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1.
Crit Care Med ; 45(9): 1538-1545, 2017 Sep.
Article in English | MEDLINE | ID: mdl-28817481

ABSTRACT

OBJECTIVE: Dynamic tests of fluid responsiveness have been developed and investigated in clinical trials of goal-directed therapy. The impact of this approach on clinically relevant outcomes is unknown. We performed a systematic review and meta-analysis to evaluate whether fluid therapy guided by dynamic assessment of fluid responsiveness compared with standard care improves clinically relevant outcomes in adults admitted to the ICU. DATA SOURCES: Randomized controlled trials from MEDLINE, EMBASE, CENTRAL, clinicaltrials.gov, and the International Clinical Trials Registry Platform from inception to December 2016, conference proceedings, and reference lists of relevant articles. STUDY SELECTION: Two reviewers independently identified randomized controlled trials comparing dynamic assessment of fluid responsiveness with standard care for acute volume resuscitation in adults admitted to the ICU. DATA EXTRACTION: Two reviewers independently abstracted trial-level data including population characteristics, interventions, clinical outcomes, and source of funding. Our primary outcome was mortality at longest duration of follow-up. Our secondary outcomes were ICU and hospital length of stay, duration of mechanical ventilation, and frequency of renal complications. The internal validity of trials was assessed in duplicate using the Cochrane Collaboration's Risk of Bias tool. DATA SYNTHESIS: We included 13 trials enrolling 1,652 patients. Methods used to assess fluid responsiveness included stroke volume variation (nine trials), pulse pressure variation (one trial), and stroke volume change with passive leg raise/fluid challenge (three trials). In 12 trials reporting mortality, the risk ratio for death associated with dynamic assessment of fluid responsiveness was 0.59 (95% CI, 0.42-0.83; I = 0%; n = 1,586). The absolute risk reduction in mortality associated with dynamic assessment of fluid responsiveness was -2.9% (95% CI, -5.6% to -0.2%). Dynamic assessment of fluid responsiveness was associated with reduced duration of ICU length of stay (weighted mean difference, -1.16 d [95% CI, -1.97 to -0.36]; I = 74%; n = 394, six trials) and mechanical ventilation (weighted mean difference, -2.98 hr [95% CI, -5.08 to -0.89]; I = 34%; n = 334, five trials). Three trials were adjudicated at unclear risk of bias; the remaining trials were at high risk of bias. CONCLUSIONS: In adult patients admitted to intensive care who required acute volume resuscitation, goal-directed therapy guided by assessment of fluid responsiveness appears to be associated with reduced mortality, ICU length of stay, and duration of mechanical ventilation. High-quality clinical trials in both medical and surgical ICU populations are warranted to inform routine care.


Subject(s)
Fluid Therapy/methods , Intensive Care Units/organization & administration , Resuscitation/methods , Acute Kidney Injury/epidemiology , Hospital Mortality , Humans , Length of Stay/statistics & numerical data , Patient Care Planning , Randomized Controlled Trials as Topic , Respiration, Artificial/statistics & numerical data , Resuscitation/mortality , Time Factors
2.
Anesth Analg ; 125(4): 1292-1300, 2017 10.
Article in English | MEDLINE | ID: mdl-28704247

