A randomized trial of daily awakening in critically ill patients managed with a sedation protocol: A pilot trial
OBJECTIVE:Protocolized sedation (PS) and daily sedative interruption (DI) in critically ill patients have both been shown to shorten the durations of mechanical ventilation (MV) and intensive care unit (ICU) stay. Our objective was to determine the safety and feasibility of a randomized trial to det...
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| Veröffentlicht in: | Critical care medicine 2008-07, Vol.36 (7), p.2092-2099 |
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| container_title | Critical care medicine |
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| creator | Mehta, Sangeeta Burry, Lisa Martinez-Motta, J Carlos Stewart, Thomas E Hallett, David McDonald, Ellen Clarke, France MacDonald, Rod Granton, John Matte, Andrea Wong, Cindy Suri, Amit Cook, Deborah J |
| description | OBJECTIVE:Protocolized sedation (PS) and daily sedative interruption (DI) in critically ill patients have both been shown to shorten the durations of mechanical ventilation (MV) and intensive care unit (ICU) stay. Our objective was to determine the safety and feasibility of a randomized trial to determine whether adults managed with both PS + DI have a shorter duration of MV than patients managed with PS alone.
DESIGN:Prospective randomized, concealed, unblinded, multicenter, pilot trial.
SETTING:Three university-affiliated medical-surgical ICUs.
PATIENTS:Sixty-five adults anticipated to require MV >48 hrs and receiving sedative/analgesic infusions.
INTERVENTIONS:Patients were randomized to PS alone, or PS + DI. PS was implemented by bedside nurses; sedatives/analgesics were titrated to achieve Sedation Agitation Score (SAS) 3–4. The PS + DI group also had infusions interrupted daily until the patients awoke.
MEASUREMENTS AND MAIN RESULTS:Diagnosis, age [mean ± sd] (53 ± 18.3 vs. 62.1 ± 16.7 yrs) and Acute Physiology and Chronic Health Evaluation II (27.7 ± 8.4 vs. 26.6 ± 8.4) were similar in the PS and PS + DI groups, respectively. The median duration of MV in the PS and PS + DI groups was 8.0 vs. 10.5 days, and ICU stay was 10.0 vs. 13.0 days, respectively. The SAS was within target range (3–4) in 59% of 9,611 measurements, and within an acceptable range (2–5) in 86% of measurements. Self-assessed nursing and respiratory therapist workload was low in the majority of the cohort. Adverse events were similar in both groups. Patient recruitment was slower than projected (1.5 patients/mo).
CONCLUSION:This pilot trial comparing PS vs. PS + DI confirmed the safety and acceptability of the sedation protocol and DI, and guided important modifications to the protocol, thus enhancing the feasibility of a future multicenter trial. This trial was not designed to detect small but significant differences in clinically important outcomes. |
| doi_str_mv | 10.1097/CCM.0b013e31817bff85 |
| format | Article |
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DESIGN:Prospective randomized, concealed, unblinded, multicenter, pilot trial.
SETTING:Three university-affiliated medical-surgical ICUs.
PATIENTS:Sixty-five adults anticipated to require MV >48 hrs and receiving sedative/analgesic infusions.
INTERVENTIONS:Patients were randomized to PS alone, or PS + DI. PS was implemented by bedside nurses; sedatives/analgesics were titrated to achieve Sedation Agitation Score (SAS) 3–4. The PS + DI group also had infusions interrupted daily until the patients awoke.
MEASUREMENTS AND MAIN RESULTS:Diagnosis, age [mean ± sd] (53 ± 18.3 vs. 62.1 ± 16.7 yrs) and Acute Physiology and Chronic Health Evaluation II (27.7 ± 8.4 vs. 26.6 ± 8.4) were similar in the PS and PS + DI groups, respectively. The median duration of MV in the PS and PS + DI groups was 8.0 vs. 10.5 days, and ICU stay was 10.0 vs. 13.0 days, respectively. The SAS was within target range (3–4) in 59% of 9,611 measurements, and within an acceptable range (2–5) in 86% of measurements. Self-assessed nursing and respiratory therapist workload was low in the majority of the cohort. Adverse events were similar in both groups. Patient recruitment was slower than projected (1.5 patients/mo).
