Impact of tracheal cuff shape on microaspiration of gastric contents in intubated critically ill patients: study protocol for a randomized controlled trial
Ventilator-associated pneumonia (VAP) is the most common infection in intubated critically ill patients. Microaspiration of the contaminated gastric and oropharyngeal secretions is the main mechanism involved in the pathophysiology of VAP. Tracheal cuff plays an important role in stopping the progre...
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| Veröffentlicht in: | Current controlled trials in cardiovascular medicine 2015-09, Vol.16 (1), p.429-429, Article 429 |
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| creator | Jaillette, Emmanuelle Brunin, Guillaume Girault, Christophe Zerimech, Farid Chiche, Arnaud Broucqsault-Dedrie, Céline Fayolle, Cyril Minacori, Franck Alves, Isabelle Barrailler, Stephanie Robriquet, Laurent Tamion, Fabienne Delaporte, Emmanuel Thellier, Damien Delcourte, Claire Duhamel, Alain Nseir, Saad |
| description | Ventilator-associated pneumonia (VAP) is the most common infection in intubated critically ill patients. Microaspiration of the contaminated gastric and oropharyngeal secretions is the main mechanism involved in the pathophysiology of VAP. Tracheal cuff plays an important role in stopping the progression of contaminated secretions into the lower respiratory tract. Previous in vitro studies suggested that conical cuff shape might be helpful in improving tracheal sealing. However, clinical studies found conflicting results. The aim of this study is to determine the impact of conical tracheal cuff shape on the microaspiration of gastric contents in critically ill patients.
This prospective cluster randomized controlled crossover open-label trial is currently being conducted in ten French intensive care units (ICUs). Patients are allocated to intubation with a polyvinyl chloride (PVC) standard (barrel)-shaped or a PVC conical-shaped tracheal tube. The primary objective is to determine the impact of the conical shaped tracheal cuff on abundant microaspiration of gastric contents. Secondary outcomes include the incidence of microaspiration of oropharyngeal secretions, tracheobronchial colonization, VAP and ventilator-associated events. Abundant microaspiration is defined as the presence of pepsin at significant level (>200 ng/ml) in at least 30 % of the tracheal aspirates. Pepsin and amylase are quantitatively measured in all tracheal aspirates during the 48 h following inclusion. Quantitative tracheal aspirate culture is performed at inclusion and twice weekly. We plan to recruit 312 patients in the participating ICUs.
BEST Cuff is the first randomized controlled study evaluating the impact of PVC tracheal-cuff shape on gastric microaspirations in patients receiving invasive mechanical ventilation. Enrollment began in June 2014 and is expected to end in October 2015.
ClinicalTrials.gov Identifier: NCT01948635 (registered 31 August 2013). |
| doi_str_mv | 10.1186/s13063-015-0955-z |
| format | Article |
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This prospective cluster randomized controlled crossover open-label trial is currently being conducted in ten French intensive care units (ICUs). Patients are allocated to intubation with a polyvinyl chloride (PVC) standard (barrel)-shaped or a PVC conical-shaped tracheal tube. The primary objective is to determine the impact of the conical shaped tracheal cuff on abundant microaspiration of gastric contents. Secondary outcomes include the incidence of microaspiration of oropharyngeal secretions, tracheobronchial colonization, VAP and ventilator-associated events. Abundant microaspiration is defined as the presence of pepsin at significant level (>200 ng/ml) in at least 30 % of the tracheal aspirates. Pepsin and amylase are quantitatively measured in all tracheal aspirates during the 48 h following inclusion. Quantitative tracheal aspirate culture is performed at inclusion and twice weekly. We plan to recruit 312 patients in the participating ICUs.
BEST Cuff is the first randomized controlled study evaluating the impact of PVC tracheal-cuff shape on gastric microaspirations in patients receiving invasive mechanical ventilation. Enrollment began in June 2014 and is expected to end in October 2015.
