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Oxygen Inhalation Therapy</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Anoxia</term><term>Postoperative Complications</term></keywords><keywords scheme="MESH" qualifier="surgery" xml:lang="en"><term>Abdomen</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Airway Extubation</term><term>Clinical Protocols</term><term>Humans</term><term>Intubation, Intratracheal</term><term>Research Design</term><term>Risk Factors</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>France</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Respiratory support following postoperative extubation is of major importance to prevent hypoxemia and subsequent respiratory failure and reintubation. High-flow nasal cannula oxygen (HFNC) delivers a flow-dependent positive airway pressure and improves oxygenation by increasing end-expiratory lung volume. Whether application of HFNC may have therapeutic advantages over conventional oxygen therapy for respiratory support in the early postextubation surgical period remains to be established.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">24138710</PMID><DateCreated><Year>2014</Year><Month>01</Month><Day>16</Day></DateCreated><DateCompleted><Year>2014</Year><Month>09</Month><Day>02</Day></DateCompleted><DateRevised><Year>2015</Year><Month>04</Month><Day>22</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1745-6215</ISSN><JournalIssue CitedMedium="Internet"><Volume>14</Volume><PubDate><Year>2013</Year></PubDate></JournalIssue><Title>Trials</Title><ISOAbbreviation>Trials</ISOAbbreviation></Journal><ArticleTitle>The OPERA trial - comparison of early nasal high flow oxygen therapy with standard care for prevention of postoperative hypoxemia after abdominal surgery: study protocol for a multicenter randomized controlled trial.</ArticleTitle><Pagination><MedlinePgn>341</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/1745-6215-14-341</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Respiratory support following postoperative extubation is of major importance to prevent hypoxemia and subsequent respiratory failure and reintubation. High-flow nasal cannula oxygen (HFNC) delivers a flow-dependent positive airway pressure and improves oxygenation by increasing end-expiratory lung volume. Whether application of HFNC may have therapeutic advantages over conventional oxygen therapy for respiratory support in the early postextubation surgical period remains to be established.</AbstractText><AbstractText Label="METHODS/DESIGN" NlmCategory="METHODS">The Optiflow for prevention of post-extubation hypoxemia after abdominal surgery (OPERA) trial is an investigator-initiated multicenter randomized controlled two-arm trial with assessor-blinded outcome assessment, randomizing 220 patients with intermediate to high risk of pulmonary complications after abdominal surgery to receive HFNC or conventional oxygen therapy following extubation, stratified by the presence of epidural analgesia and center. The primary outcome measure is the percentage of patients with postoperative hypoxemia one hour after tracheal extubation. Secondary outcome measures are postoperative pulmonary complications, need for noninvasive ventilation and intubation for respiratory failure.</AbstractText><AbstractText Label="DISCUSSION" NlmCategory="CONCLUSIONS">The OPERA trial is the first randomized controlled study powered to investigate whether early application of HFNC following extubation after abdominal surgery prevents against postoperative hypoxemia and pulmonary complications.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">ClinicalTrials.gov Identifier: NCT01887015.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Futier</LastName><ForeName>Emmanuel</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Department of Anesthesiology and Critical Care Medicine, Estaing Hospital, University Teaching Hospital of Clermont-Ferrand, 1, place Lucie Aubrac, Clermont-Ferrand Cedex 1, 63000, France. efutier@chu-clermontferrand.fr.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Paugam-Burtz</LastName><ForeName>Catherine</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Constantin</LastName><ForeName>Jean-Michel</ForeName><Initials>JM</Initials></Author><Author ValidYN="Y"><LastName>Pereira</LastName><ForeName>Bruno</ForeName><Initials>B</Initials></Author><Author ValidYN="Y"><LastName>Jaber</LastName><ForeName>Samir</ForeName><Initials>S</Initials></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT01887015</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2013</Year><Month>10</Month><Day>18</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Trials</MedlineTA><NlmUniqueID>101263253</NlmUniqueID><ISSNLinking>1745-6215</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Chest. 1996 Sep;110(3):744-50</RefSource><PMID Version="1">8797421</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Clin Anesth. 1994 May-Jun;6(3):212-6</RefSource><PMID Version="1">8060628</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>JAMA. 2005 Feb 2;293(5):589-95</RefSource><PMID Version="1">15687314</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Ann Surg. 2005 Sep;242(3):326-41; discussion 341-3</RefSource><PMID Version="1">16135919</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Chest. 