CONCLUSION:This pilot trial comparing PS vs. PS + DI confirmed the safety and acceptability of the sedation protocol and DI, and guided important modifications to the protocol, thus enhancing the feasibility of a future multicenter trial. This trial was not designed to detect small but significant differences in clinically important outcomes.</description><identifier>ISSN: 0090-3493</identifier><identifier>EISSN: 1530-0293</identifier><identifier>DOI: 10.1097/CCM.0b013e31817bff85</identifier><identifier>PMID: 18552687</identifier><identifier>CODEN: CCMDC7</identifier><language>eng</language><publisher>Hagerstown, MD: by the Society of Critical Care Medicine and Lippincott Williams & Wilkins</publisher><subject>Aged ; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy ; APACHE ; Biological and medical sciences ; Clinical death. Palliative care. Organ gift and preservation ; Conscious Sedation - adverse effects ; Conscious Sedation - classification ; Conscious Sedation - methods ; Critical Care - methods ; Female ; Hospital Mortality ; Humans ; Hypnotics and Sedatives ; Intensive care medicine ; Intensive Care Units ; Male ; Medical sciences ; Midazolam ; Middle Aged ; Morphine ; Neuromuscular Blocking Agents - pharmacology ; Pilot Projects ; Respiration, Artificial ; Safety ; Sleep - drug effects</subject><ispartof>Critical care medicine, 2008-07, Vol.36 (7), p.2092-2099</ispartof><rights>2008 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins</rights><rights>2008 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3845-610391d617b4f783e371ee2add5e90ea7a8de5d5cf82218d951aa9bc91dc90763</citedby><cites>FETCH-LOGICAL-c3845-610391d617b4f783e371ee2add5e90ea7a8de5d5cf82218d951aa9bc91dc90763</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20494609$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18552687$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mehta, Sangeeta</creatorcontrib><creatorcontrib>Burry, Lisa</creatorcontrib><creatorcontrib>Martinez-Motta, J Carlos</creatorcontrib><creatorcontrib>Stewart, Thomas E</creatorcontrib><creatorcontrib>Hallett, David</creatorcontrib><creatorcontrib>McDonald, Ellen</creatorcontrib><creatorcontrib>Clarke, France</creatorcontrib><creatorcontrib>MacDonald, Rod</creatorcontrib><creatorcontrib>Granton, John</creatorcontrib><creatorcontrib>Matte, Andrea</creatorcontrib><creatorcontrib>Wong, Cindy</creatorcontrib><creatorcontrib>Suri, Amit</creatorcontrib><creatorcontrib>Cook, Deborah J</creatorcontrib><creatorcontrib>Canadian Critical Care Trials Group</creatorcontrib><title>A randomized trial of daily awakening in critically ill patients managed with a sedation protocol: A pilot trial</title><title>Critical care medicine</title><addtitle>Crit Care Med</addtitle><description>OBJECTIVE:Protocolized sedation (PS) and daily sedative interruption (DI) in critically ill patients have both been shown to shorten the durations of mechanical ventilation (MV) and intensive care unit (ICU) stay. Our objective was to determine the safety and feasibility of a randomized trial to determine whether adults managed with both PS + DI have a shorter duration of MV than patients managed with PS alone.
DESIGN:Prospective randomized, concealed, unblinded, multicenter, pilot trial.
SETTING:Three university-affiliated medical-surgical ICUs.
PATIENTS:Sixty-five adults anticipated to require MV >48 hrs and receiving sedative/analgesic infusions.
INTERVENTIONS:Patients were randomized to PS alone, or PS + DI. PS was implemented by bedside nurses; sedatives/analgesics were titrated to achieve Sedation Agitation Score (SAS) 3–4. The PS + DI group also had infusions interrupted daily until the patients awoke.
MEASUREMENTS AND MAIN RESULTS:Diagnosis, age [mean ± sd] (53 ± 18.3 vs. 62.1 ± 16.7 yrs) and Acute Physiology and Chronic Health Evaluation II (27.7 ± 8.4 vs. 26.6 ± 8.4) were similar in the PS and PS + DI groups, respectively. The median duration of MV in the PS and PS + DI groups was 8.0 vs. 10.5 days, and ICU stay was 10.0 vs. 13.0 days, respectively. The SAS was within target range (3–4) in 59% of 9,611 measurements, and within an acceptable range (2–5) in 86% of measurements. Self-assessed nursing and respiratory therapist workload was low in the majority of the cohort. Adverse events were similar in both groups. Patient recruitment was slower than projected (1.5 patients/mo).