ClinicalTrials.gov Identifier: NCT01948635 (registered 31 August 2013).</description><identifier>ISSN: 1745-6215</identifier><identifier>EISSN: 1745-6215</identifier><identifier>DOI: 10.1186/s13063-015-0955-z</identifier><identifier>PMID: 26407612</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Amylases - metabolism ; Antibiotics ; Bacterial pneumonia ; Bacteriological Techniques ; Biomarkers - metabolism ; Bronchoscopy ; Care and treatment ; Chest Tubes - adverse effects ; Clinical Enzyme Tests ; Clinical Protocols ; Clinical trials ; Complications and side effects ; Consent ; Critical Illness ; Cross-Over Studies ; Development and progression ; Enteral nutrition ; Equipment Design ; France ; Gastrointestinal Contents - enzymology ; Gastrointestinal Contents - microbiology ; Health aspects ; Humans ; Intensive care ; Intensive Care Units ; Intervention ; Intubation ; Intubation, Intratracheal - adverse effects ; Intubation, Intratracheal - instrumentation ; Medical research ; Medicine, Experimental ; Microorganisms ; Ostomy ; Pathogenesis ; Patient outcomes ; Patients ; Pepsin A - metabolism ; Pneumonia ; Pneumonia, Ventilator-Associated - diagnosis ; Pneumonia, Ventilator-Associated - etiology ; Pneumonia, Ventilator-Associated - microbiology ; Pneumonia, Ventilator-Associated - prevention & control ; Polyvinyl Chloride ; Prevention ; Prospective Studies ; Research Design ; Respiration, Artificial - adverse effects ; Respiration, Artificial - instrumentation ; Respiratory Aspiration of Gastric Contents - diagnosis ; Respiratory Aspiration of Gastric Contents - etiology ; Respiratory Aspiration of Gastric Contents - microbiology ; Respiratory Aspiration of Gastric Contents - prevention & control ; Risk Factors ; Study Protocol ; Time Factors ; Treatment Outcome ; Ventilators</subject><ispartof>Current controlled trials in cardiovascular medicine, 2015-09, Vol.16 (1), p.429-429, Article 429</ispartof><rights>COPYRIGHT 2015 BioMed Central Ltd.</rights><rights>Jaillette et al. 2015. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Jaillette et al. 2015</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c494t-990419c8245569651a75064875f7d5da59d3219c352b40016d4af37affe8bdba3</citedby><cites>FETCH-LOGICAL-c494t-990419c8245569651a75064875f7d5da59d3219c352b40016d4af37affe8bdba3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4583738/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4583738/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,315,728,781,785,865,886,27928,27929,53795,53797</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26407612$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Jaillette, Emmanuelle</creatorcontrib><creatorcontrib>Brunin, Guillaume</creatorcontrib><creatorcontrib>Girault, Christophe</creatorcontrib><creatorcontrib>Zerimech, Farid</creatorcontrib><creatorcontrib>Chiche, Arnaud</creatorcontrib><creatorcontrib>Broucqsault-Dedrie, Céline</creatorcontrib><creatorcontrib>Fayolle, Cyril</creatorcontrib><creatorcontrib>Minacori, Franck</creatorcontrib><creatorcontrib>Alves, Isabelle</creatorcontrib><creatorcontrib>Barrailler, Stephanie</creatorcontrib><creatorcontrib>Robriquet, Laurent</creatorcontrib><creatorcontrib>Tamion, Fabienne</creatorcontrib><creatorcontrib>Delaporte, Emmanuel</creatorcontrib><creatorcontrib>Thellier, Damien</creatorcontrib><creatorcontrib>Delcourte, Claire</creatorcontrib><creatorcontrib>Duhamel, Alain</creatorcontrib><creatorcontrib>Nseir, Saad</creatorcontrib><title>Impact of tracheal cuff shape on microaspiration of gastric contents in intubated critically ill patients: study protocol for a randomized controlled trial</title><title>Current controlled trials in cardiovascular medicine</title><addtitle>Trials</addtitle><description>Ventilator-associated pneumonia (VAP) is the most common infection in intubated critically ill patients. Microaspiration of the contaminated gastric and oropharyngeal secretions is the main mechanism involved in the pathophysiology of VAP. Tracheal cuff plays an important role in stopping the progression of contaminated secretions into the lower respiratory tract. Previous in vitro studies suggested that conical cuff shape might be helpful in improving tracheal sealing. However, clinical studies found conflicting results. The aim of this study is to determine the impact of conical tracheal cuff shape on the microaspiration of gastric contents in critically ill patients.