2005 Oct;128(4):2688-95</RefSource><PMID Version="1">16236943</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>JAMA. 2006 Oct 18;296(15):1851-7</RefSource><PMID Version="1">17047215</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lancet. 2008 Jul 12;372(9633):139-44</RefSource><PMID Version="1">18582931</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Arch Surg. 2008 Oct;143(10):990-9; discussion 1000</RefSource><PMID Version="1">18936379</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Intensive Care Med. 2009 Jun;35(6):996-1003</RefSource><PMID Version="1">19294365</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Br J Anaesth. 2009 Dec;103(6):886-90</RefSource><PMID Version="1">19846404</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Anesthesiology. 2010 Feb;112(2):453-61</RefSource><PMID Version="1">20068454</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Anesthesiology. 2010 Dec;113(6):1338-50</RefSource><PMID Version="1">21045639</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Crit Care Med. 2011 Sep;39(9):2163-72</RefSource><PMID Version="1">21572323</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Br J Anaesth. 2011 Dec;107(6):998-1004</RefSource><PMID Version="1">21908497</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2013 Aug 1;369(5):428-37</RefSource><PMID Version="1">23902482</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Minerva Anestesiol. 2013 Dec;79(12):1344-55</RefSource><PMID Version="1">23857440</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Ann Surg. 2000 Aug;232(2):242-53</RefSource><PMID Version="1">10903604</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Br J Anaesth. 2002 Jun;88(6):771-8</RefSource><PMID Version="1">12173192</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Arch Surg. 2003 Jun;138(6):596-602; discussion 602-3</RefSource><PMID Version="1">12799329</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Acta Anaesthesiol Scand. 1992 Aug;36(6):546-53</RefSource><PMID Version="1">1514340</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Chest. 2004 Nov;126(5):1552-8</RefSource><PMID Version="1">15539726</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000005">Abdomen</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000601">surgery</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D060666">Airway Extubation</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000860">Anoxia</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000209">etiology</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000517">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D002985">Clinical Protocols</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" Type="Geographic" UI="D005602">France</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D007442">Intubation, Intratracheal</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D010102">Oxygen Inhalation Therapy</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000379">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D011183">Postoperative Complications</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000517">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="Y" UI="D012107">Research Design</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D012307">Risk Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D013997">Time Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D016896">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><OtherID Source="NLM">PMC3854478</OtherID></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2013</Year><Month>8</Month><Day>6</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2013</Year><Month>10</Month><Day>4</Day></PubMedPubDate><PubMedPubDate PubStatus="aheadofprint"><Year>2013</Year><Month>10</Month><Day>18</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2013</Year><Month>10</Month><Day>22</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2013</Year><Month>10</Month><Day>22</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2014</Year><Month>9</Month><Day>3</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pii">1745-6215-14-341</ArticleId><ArticleId IdType="doi">10.1186/1745-6215-14-341</ArticleId><ArticleId IdType="pubmed">24138710</ArticleId><ArticleId IdType="pmc">PMC3854478</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>France</li></country><region><li>Auvergne</li><li>Auvergne-Rhône-Alpes</li></region></list><tree><noCountry><name sortKey="Constantin, Jean Michel" sort="Constantin, Jean Michel" uniqKey="Constantin J" first="Jean-Michel" last="Constantin">Jean-Michel Constantin</name><name sortKey="Jaber, Samir" sort="Jaber, Samir" uniqKey="Jaber S" first="Samir" last="Jaber">Samir Jaber</name><name sortKey="Paugam Burtz, Catherine" sort="Paugam Burtz, Catherine" uniqKey="Paugam Burtz C" first="Catherine" last="Paugam-Burtz">Catherine Paugam-Burtz</name><name sortKey="Pereira, Bruno" sort="Pereira, Bruno" uniqKey="Pereira B" first="Bruno" last="Pereira">Bruno Pereira</name></noCountry><country name="France"><region name="Auvergne-Rhône-Alpes"><name sortKey="Futier, Emmanuel" sort="Futier, Emmanuel" uniqKey="Futier E" first="Emmanuel" last="Futier">Emmanuel Futier</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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