Long term outcomes following percutaneous dilatational tracheostomy in the critically ill

Background: Percutaneous procedures are now the predominant tracheostomy technique within the critical care setting. Complication rates for various techniques appear to be equivalent to those achieved with surgical tracheostomy. There is a paucity of data when comparing percutaneous procedures, particularly when considering late complications (tracheo-innominate artery fistulae (TIF), tracheooesophageal fistulae (TOF) and tracheal stenosis (TS). Given the severity of illness and associated mortality in many of these patients the incidence of these complications remains difficult to define. Confounding factors present in survivors of critical illness may present difficulties in diagnosis such that underlying tracheal pathology may go undiagnosed. Aims: To determine: The incidence of common early and late complications of percutaneous dilatational tracheostomy (PDT) in relation to surgical tracheostomy (ST). The role of peri-operative events that may contribute to the aetiology of late complications of TS, TIF and TOF. The incidence of early and late complications in relation to percutaneous tracheostomy to define the safest percutaneous technique. The utility of adjunctive techniques (bronchoscopy & ultrasound scanning) in reducing complications of PDT. The prevalence of sub-clinical TS following PDT using the single tapered dilator technique (STD). Aetiological factors for sub-clinical TS. Whether sub-clinical TS may present atypically in critical illness survivors. Methods: We have conducted a systematic review of all prospective studies reporting late complications after tracheostomy performed in the critically ill. We have also extracted data to assess the role of peri-operative events and monitoring in causing or preventing late complications. We have undertaken an eleven-year review of all PDTs performed within our unit to define the incidence of complications arising within our own population. Finally, a prospective study to identify the prevalence of sub-clinical TS and identify atypical presenting features in survivors of critical illness has been performed. Results: All surgical and percutaneous techniques are broadly similar in terms of early and late complications. There is a higher incidence of wound infection when comparing ST to the multiple dilator PDT. There are few studies assessing late complications between percutaneous techniques. The TS rate varies from 2.8 to 0.6% for ST and the STD technique respectively. Due to limited data we were unable to identify peri-operative events that may lead to late complications. There is a very low rate of complications attributed to the STD technique with only 9 significant late adverse events. The rate of sub-clinical TS is low with doubtful clinical significance. Conclusions: We have not found a significant difference in the incidence of TS between PDT and ST. Our pooled proportions meta-analysis may indicate a tendency toward a higher rate of stenosis for ST. The reported complication rates presented within our cohort study may indicate that the STD PDT is one of the safer techniques available. The rate of sub-clinical stenoses following STD PDT is low and of doubtful clinical significance. Further work is required to define the role for percutaneous tracheostomy outside the critical care setting and to gather qualitative data to assess the patient’s perception of tracheostomy in the critical care setting

Hyperoxemia and excess oxygen use in early acute respiratory distress syndrome : Insights from the LUNG SAFE study

Publisher Copyright: © 2020 The Author(s). Copyright: Copyright 2020 Elsevier B.V., All rights reserved.Background: Concerns exist regarding the prevalence and impact of unnecessary oxygen use in patients with acute respiratory distress syndrome (ARDS). We examined this issue in patients with ARDS enrolled in the Large observational study to UNderstand the Global impact of Severe Acute respiratory FailurE (LUNG SAFE) study. Methods: In this secondary analysis of the LUNG SAFE study, we wished to determine the prevalence and the outcomes associated with hyperoxemia on day 1, sustained hyperoxemia, and excessive oxygen use in patients with early ARDS. Patients who fulfilled criteria of ARDS on day 1 and day 2 of acute hypoxemic respiratory failure were categorized based on the presence of hyperoxemia (PaO2 > 100 mmHg) on day 1, sustained (i.e., present on day 1 and day 2) hyperoxemia, or excessive oxygen use (FIO2 ≥ 0.60 during hyperoxemia). Results: Of 2005 patients that met the inclusion criteria, 131 (6.5%) were hypoxemic (PaO2 < 55 mmHg), 607 (30%) had hyperoxemia on day 1, and 250 (12%) had sustained hyperoxemia. Excess FIO2 use occurred in 400 (66%) out of 607 patients with hyperoxemia. Excess FIO2 use decreased from day 1 to day 2 of ARDS, with most hyperoxemic patients on day 2 receiving relatively low FIO2. Multivariate analyses found no independent relationship between day 1 hyperoxemia, sustained hyperoxemia, or excess FIO2 use and adverse clinical outcomes. Mortality was 42% in patients with excess FIO2 use, compared to 39% in a propensity-matched sample of normoxemic (PaO2 55-100 mmHg) patients (P = 0.47). Conclusions: Hyperoxemia and excess oxygen use are both prevalent in early ARDS but are most often non-sustained. No relationship was found between hyperoxemia or excessive oxygen use and patient outcome in this cohort. Trial registration: LUNG-SAFE is registered with ClinicalTrials.gov, NCT02010073publishersversionPeer reviewe