CONCLUSION:This pilot trial comparing PS vs. PS + DI confirmed the safety and acceptability of the sedation protocol and DI, and guided important modifications to the protocol, thus enhancing the feasibility of a future multicenter trial. This trial was not designed to detect small but significant differences in clinically important outcomes.</description><subject>Aged</subject><subject>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</subject><subject>APACHE</subject><subject>Biological and medical sciences</subject><subject>Clinical death. Palliative care. Organ gift and preservation</subject><subject>Conscious Sedation - adverse effects</subject><subject>Conscious Sedation - classification</subject><subject>Conscious Sedation - methods</subject><subject>Critical Care - methods</subject><subject>Female</subject><subject>Hospital Mortality</subject><subject>Humans</subject><subject>Hypnotics and Sedatives</subject><subject>Intensive care medicine</subject><subject>Intensive Care Units</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Midazolam</subject><subject>Middle Aged</subject><subject>Morphine</subject><subject>Neuromuscular Blocking Agents - pharmacology</subject><subject>Pilot Projects</subject><subject>Respiration, Artificial</subject><subject>Safety</subject><subject>Sleep - drug effects</subject><issn>0090-3493</issn><issn>1530-0293</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kMFu1DAQhi1ERbeFN0DIF7ilteM4trmtVoUiFXGBczRrT7qmThxsr1bt09doVyBx4GRp_P2_Zj5C3nJ2xZlR15vN1yu2ZVyg4Jqr7Thq-YKsuBSsYa0RL8mKMcMa0RlxTi5y_skY76QSr8g511K2vVYrsqxpgtnFyT-hoyV5CDSO1IEPjxQO8ICzn--pn6lNvngLoc59CHSB4nEumU4ww33NHnzZUaAZXf2JM11SLNHG8JGu6eJDLMf21-RshJDxzem9JD8-3Xzf3DZ33z5_2azvGit0J5ueM2G46-th3ah0PVJxxBack2gYggLtUDppR922XDsjOYDZ2pqxhqleXJIPx966x6895jJMPlsMAWaM-zz0ptW9UV0FuyNoU8w54TgsyU-QHgfOht-mh2p6-Nd0jb079e-3E7q_oZPaCrw_AZCrtrFqtj7_4VrWma5npnL6yB1iKJjyQ9gfMA07hFB2_9_hGTeUmzk</recordid><startdate>200807</startdate><enddate>200807</enddate><creator>Mehta, Sangeeta</creator><creator>Burry, Lisa</creator><creator>Martinez-Motta, J Carlos</creator><creator>Stewart, Thomas E</creator><creator>Hallett, David</creator><creator>McDonald, Ellen</creator><creator>Clarke, France</creator><creator>MacDonald, Rod</creator><creator>Granton, John</creator><creator>Matte, Andrea</creator><creator>Wong, Cindy</creator><creator>Suri, Amit</creator><creator>Cook, Deborah J</creator><general>by the Society of Critical Care Medicine and Lippincott Williams & Wilkins</general><general>Lippincott</general><scope>IQODW</scope><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>7X8</scope></search><sort><creationdate>200807</creationdate><title>A randomized trial of daily awakening in critically ill patients managed with a sedation protocol: A pilot trial</title><author>Mehta, Sangeeta ; Burry, Lisa ; Martinez-Motta, J Carlos ; Stewart, Thomas E ; Hallett, David ; McDonald, Ellen ; Clarke, France ; MacDonald, Rod ; Granton, John ; Matte, Andrea ; Wong, Cindy ; Suri, Amit ; Cook, Deborah J</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3845-610391d617b4f783e371ee2add5e90ea7a8de5d5cf82218d951aa9bc91dc90763</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Aged</topic><topic>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</topic><topic>APACHE</topic><topic>Biological and medical sciences</topic><topic>Clinical death. Palliative care. Organ gift and preservation</topic><topic>Conscious Sedation - adverse effects</topic><topic>Conscious Sedation - classification</topic><topic>Conscious Sedation - methods</topic><topic>Critical Care - methods</topic><topic>Female</topic><topic>Hospital Mortality</topic><topic>Humans</topic><topic>Hypnotics and Sedatives</topic><topic>Intensive care medicine</topic><topic>Intensive Care Units</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Midazolam</topic><topic>Middle Aged</topic><topic>Morphine</topic><topic>Neuromuscular Blocking Agents - pharmacology</topic><topic>Pilot Projects</topic><topic>Respiration, Artificial</topic><topic>Safety</topic><topic>Sleep - drug effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mehta, Sangeeta</creatorcontrib><creatorcontrib>Burry, Lisa</creatorcontrib><creatorcontrib>Martinez-Motta, J Carlos</creatorcontrib><creatorcontrib>Stewart, Thomas