ABSTRACT

BACKGROUND: Randomized clinical trials (RCTs) provide high-quality evidence for clinical decision-making. Trial registration is one of the many tools used to improve the reporting of RCTs by reducing publication bias and selective outcome reporting bias. The purpose of our study is to examine whether RCTs published in the top 6 general anesthesiology journals were adequately registered and whether the reported primary and secondary outcomes corresponded to the originally registered outcomes. METHODS: Following a prespecified protocol, an electronic database was used to systematically screen and extract data from RCTs published in the top 6 general anesthesiology journals by impact factor (Anaesthesia, Anesthesia & Analgesia, Anesthesiology, British Journal of Anaesthesia, Canadian Journal of Anesthesia, and European Journal of Anaesthesiology) during the years 2007, 2010, 2013, and 2015. A manual search of each journal's Table of Contents was performed (in duplicate) to identify eligible RCTs. An adequately registered trial was defined as being registered in a publicly available trials registry before the first patient being enrolled with an unambiguously defined primary outcome. For adequately registered trials, the outcomes registered in the trial registry were compared with the outcomes reported in the article, with outcome discrepancies documented and analyzed by the type of discrepancy. RESULTS: During the 4 years studied, there were 860 RCTs identified, with 102 RCTs determined to be adequately registered (12%). The proportion of adequately registered trials increased over time, with 38% of RCTs being adequately registered in 2015. The most common reason in 2015 for inadequate registration was registering the RCT after the first patient had already been enrolled. Among adequately registered trials, 92% had at least 1 primary or secondary outcome discrepancy. In 2015, 42% of RCTs had at least 1 primary outcome discrepancy, while 90% of RCTs had at least 1 secondary outcome discrepancy. CONCLUSIONS: Despite trial registration being an accepted best practice, RCTs published in anesthesiology journals have a high rate of inadequate registration. While mandating trial registration has increased the proportion of adequately registered trials over time, there is still an unacceptably high proportion of inadequately registered RCTs. Among adequately registered trials, there are high rates of discrepancies between registered and reported outcomes, suggesting a need to compare a published RCT with its trial registry entry to be able to fully assess the quality of the study. If clinicians base their decisions on evidence distorted by primary outcome switching, patient care could be negatively affected.


Subject(s)
Anesthesiology/standards , Periodicals as Topic/standards , Randomized Controlled Trials as Topic/standards , Registries/standards , Research Report/standards , Anesthesiology/methods , Humans , Journal Impact Factor , Randomized Controlled Trials as Topic/methods , Treatment Outcome
3.
Anesth Analg ; 122(3): 753-757, 2016 Mar.
Article in English | MEDLINE | ID: mdl-26771266

ABSTRACT

BACKGROUND: The GlideScope videolaryngoscope is an intubating device routinely used by anesthesiologists for tracheal intubation. It is occasionally difficult to advance the endotracheal tube (ETT) into the trachea, despite a good view of the glottis. One technique that may be used when difficulty is encountered is to remove the GlideScope from the pharynx and introduce the ETT into the pharynx first, leaving it in place posteriorly while the GlideScope is inserted. Frequently, when the GlideScope is subsequently inserted, the ETT tip will then be in good view, resting near the glottis, and will easily advance into the trachea. In this randomized, single-blinded trial, we assessed whether orotracheal intubation with the GlideScope is faster and/or easier with the ETT-first technique as a primary technique in elective patients. METHODS: One hundred sixty patients with normal-appearing airways who required elective orotracheal intubation were allocated randomly to intubation with insertion of the ETT or GlideScope into the oropharynx first. The primary outcome was time to intubation. The secondary outcomes were subjective ease of intubation (100-mm visual analog scale, 0 = easy; 100 = difficult), number of attempts/failures, incidence of oropharyngeal bleeding, and postoperative sore throat and/or vocal changes. RESULTS: Baseline demographics were similar between the 2 groups. Mean time to intubation was 48.2 ± 17.1 seconds with the ETT-first technique and 51.5 ± 21.8 seconds with the GlideScope-first technique (P = 0.30). The mean difference was 3.3 seconds in favor of the ETT-first technique (95% confidence interval, -2.9 to 9.6). The median ease of intubation using the visual analog scale was 13.3 mm (interquartile range, 5.3 to 21) with the ETT-first technique and 13.5 mm (interquartile range, 5.6 to 29.5) with the GlideScope-first technique (P = 0.30). The difference between the medians was -2.0 mm in favor of the ETT-first group (95% confidence interval, -1.5 to 6.0). There was no difference between groups for number of intubation attempts, incidence of oropharyngeal bleeding, laryngoscopic grade, sore throat, or vocal changes. CONCLUSIONS: In this study of GlideScope laryngoscopy, no statistically significant difference was observed in the time to intubate or the subjective ease of intubation whether the ETT or GlideScope was inserted into the oropharynx first.


Subject(s)
Intubation, Intratracheal/methods , Laryngoscopes , Laryngoscopy , Adult , Aged , Elective Surgical Procedures , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Single-Blind Method , Treatment Failure , Treatment Outcome , Video Recording
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