Effectiveness and risks of cricoid pressure during rapid sequence induction for endotracheal intubation.

BACKGROUND: Rapid sequence induction (RSI) for endotracheal intubation is a technique widely used in anaesthesia, emergency and intensive care medicine to secure an airway in patients deemed at risk of pulmonary aspiration. Cricoid pressure is conceptually used to reduce the risk of aspiration by compressing the oesophagus. OBJECTIVES: To identify and evaluate all randomized controlled trials (RCTs) involving participants undergoing elective or emergency airway management via RSI and compare participants who have cricoid pressure administered with participants who do not have cricoid pressure administered. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 4), MEDLINE via OvidSP (1946 to May 2015), EMBASE via OvidSP (1980 to May 2015), ISI Web of Science (from 1940 to May 2015) and CINAHL via EBSCOhost (1982 to May 2015). SELECTION CRITERIA: We included all RCTs comparing people undergoing RSI who have cricoid pressure applied, either intermittently or continuously, with people undergoing RSI who do not have cricoid pressure applied in the context of endotracheal intubation using a direct laryngoscopic technique. We included both elective and emergency cases. We included studies of blinded and unblinded participants. Participants (male or female) were involved in any type of procedure where general anaesthetic utilizing RSI or emergency airway management utilizing RSI and endotracheal intubation was undertaken. We expected the control arm to be the absence of cricoid pressure at any stage during RSI. The primary outcome of interest was the reported event rate or prevalence of aspiration determined by a) documented gastric aspiration determined by visual inspection of aspirated stomach contents on laryngoscopy; b) pepsin detection in tracheal aspirate using the Ufberg method; c) post-anaesthetic radiographic changes suggestive of aspiration pneumonitis or d) any combination of a to c. Secondary outcomes of interest included documented impaired visualization of the airway by a treating laryngoscopist, force applied during cricoid pressure, the direction of application of force of applied cricoid pressure, independent risk factors for aspiration and whether the person applying cricoid pressure had previously done so in an emergency airway context. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the titles and abstracts of all the studies obtained from the search using recognition of words such as 'cricoid pressure', 'rapid sequence intubation', 'emergency airway management' and 'aspiration'. Two authors independently determined the study inclusion by using a study eligibility form that we developed for the purpose of this review. We also reported the decisions regarding inclusion and exclusion in accordance with the preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement. We assumed that studies that did not describe the use of RSI in their title, abstract or methodology used an alternative method of anaesthetic induction or emergency airway management and thus we excluded them. Data extracted from included studies comprised study characteristics, participant demographics, intervention and comparison details plus outcome measures and results. We contacted primary authors of studies with missing or unreported but potentially relevant data to obtain missing data. MAIN RESULTS: Of 493 records that we identified from databases as a result of the search (excluding duplicates), we regarded 70 abstracts/titles as potentially relevant studies. Independent scrutiny of these 70 titles and abstracts identified 29 potentially relevant studies. Of the 29 potentially relevant studies, one study met the criteria for inclusion. This study was a RCT that compared participants undergoing RSI and endotracheal intubation in the context of elective surgery requiring a general anaesthetic. Forty participants were recruited, 20 of whom had cricoid pressure applied and 20 of whom had cricoid pressure simulated. The main outcomes reported were systolic arterial pressure and heart rate after laryngoscopy and tracheal intubation. We did not consider these outcomes relevant for the purposes of this systematic review. The search also identified one study that could potentially be included in an updated systematic review in the future, but was at the time of the search a proposal for a trial only and had no reported outcomes at this time. AUTHORS' CONCLUSIONS: There is currently no information available from published RCTs on clinically relevant outcome measures with respect to the application of cricoid pressure during RSI in the context of endotracheal intubation. On the basis of the findings of non-RCT literature, however, cricoid pressure may not be necessary to undertake RSI safely, and therefore well-designed and conducted RCTs should nonetheless be encouraged to properly assess the safety and effectiveness of cricoid pressure.

Interventions for reducing wrong-site surgery and invasive clinical procedures.

