19
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Patient safety during procedural sedation using capnography monitoring: a systematic review and meta-analysis

      systematic-review

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Objective

          To evaluate the effect of capnography monitoring on sedation-related adverse events during procedural sedation and analgesia (PSA) administered for ambulatory surgery relative to visual assessment and pulse oximetry alone.

          Design and setting

          Systematic literature review and random effects meta-analysis of randomised controlled trials (RCTs) reporting sedation-related adverse event incidence when adding capnography to visual assessment and pulse oximetry in patients undergoing PSA during ambulatory surgery in the hospital setting. Searches for eligible studies published between 1 January 1995 and 31 December 2016 (inclusive) were conducted in PubMed, the Cochrane Library and EMBASE without any language constraints. Searches were conducted in January 2017, screening and data extraction were conducted by two independent reviewers, and study quality was assessed using a modified Jadad scale.

          Interventions

          Capnography monitoring relative to visual assessment and pulse oximetry alone.

          Primary and secondary outcome measures

          Predefined endpoints of interest were desaturation/hypoxaemia (the primary endpoint), apnoea, aspiration, bradycardia, hypotension, premature procedure termination, respiratory failure, use of assisted/bag-mask ventilation and death during PSA.

          Results

          The literature search identified 1006 unique articles, of which 13 were ultimately included in the meta-analysis. Addition of capnography to visual assessment and pulse oximetry was associated with a significant reduction in mild (risk ratio (RR) 0.77, 95% CI 0.67 to 0.89) and severe (RR 0.59, 95% CI 0.43 to 0.81) desaturation, as well as in the use of assisted ventilation (OR 0.47, 95% CI 0.23 to 0.95). No significant differences in other endpoints were identified.

          Conclusions

          Meta-analysis of 13 RCTs published between 2006 and 2016 showed a reduction in respiratory compromise (from respiratory insufficiency to failure) during PSA with the inclusion of capnography monitoring. In particular, use of capnography was associated with less mild and severe oxygen desaturation, which may have helped to avoid the need for assisted ventilation.

          Related collections

          Most cited references38

          • Record: found
          • Abstract: found
          • Article: not found

          Pharmaceutical industry sponsorship and research outcome and quality: systematic review.

          To investigate whether funding of drug studies by the pharmaceutical industry is associated with outcomes that are favourable to the funder and whether the methods of trials funded by pharmaceutical companies differ from the methods in trials with other sources of support. Medline (January 1966 to December 2002) and Embase (January 1980 to December 2002) searches were supplemented with material identified in the references and in the authors' personal files. Data were independently abstracted by three of the authors and disagreements were resolved by consensus. 30 studies were included. Research funded by drug companies was less likely to be published than research funded by other sources. Studies sponsored by pharmaceutical companies were more likely to have outcomes favouring the sponsor than were studies with other sponsors (odds ratio 4.05; 95% confidence interval 2.98 to 5.51; 18 comparisons). None of the 13 studies that analysed methods reported that studies funded by industry was of poorer quality. Systematic bias favours products which are made by the company funding the research. Explanations include the selection of an inappropriate comparator to the product being investigated and publication bias.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Discrepancies between meta-analyses and subsequent large randomized, controlled trials.

            Meta-analyses are now widely used to provide evidence to support clinical strategies. However, large randomized, controlled trials are considered the gold standard in evaluating the efficacy of clinical interventions. We compared the results of large randomized, controlled trials (involving 1000 patients or more) that were published in four journals (the New England Journal of Medicine, the Lancet, the Annals of Internal Medicine, and the Journal of the American Medical Association) with the results of meta-analyses published earlier on the same topics. Regarding the principal and secondary outcomes, we judged whether the findings of the randomized trials agreed with those of the corresponding meta-analyses, and we determined whether the study results were positive (indicating that treatment improved the outcome) or negative (indicating that the outcome with treatment was the same or worse than without it) at the conventional level of statistical significance (P<0.05). We identified 12 large randomized, controlled trials and 19 meta-analyses addressing the same questions. For a total of 40 primary and secondary outcomes, agreement between the meta-analyses and the large clinical trials was only fair (kappa= 0.35; 95 percent confidence interval, 0.06 to 0.64). The positive predictive value of the meta-analyses was 68 percent, and the negative predictive value 67 percent. However, the difference in point estimates between the randomized trials and the meta-analyses was statistically significant for only 5 of the 40 comparisons (12 percent). Furthermore, in each case of disagreement a statistically significant effect of treatment was found by one method, whereas no statistically significant effect was found by the other. The outcomes of the 12 large randomized, controlled trials that we studied were not predicted accurately 35 percent of the time by the meta-analyses published previously on the same topics.
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              How to calculate sample size in randomized controlled trial?

              To design clinical trials, efficiency, ethics, cost effectively, research duration and sample size calculations are the key things to remember. This review highlights the statistical issues to estimate the sample size requirement. It elaborates the theory, methods and steps for the sample size calculation in randomized controlled trials. It also emphasizes that researchers should consider the study design first and then choose appropriate sample size calculation method.
                Bookmark

                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2017
                30 June 2017
                : 7
                : 6
                : e013402
                Affiliations
                [1 ] Coreva Scientific GmbH & Co. KG. , Freiburg, Germany
                [2 ] Ossian Health Economics and Communications , Basel, Switzerland
                [3 ] departmentDepartment of Anesthesiology , University of Groningen, University Medical Center Groningen , Groningen, The Netherlands
                [4 ] departmentDepartment of Anesthesia , Ghent University , Ghent, Belgium
                [5 ] departmentMinimally Invasive Therapies Group , Medtronic , Boulder, Colorado, USA
                [6 ] departmentDivision of Pediatric Gastroenterology , UMass Memorial Children’s Medical Center , Westborough, Massachusetts, USA
                [7 ] departmentDepartment of Pediatrics , University of Massachusetts Medical School , Worcester, Massachusetts, USA
                Author notes
                [Correspondence to ] Richard F Pollock; pollock@ 123456ossianconsulting.com
                Author information
                http://orcid.org/0000-0002-9873-7507
                Article
                bmjopen-2016-013402
                10.1136/bmjopen-2016-013402
                5734204
                28667196
                868390e6-f7e2-4dbd-9678-92462db49219
                © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

                History
                : 13 July 2016
                : 22 March 2017
                : 23 March 2017
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100004374, Medtronic;
                Categories
                Anaesthesia
                Research
                1506
                1682
                Custom metadata
                unlocked

                Medicine
                capnography,meta-analysis,procedural sedation,ambulatory surgery
                Medicine
                capnography, meta-analysis, procedural sedation, ambulatory surgery

                Comments

                Comment on this article