E</creatorcontrib><creatorcontrib>Hallett, David</creatorcontrib><creatorcontrib>McDonald, Ellen</creatorcontrib><creatorcontrib>Clarke, France</creatorcontrib><creatorcontrib>MacDonald, Rod</creatorcontrib><creatorcontrib>Granton, John</creatorcontrib><creatorcontrib>Matte, Andrea</creatorcontrib><creatorcontrib>Wong, Cindy</creatorcontrib><creatorcontrib>Suri, Amit</creatorcontrib><creatorcontrib>Cook, Deborah J</creatorcontrib><creatorcontrib>Canadian Critical Care Trials Group</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Critical care medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mehta, Sangeeta</au><au>Burry, Lisa</au><au>Martinez-Motta, J Carlos</au><au>Stewart, Thomas E</au><au>Hallett, David</au><au>McDonald, Ellen</au><au>Clarke, France</au><au>MacDonald, Rod</au><au>Granton, John</au><au>Matte, Andrea</au><au>Wong, Cindy</au><au>Suri, Amit</au><au>Cook, Deborah J</au><aucorp>Canadian Critical Care Trials Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A randomized trial of daily awakening in critically ill patients managed with a sedation protocol: A pilot trial</atitle><jtitle>Critical care medicine</jtitle><addtitle>Crit Care Med</addtitle><date>2008-07</date><risdate>2008</risdate><volume>36</volume><issue>7</issue><spage>2092</spage><epage>2099</epage><pages>2092-2099</pages><issn>0090-3493</issn><eissn>1530-0293</eissn><coden>CCMDC7</coden><abstract>OBJECTIVE:Protocolized sedation (PS) and daily sedative interruption (DI) in critically ill patients have both been shown to shorten the durations of mechanical ventilation (MV) and intensive care unit (ICU) stay. Our objective was to determine the safety and feasibility of a randomized trial to determine whether adults managed with both PS + DI have a shorter duration of MV than patients managed with PS alone.
DESIGN:Prospective randomized, concealed, unblinded, multicenter, pilot trial.
SETTING:Three university-affiliated medical-surgical ICUs.
PATIENTS:Sixty-five adults anticipated to require MV >48 hrs and receiving sedative/analgesic infusions.
INTERVENTIONS:Patients were randomized to PS alone, or PS + DI. PS was implemented by bedside nurses; sedatives/analgesics were titrated to achieve Sedation Agitation Score (SAS) 3–4. The PS + DI group also had infusions interrupted daily until the patients awoke.
MEASUREMENTS AND MAIN RESULTS:Diagnosis, age [mean ± sd] (53 ± 18.3 vs. 62.1 ± 16.7 yrs) and Acute Physiology and Chronic Health Evaluation II (27.7 ± 8.4 vs. 26.6 ± 8.4) were similar in the PS and PS + DI groups, respectively. The median duration of MV in the PS and PS + DI groups was 8.0 vs. 10.5 days, and ICU stay was 10.0 vs. 13.0 days, respectively. The SAS was within target range (3–4) in 59% of 9,611 measurements, and within an acceptable range (2–5) in 86% of measurements. Self-assessed nursing and respiratory therapist workload was low in the majority of the cohort. Adverse events were similar in both groups. Patient recruitment was slower than projected (1.5 patients/mo).
CONCLUSION:This pilot trial comparing PS vs. PS + DI confirmed the safety and acceptability of the sedation protocol and DI, and guided important modifications to the protocol, thus enhancing the feasibility of a future multicenter trial. This trial was not designed to detect small but significant differences in clinically important outcomes.</abstract><cop>Hagerstown, MD</cop><pub>by the Society of Critical Care Medicine and Lippincott Williams & Wilkins</pub><pmid>18552687</pmid><doi>10.1097/CCM.0b013e31817bff85</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0090-3493 |
| ispartof | Critical care medicine, 2008-07, Vol.36 (7), p.2092-2099 |
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| language | eng |
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| source | MEDLINE; Journals@Ovid Complete |
| subjects | Aged Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy APACHE Biological and medical sciences Clinical death. Palliative care. Organ gift and preservation Conscious Sedation - adverse effects Conscious Sedation - classification Conscious Sedation - methods Critical Care - methods Female Hospital Mortality Humans Hypnotics and Sedatives Intensive care medicine Intensive Care Units Male Medical sciences Midazolam Middle Aged Morphine Neuromuscular Blocking Agents - pharmacology Pilot Projects Respiration, Artificial Safety Sleep - drug effects |
| title | A randomized trial of daily awakening in critically ill patients managed with a sedation protocol: A pilot trial |
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