Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial

Girard, Timothy D.; Kress, John P.; Fuchs, Barry D.; Thomason, Jason W. W.; Schweickert, William D.; Pun, Brenda T.; Taichman, Darren B.; Dunn, Jan; Pohlman, Anne S.; Kinniry, Paul; Jackson, James C.; Canonico, Angelo E.; Light, Richard W.; Shintani, Ayumi; Thompson, Jennifer L.; Gordon, Sharon M.; Hall, Jesse B.; Dittus, Robert S.; Bernard, Gordon R.; Ely, E. Wesley

doi:10.1016/s0140-6736(08)60105-1

Cited by 1,753 publications

(1,290 citation statements)

References 35 publications

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“…A positive consequence of these clinical definitions has been the identification of intensive care unit practices that are effective for the broader critically ill population, such as sedation and ventilator liberation practices (21), lower tidal volume ventilation (7), and early mobility (22). For many of these therapies, the clinically defined syndrome may even be too narrow a target population, as patients without the syndrome may still benefit.…”

Section: Why Lump?mentioning

confidence: 99%

Toward Smarter Lumping and Smarter Splitting: Rethinking Strategies for Sepsis and Acute Respiratory Distress Syndrome Clinical Trial Design

Prescott

Calfee

Thompson

et al. 2016

Am J Respir Crit Care Med

264

228

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Both quality improvement and clinical research efforts over the past few decades have focused on consensus definition of sepsis and acute respiratory distress syndrome (ARDS). Although clinical definitions based on readily available clinical data have advanced recognition and timely use of broad supportive treatments, they likely hinder the identification of more targeted therapies that manipulate select biological mechanisms underlying critical illness. Sepsis and ARDS are by definition heterogeneous, and patients vary in both their underlying biology and their severity of illness. We have long been able to identify subtypes of sepsis and ARDS that confer different prognoses. The key is that we are now on the verge of identifying subtypes that may confer different response to therapy. In this perspective, inspired by a 2015 American Thoracic Society International Conference Symposium entitled "Lumpers and Splitters: Phenotyping in Critical Illness," we highlight promising approaches to uncovering patient subtypes that may predict treatment responsiveness and not just differences in prognosis. We then discuss how this information can be leveraged to improve the success and translatability of clinical trials by using predictive enrichment and other design strategies. Last, we discuss the challenges and limitations to identifying biomarkers and endotypes and incorporating them into routine clinical practice.

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Section: Why Lump?mentioning

confidence: 99%

Toward Smarter Lumping and Smarter Splitting: Rethinking Strategies for Sepsis and Acute Respiratory Distress Syndrome Clinical Trial Design

Prescott

Calfee

Thompson

et al. 2016

Am J Respir Crit Care Med

264

228

View full text Add to dashboard Cite

show abstract

“…As it is clear that excessively sustained sedation unnecessarily prolongs mechanical ventilation periods due to factors such as the onset of ventilator‐associated pneumonia and unsuccessful weaning trials,233, 234, 235, 236 the mainstream approach is shifting from “hypnosis‐focused sedation” to a “minimum sedation.” Preventing hallucinations and delusions is also important, and to do this, attending physicians should “avoid unnecessary sedation.” The safety of early‐stage rehabilitation in critically‐ill patients has also been pointed out,237 but reports made around the same time have highlighted how rehabilitation measures are infrequently implemented 238, 239. The issue of “excessive sedation” has been raised as a possible reason.…”

Section: Introductionmentioning

confidence: 99%

The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J‐SSCG 2016)

Nishida

Ogura

Egi

et al. 2018

Acute Medicine & Surgery

157

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Background and PurposeThe Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J‐SSCG 2016), a Japanese‐specific set of clinical practice guidelines for sepsis and septic shock created jointly by the Japanese Society of Intensive Care Medicine and the Japanese Association for Acute Medicine, was first released in February 2017 in Japanese. An English‐language version of these guidelines was created based on the contents of the original Japanese‐language version.MethodsMembers of the Japanese Society of Intensive Care Medicine and the Japanese Association for Acute Medicine were selected and organized into 19 committee members and 52 working group members. The guidelines were prepared in accordance with the Medical Information Network Distribution Service (Minds) creation procedures. The Academic Guidelines Promotion Team was organized to oversee and provide academic support to the respective activities allocated to each Guideline Creation Team. To improve quality assurance and workflow transparency, a mutual peer review system was established, and discussions within each team were open to the public. Public comments were collected once after the initial formulation of a clinical question (CQ), and twice during the review of the final draft. Recommendations were determined to have been adopted after obtaining support from a two‐thirds (>66.6%) majority vote of each of the 19 committee members.ResultsA total of 87 CQs were selected among 19 clinical areas, including pediatric topics and several other important areas not covered in the first edition of the Japanese guidelines (J‐SSCG 2012). The approval rate obtained through committee voting, in addition to ratings of the strengths of the recommendation and its supporting evidence were also added to each recommendation statement. We conducted meta‐analyses for 29 CQs. Thirty seven CQs contained recommendations in the form of an expert consensus due to insufficient evidence. No recommendations were provided for 5 CQs.ConclusionsBased on the evidence gathered, we were able to formulate Japanese‐specific clinical practice guidelines that are tailored to the Japanese context in a highly transparent manner. These guidelines can easily be used not only by specialists, but also by non‐specialists, general clinicians, nurses, pharmacists, clinical engineers, and other healthcare professionals.

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“…In this single-centre trial, sedation infusions were titrated to achieve a score of 3-4 on the Ramsay sedation scale that categorizes sedation from 0 (agitated or restless) to 6 (asleep and unresponsive to stimuli). 8 This RCT was followed by a four-centre RCT involving 336 patients whose daily interruption of sedation infusions was combined with a daily spontaneous breathing trial (the Awakening and Breathing Controlled trial) 9 to assess patients for tracheal extubation. The group receiving this intervention was compared with a control group that was also assessed for daily spontaneous breathing and sedation scales were employed.…”

mentioning

confidence: 99%

Optimizing the approach to pain, agitation, and delirium in critical care

Friedrich

Baker

2014

Can J Anesth/J Can Anesth

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Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial

Cited by 1,753 publications

References 35 publications

Toward Smarter Lumping and Smarter Splitting: Rethinking Strategies for Sepsis and Acute Respiratory Distress Syndrome Clinical Trial Design

Toward Smarter Lumping and Smarter Splitting: Rethinking Strategies for Sepsis and Acute Respiratory Distress Syndrome Clinical Trial Design

The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J‐SSCG 2016)

Optimizing the approach to pain, agitation, and delirium in critical care

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