This prospective cluster randomized controlled crossover open-label trial is currently being conducted in ten French intensive care units (ICUs). Patients are allocated to intubation with a polyvinyl chloride (PVC) standard (barrel)-shaped or a PVC conical-shaped tracheal tube. The primary objective is to determine the impact of the conical shaped tracheal cuff on abundant microaspiration of gastric contents. Secondary outcomes include the incidence of microaspiration of oropharyngeal secretions, tracheobronchial colonization, VAP and ventilator-associated events. Abundant microaspiration is defined as the presence of pepsin at significant level (>200 ng/ml) in at least 30 % of the tracheal aspirates. Pepsin and amylase are quantitatively measured in all tracheal aspirates during the 48 h following inclusion. Quantitative tracheal aspirate culture is performed at inclusion and twice weekly. We plan to recruit 312 patients in the participating ICUs.
BEST Cuff is the first randomized controlled study evaluating the impact of PVC tracheal-cuff shape on gastric microaspirations in patients receiving invasive mechanical ventilation. Enrollment began in June 2014 and is expected to end in October 2015.
ClinicalTrials.gov Identifier: NCT01948635 (registered 31 August 2013).</description><subject>Amylases - metabolism</subject><subject>Antibiotics</subject><subject>Bacterial pneumonia</subject><subject>Bacteriological Techniques</subject><subject>Biomarkers - metabolism</subject><subject>Bronchoscopy</subject><subject>Care and treatment</subject><subject>Chest Tubes - adverse effects</subject><subject>Clinical Enzyme Tests</subject><subject>Clinical Protocols</subject><subject>Clinical trials</subject><subject>Complications and side effects</subject><subject>Consent</subject><subject>Critical Illness</subject><subject>Cross-Over Studies</subject><subject>Development and progression</subject><subject>Enteral nutrition</subject><subject>Equipment Design</subject><subject>France</subject><subject>Gastrointestinal Contents - enzymology</subject><subject>Gastrointestinal Contents - microbiology</subject><subject>Health aspects</subject><subject>Humans</subject><subject>Intensive care</subject><subject>Intensive Care Units</subject><subject>Intervention</subject><subject>Intubation</subject><subject>Intubation, Intratracheal - adverse effects</subject><subject>Intubation, Intratracheal - instrumentation</subject><subject>Medical research</subject><subject>Medicine, Experimental</subject><subject>Microorganisms</subject><subject>Ostomy</subject><subject>Pathogenesis</subject><subject>Patient outcomes</subject><subject>Patients</subject><subject>Pepsin A - metabolism</subject><subject>Pneumonia</subject><subject>Pneumonia, Ventilator-Associated - diagnosis</subject><subject>Pneumonia, Ventilator-Associated - etiology</subject><subject>Pneumonia, Ventilator-Associated - microbiology</subject><subject>Pneumonia, Ventilator-Associated - prevention & control</subject><subject>Polyvinyl Chloride</subject><subject>Prevention</subject><subject>Prospective Studies</subject><subject>Research Design</subject><subject>Respiration, Artificial - adverse effects</subject><subject>Respiration, Artificial - instrumentation</subject><subject>Respiratory Aspiration of Gastric Contents - diagnosis</subject><subject>Respiratory Aspiration of Gastric Contents - etiology</subject><subject>Respiratory Aspiration of Gastric Contents - microbiology</subject><subject>Respiratory Aspiration of Gastric Contents - prevention & control</subject><subject>Risk Factors</subject><subject>Study