The Sabadell score is an independent predictor of five-year outcome after critical care discharge

Background: Critical care survivors frequently suffer persistent morbidity and increased risk of mortality compared to the general population. However, there are no standardised tools to identify at-risk patients to target potential interventions. Our aim was to establish whether the “Sabadell score”, a simple tool applied upon critical care discharge, is an independent predictor of five-year mortality. Methods: Prospective observational cohort study of adults admitted to a mixed critical care unit at Aintree University Hospital NHS Foundation Trust, Liverpool, United Kingdom. Sabadell score applied to all patients from September 2011 to December 2017. Primary outcome: five-year mortality assessed using a multivariable flexible parametric survival analysis adjusted for demographics, and clinically relevant covariates. Primary outcome: Adults discharged alive following critical care admission. Results: There were 5954 patients with a minimum of 18 months follow-up. Mean age was 59.5 (SD±17) and 57.1% were male. Patients were categorised into Sabadell scores, zero (38.4%), one (47.9%), two (10.5%) and three (3.1%). Adjusted hazard ratios for mortality were 2.09 (C.I. 1.85–2.36), 3.95 (C.I. 3.39–4.60) and 21.04 (C.I. 17.24–25.68) respectively. Sabadell score three predicted 99.9%, 99.5%, 98.5% and 87.4% mortality at five years for patients ³80 (aHR 3.37), 60-79 (aHR 2.52), 40-59 (aHR 2.03) and 16-39 respectively. A Sabadell score of two predicted 71.0%, 52.7%, 44.8% and 23.7% mortality at five years for these age categories.Conclusions : Sabadell score is an independent predictor of five-year survival after critical care discharge. These findings could be used to guide provision of increased support for patients after critical care discharge and/or informed discussions with patients and relatives about dying to ascertain their future wishes

Long-Term Outcome Following Tracheostomy in Critical Care: A Systematic Review

Objectives: The prevalence and impact of longer-term outcomes following percutaneous tracheostomy, particularly tracheal stenosis, are unclear. Previous meta-analyses addressing this problem have been confounded by the low prevalence of tracheal stenosis and a limited number of studies. Design: Embase, PubMed-Medline, and the Cochrane Central Register of Clinical Trials were searched to identify all prospective studies of tracheostomy insertion in the critically ill. To reflect contemporary practice, the search was limited to studies published from 2000 onward. We scrutinized the bibliographies of returned studies for additional articles. Meta-analyses were undertaken to estimate the pooled risk difference of tracheal stenosis, bleeding, and wound infection comparing different techniques. Measurements and Main Results: We identified a total of 463 studies, 29 (5,473 patients) of which met the inclusion criteria. Nine were randomized controlled trials, six were nonrandomized comparative studies, and 14 were single-arm cohort studies. Risk of wound infection was greater for the surgical tracheostomy than for the Ciaglia multiple dilator technique, pooled risk difference 0.12 (95% CI, 0.02–0.23). We did not identify significant risk differences in other meta-analyses. Pooling across all studies according to the random-effects proportion meta-analysis suggests a higher prevalence of tracheal stenosis, wound infection, and major bleeding for surgical tracheostomies. Conclusions: Considering comparative data, there was no significant difference in the prevalence of tracheal stenosis or major bleeding between percutaneous and surgical tracheostomy. In relation to wound infection, we have found a reduction associated with the original Ciaglia technique when compared with that with the surgical tracheostomy. Considering all published data reporting long-term outcomes pooled proportion meta-analysis indicates a trend toward a higher rate of tracheal stenosis and an increased risk of major bleeding and wound infection for surgical tracheostomies. This finding may be biased as a result of targeted patient selection, and further, high-quality long-term comparative data are needed to confirm these findings

Immunocompromised patients with acute respiratory distress syndrome : Secondary analysis of the LUNG SAFE database