BACKGROUND: Specific clinical interventions are needed to reduce wrong-site surgery, which is a rare but potentially disastrous clinical error. Risk factors contributing to wrong-site surgery are variable and complex. The introduction of organisational and professional clinical strategies have a role in minimising wrong-site surgery. OBJECTIVES: To evaluate the effectiveness of organisational and professional interventions for reducing wrong-site surgery (including wrong-side, wrong-procedure and wrong-patient surgery), including non-surgical invasive clinical procedures such as regional blocks, dermatological, obstetric and dental procedures and emergency surgical procedures not undertaken within the operating theatre. SEARCH METHODS: For this update, we searched the following electronic databases: the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register (January 2014), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2014), MEDLINE (June 2011 to January 2014), EMBASE (June 2011 to January 2014), CINAHL (June 2011 to January 2014), Dissertations and Theses (June 2011 to January 2014), African Index Medicus, Latin American and Caribbean Health Sciences database, Virtual Health Library, Pan American Health Organization Database and the World Health Organization Library Information System. Database searches were conducted in January 2014. SELECTION CRITERIA: We searched for randomised controlled trials (RCTs), non-randomised controlled trials, controlled before-after studies (CBAs) with at least two intervention and control sites, and interrupted-time-series (ITS) studies where the intervention time was clearly defined and there were at least three data points before and three after the intervention. We included two ITS studies that evaluated the effectiveness of organisational and professional interventions for reducing wrong-site surgery, including wrong-side and wrong-procedure surgery. Participants included all healthcare professionals providing care to surgical patients; studies where patients were involved to avoid the incorrect procedures or studies with interventions addressed to healthcare managers, administrators, stakeholders or health insurers. DATA COLLECTION AND ANALYSIS: Two review authors independently assesses the quality and abstracted data of all eligible studies using a standardised data extraction form, modified from the Cochrane EPOC checklists. We contacted study authors for additional information. MAIN RESULTS: In the initial review, we included one ITS study that evaluated a targeted educational intervention aimed at reducing the incidence of wrong-site tooth extractions. The intervention included examination of previous cases of wrong-site tooth extractions, educational intervention including a presentation of cases of erroneous extractions, explanation of relevant clinical guidelines and feedback by an instructor. Data were reported from all patients on the surveillance system of a University Medical centre in Taiwan with a total of 24,406 tooth extractions before the intervention and 28,084 tooth extractions after the intervention. We re-analysed the data using the Prais-Winsten time series and the change in level for annual number of mishaps was statistically significant at -4.52 (95% confidence interval (CI) -6.83 to -2.217) (standard error (SE) 0.5380). The change in slope was statistically significant at -1.16 (95% CI -2.22 to -0.10) (SE 0.2472; P < 0.05).This update includes an additional study reporting on the incidence of neurological WSS at a university hospital both before and after the Universal Protocol's implementation. A total of 22,743 patients undergoing neurosurgical procedures at the University of Illionois College of Medicine at Peoria, Illinois, United States of America were reported. Of these, 7286 patients were reported before the intervention and 15,456 patients were reported after the intervention. The authors found a significant difference (P < 0.001) in the incidence of WSS between the before period, 1999 to 2004, and the after period, 2005 to 2011.  Similarly, data were re-analysed using Prais-Winsten regression to correct for autocorrelation. As the incidences were reported by year only and the intervention occurred in July 2004, the intervention year 2004 was excluded from the analysis. The change in level at the point the intervention was introduced was not statistically significant at -0.078 percentage points (pp) (95% CI -0.176 pp to 0.02 pp; SE 0.042; P = 0.103). The change in slope was statistically significant at 0.031 (95% CI 0.004 to 0.058; SE 0.012; P < 0.05). AUTHORS' CONCLUSIONS: The findings of this update added one additional ITS study to the previous review which contained one ITS study. The original review suggested that the use of a specific educational intervention in the context of a dental outpatient setting, which targets junior dental staff using a training session that included cases of wrong-site surgery, presentation of clinical guidelines and feedback by an instructor, was associated with a reduction in the incidence of wrong-site tooth extractions. The additional study in this update evaluated the annual incidence rates of wrong-site surgery in a neurosurgical population before and after the implementation of the Universal Protocol. The data suggested a strong downward trend in the incidence of wrong-site surgery prior to the intervention with the incidence rate approaching zero. The effect of the intervention in these studies however remains unclear, as data reflect only two small low-quality studies in very specific population groups.