Protocol</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Ventilators</subject><issn>1745-6215</issn><issn>1745-6215</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNptUs1qFTEYHUSxtfoAbiTgxs3UZPI3cSGU4k-h4EbX4buZ5N6UzGRMMoV7X8WXNcOttRVJIF-Scw75ck7TvCb4nJBevM-EYkFbTHiLFeft4UlzSiTjregIf_qgPmle5HyDMaOKsufNSScYloJ0p82vq3EGU1B0qCQwOwsBmcU5lHcwWxQnNHqTIuTZJyi-7ityC7kkb5CJU7FTychPdZZlA8UOyCRfvIEQ9siHgOZKW0EfUC7LsEdziiWaGJCLCQFKMA1x9IeVWOVSDKGWVR7Cy-aZg5Dtq7v1rPnx-dP3y6_t9bcvV5cX161hipVWKcyIMn3HOBdKcAKSY8F6yZ0c-ABcDbSrAMq7DcOYiIGBoxKcs_1m2AA9az4ededlM9rB1NcmCHpOfoS01xG8fnwz-Z3exlvNeE8l7avAuzuBFH8uNhc9-mxsCDDZuGRNJOmxZKpnFfr2H-hNXNJU29OdVLzrO0zoX9QWgtV-cnE1ZxXVF5wRrqToVq3z_6DqGGw1LU7W-Xr-iECOhOpozsm6-x4J1mui9DFRuiZKr4nSh8p58_Bz7hl_IkR_AwMvyVw</recordid><startdate>20150925</startdate><enddate>20150925</enddate><creator>Jaillette, Emmanuelle</creator><creator>Brunin, Guillaume</creator><creator>Girault, Christophe</creator><creator>Zerimech, Farid</creator><creator>Chiche, Arnaud</creator><creator>Broucqsault-Dedrie, Céline</creator><creator>Fayolle, Cyril</creator><creator>Minacori, Franck</creator><creator>Alves, Isabelle</creator><creator>Barrailler, Stephanie</creator><creator>Robriquet, Laurent</creator><creator>Tamion, Fabienne</creator><creator>Delaporte, Emmanuel</creator><creator>Thellier, Damien</creator><creator>Delcourte, Claire</creator><creator>Duhamel, Alain</creator><creator>Nseir, Saad</creator><general>BioMed Central Ltd</general><general>BioMed Central</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>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20150925</creationdate><title>Impact of tracheal cuff shape on microaspiration of gastric contents in intubated critically ill patients: study protocol for a randomized controlled trial</title><author>Jaillette, Emmanuelle ; Brunin, Guillaume ; Girault, Christophe ; Zerimech, Farid ; Chiche, Arnaud ; Broucqsault-Dedrie, Céline ; Fayolle, Cyril ; Minacori, Franck ; Alves, Isabelle ; Barrailler, Stephanie ; Robriquet, Laurent ; Tamion, Fabienne ; Delaporte, Emmanuel ; Thellier, Damien ; Delcourte, Claire ; Duhamel, Alain ; Nseir, Saad</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c494t-990419c8245569651a75064875f7d5da59d3219c352b40016d4af37affe8bdba3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Amylases - metabolism</topic><topic>Antibiotics</topic><topic>Bacterial pneumonia</topic><topic>Bacteriological Techniques</topic><topic>Biomarkers - metabolism</topic><topic>Bronchoscopy</topic><topic>Care and treatment</topic><topic>Chest Tubes - adverse effects</topic><topic>Clinical Enzyme Tests</topic><topic>Clinical Protocols</topic><topic>Clinical trials</topic><topic>Complications and side effects</topic><topic>Consent</topic><topic>Critical Illness</topic><topic>Cross-Over Studies</topic><topic>Development and progression</topic><topic>Enteral nutrition</topic><topic>Equipment Design</topic><topic>France</topic><topic>Gastrointestinal Contents - enzymology</topic><topic>Gastrointestinal Contents - microbiology</topic><topic>Health aspects</topic><topic>Humans</topic><topic>Intensive care</topic><topic>Intensive Care Units</topic><topic>Intervention</topic><topic>Intubation</topic><topic>Intubation, Intratracheal - adverse effects</topic><topic>Intubation, Intratracheal - instrumentation</topic><topic>Medical research</topic><topic>Medicine, Experimental</topic><topic>Microorganisms</topic><topic>Ostomy</topic><topic>Pathogenesis</topic><topic>Patient outcomes</topic><topic>Patients</topic><topic>Pepsin A - metabolism</topic><topic>Pneumonia</topic><topic>Pneumonia, Ventilator-Associated - diagnosis</topic><topic>Pneumonia, Ventilator-Associated - etiology</topic><topic>Pneumonia, Ventilator-Associated - microbiology</topic><topic>Pneumonia, Ventilator-Associated - prevention & control</topic><topic>Polyvinyl Chloride</topic><topic>Prevention</topic><topic>Prospective Studies</topic><topic>Research Design</topic><topic>Respiration, Artificial - adverse effects</topic><topic>Respiration, Artificial - instrumentation</topic><topic>Respiratory Aspiration of Gastric Contents - diagnosis</topic><topic>Respiratory Aspiration of Gastric Contents - etiology</topic><topic>Respiratory Aspiration of Gastric Contents - microbiology</topic><topic>Respiratory Aspiration of Gastric Contents - prevention & control</topic><topic>Risk Factors</topic><topic>Study Protocol</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Ventilators</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Jaillette, Emmanuelle</creatorcontrib><creatorcontrib>Brunin, Guillaume</creatorcontrib><creatorcontrib>Girault, Christophe</creatorcontrib><creatorcontrib>Zerimech, Farid</creatorcontrib><creatorcontrib>Chiche, Arnaud</creatorcontrib><creatorcontrib>Broucqsault-Dedrie, Céline</creatorcontrib><creatorcontrib>Fayolle, Cyril</creatorcontrib><creatorcontrib>Minacori, Franck</creatorcontrib><creatorcontrib>Alves, Isabelle</creatorcontrib><creatorcontrib>Barrailler, Stephanie</creatorcontrib><creatorcontrib>Robriquet, Laurent</creatorcontrib><creatorcontrib>Tamion, Fabienne</creatorcontrib><creatorcontrib>Delaporte, Emmanuel</creatorcontrib><creatorcontrib>Thellier, Damien</creatorcontrib><creatorcontrib>Delcourte, Claire</creatorcontrib><creatorcontrib>Duhamel, Alain</creatorcontrib><creatorcontrib>Nseir, Saad</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Access via ProQuest (Open Access)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Current controlled trials in cardiovascular medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jaillette, Emmanuelle</au><au>Brunin, Guillaume</au><au>Girault, Christophe</au><au>Zerimech, Farid</au><au>Chiche, Arnaud</au><au>Broucqsault-Dedrie, Céline</au><au>Fayolle, Cyril</au><au>Minacori, Franck</au><au>Alves, Isabelle</au><au>Barrailler, Stephanie</au><au>Robriquet, Laurent</au><au>Tamion, Fabienne</au><au>Delaporte, Emmanuel</au><au>Thellier, Damien</au><au>Delcourte, Claire</au><au>Duhamel, Alain</au><au>Nseir, Saad</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Impact of tracheal cuff shape on microaspiration of gastric contents in intubated critically ill patients: study protocol for a randomized controlled trial</atitle><jtitle>Current controlled trials in cardiovascular medicine</jtitle><addtitle>Trials</addtitle><date>2015-09-25</date><risdate>2015</risdate><volume>16</volume><issue>1</issue><spage>429</spage><epage>429</epage><pages>429-429</pages><artnum>429</artnum><issn>1745-6215</issn><eissn>1745-6215</eissn><abstract>Ventilator-associated pneumonia (VAP) is the most common infection in intubated critically ill patients. Microaspiration of the contaminated gastric and oropharyngeal secretions is the main mechanism involved in the pathophysiology of VAP. Tracheal cuff plays an important role in stopping the progression of contaminated secretions into the lower respiratory tract. Previous in vitro studies suggested that conical cuff shape might be helpful in improving tracheal sealing. However, clinical studies found conflicting results. The aim of this study is to determine the impact of conical tracheal cuff shape on the microaspiration of gastric contents in critically ill patients.
This prospective cluster randomized controlled crossover open-label trial is currently being conducted in ten French intensive care units (ICUs). Patients are allocated to intubation with a polyvinyl chloride (PVC) standard (barrel)-shaped or a PVC conical-shaped tracheal tube. The primary objective is to determine the impact of the conical shaped tracheal cuff on abundant microaspiration of gastric contents. Secondary outcomes include the incidence of microaspiration of oropharyngeal secretions, tracheobronchial colonization, VAP and ventilator-associated events. Abundant microaspiration is defined as the presence of pepsin at significant level (>200 ng/ml) in at least 30 % of the tracheal aspirates. Pepsin and amylase are quantitatively measured in all tracheal aspirates during the 48 h following inclusion. Quantitative tracheal aspirate culture is performed at inclusion and twice weekly. We plan to recruit 312 patients in the participating ICUs.
BEST Cuff is the first randomized controlled study evaluating the impact of PVC tracheal-cuff shape on gastric microaspirations in patients receiving invasive mechanical ventilation. Enrollment began in June 2014 and is expected to end in October 2015.
ClinicalTrials.gov Identifier: NCT01948635 (registered 31 August 2013).</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>26407612</pmid><doi>10.1186/s13063-015-0955-z</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Current controlled trials in cardiovascular medicine, 2015-09, Vol.16 (1), p.429-429, Article 429 |
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| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4583738 |
| source | MEDLINE; DOAJ Directory of Open Access Journals; SpringerNature Journals; PubMed Central Open Access; PubMed Central; Springer Nature OA/Free Journals |
| subjects | Amylases - metabolism Antibiotics Bacterial pneumonia Bacteriological Techniques Biomarkers - metabolism Bronchoscopy Care and treatment Chest Tubes - adverse effects Clinical Enzyme Tests Clinical Protocols Clinical trials Complications and side effects Consent Critical Illness Cross-Over Studies Development and progression Enteral nutrition Equipment Design France Gastrointestinal Contents - enzymology Gastrointestinal Contents - microbiology Health aspects Humans Intensive care Intensive Care Units Intervention Intubation Intubation, Intratracheal - adverse effects Intubation, Intratracheal - instrumentation Medical research Medicine, Experimental Microorganisms Ostomy Pathogenesis Patient outcomes Patients Pepsin A - metabolism Pneumonia Pneumonia, Ventilator-Associated - diagnosis Pneumonia, Ventilator-Associated - etiology Pneumonia, Ventilator-Associated - microbiology Pneumonia, Ventilator-Associated - prevention & control Polyvinyl Chloride Prevention Prospective Studies Research Design Respiration, Artificial - adverse effects Respiration, Artificial - instrumentation Respiratory Aspiration of Gastric Contents - diagnosis Respiratory Aspiration of Gastric Contents - etiology Respiratory Aspiration of Gastric Contents - microbiology Respiratory Aspiration of Gastric Contents - prevention & control Risk Factors Study Protocol Time Factors Treatment Outcome Ventilators |
| title | Impact of tracheal cuff shape on microaspiration of gastric contents in intubated critically ill patients: study protocol for a randomized controlled trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-16T23%3A16%3A25IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Impact%20of%20tracheal%20cuff%20shape%20on%20microaspiration%20of%20gastric%20contents%20in%20intubated%20critically%20ill%20patients:%20study%20protocol%20for%20a%20randomized%20controlled%20trial&rft.jtitle=Current%20controlled%20trials%20in%20cardiovascular%20medicine&rft.au=Jaillette,%20Emmanuelle&rft.date=2015-09-25&rft.volume=16&rft.issue=1&rft.spage=429&rft.epage=429&rft.pages=429-429&rft.artnum=429&rft.issn=1745-6215&rft.eissn=1745-6215&rft_id=info:doi/10.1186/s13063-015-0955-z&rft_dat=%3Cgale_pubme%3EA541597624%3C/gale_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2795282013&rft_id=info:pmid/26407612&rft_galeid=A541597624&rfr_iscdi=true |