The aim of this study was to describe data on epidemiology, ventilatory management, and outcome of acute respiratory distress syndrome (ARDS) in immunocompromised patients. Methods: We performed a post hoc analysis on the cohort of immunocompromised patients enrolled in the Large Observational Study to Understand the Global Impact of Severe Acute Respiratory Failure (LUNG SAFE) study. The LUNG SAFE study was an international, prospective study including hypoxemic patients in 459 ICUs from 50 countries across 5 continents. Results: Of 2813 patients with ARDS, 584 (20.8%) were immunocompromised, 38.9% of whom had an unspecified cause. Pneumonia, nonpulmonary sepsis, and noncardiogenic shock were their most common risk factors for ARDS. Hospital mortality was higher in immunocompromised than in immunocompetent patients (52.4% vs 36.2%; p < 0.0001), despite similar severity of ARDS. Decisions regarding limiting life-sustaining measures were significantly more frequent in immunocompromised patients (27.1% vs 18.6%; p < 0.0001). Use of noninvasive ventilation (NIV) as first-line treatment was higher in immunocompromised patients (20.9% vs 15.9%; p = 0.0048), and immunodeficiency remained independently associated with the use of NIV after adjustment for confounders. Forty-eight percent of the patients treated with NIV were intubated, and their mortality was not different from that of the patients invasively ventilated ab initio. Conclusions: Immunosuppression is frequent in patients with ARDS, and infections are the main risk factors for ARDS in these immunocompromised patients. Their management differs from that of immunocompetent patients, particularly the greater use of NIV as first-line ventilation strategy. Compared with immunocompetent subjects, they have higher mortality regardless of ARDS severity as well as a higher frequency of limitation of life-sustaining measures. Nonetheless, nearly half of these patients survive to hospital discharge. Trial registration: ClinicalTrials.gov, NCT02010073. Registered on 12 December 2013

Immunocompromised patients with acute respiratory distress syndrome: Secondary analysis of the LUNG SAFE database

Background: The aim of this study was to describe data on epidemiology, ventilatory management, and outcome of acute respiratory distress syndrome (ARDS) in immunocompromised patients. Methods: We performed a post hoc analysis on the cohort of immunocompromised patients enrolled in the Large Observational Study to Understand the Global Impact of Severe Acute Respiratory Failure (LUNG SAFE) study. The LUNG SAFE study was an international, prospective study including hypoxemic patients in 459 ICUs from 50 countries across 5 continents. Results: Of 2813 patients with ARDS, 584 (20.8%) were immunocompromised, 38.9% of whom had an unspecified cause. Pneumonia, nonpulmonary sepsis, and noncardiogenic shock were their most common risk factors for ARDS. Hospital mortality was higher in immunocompromised than in immunocompetent patients (52.4% vs 36.2%; p &lt; 0.0001), despite similar severity of ARDS. Decisions regarding limiting life-sustaining measures were significantly more frequent in immunocompromised patients (27.1% vs 18.6%; p &lt; 0.0001). Use of noninvasive ventilation (NIV) as first-line treatment was higher in immunocompromised patients (20.9% vs 15.9%; p = 0.0048), and immunodeficiency remained independently associated with the use of NIV after adjustment for confounders. Forty-eight percent of the patients treated with NIV were intubated, and their mortality was not different from that of the patients invasively ventilated ab initio. Conclusions: Immunosuppression is frequent in patients with ARDS, and infections are the main risk factors for ARDS in these immunocompromised patients. Their management differs from that of immunocompetent patients, particularly the greater use of NIV as first-line ventilation strategy. Compared with immunocompetent subjects, they have higher mortality regardless of ARDS severity as well as a higher frequency of limitation of life-sustaining measures. Nonetheless, nearly half of these patients survive to hospital discharge. Trial registration: ClinicalTrials.gov, NCT02010073. Registered on 12 December 2013

Effect of lower tidal volume ventilation facilitated by extracorporeal carbon dioxide removal vs standard care ventilation on 90-day mortality in patients with acute hypoxemic respiratory failure

Importance In patients who require mechanical ventilation for acute hypoxemic respiratory failure, further reduction in tidal volumes, compared with conventional low tidal volume ventilation, may improve outcomes. Objective To determine whether lower tidal volume mechanical ventilation using extracorporeal carbon dioxide removal improves outcomes in patients with acute hypoxemic respiratory failure. Design, Setting, and Participants This multicenter, randomized, allocation-concealed, open-label, pragmatic clinical trial enrolled 412 adult patients receiving mechanical ventilation for acute hypoxemic respiratory failure, of a planned sample size of 1120, between May 2016 and December 2019 from 51 intensive care units in the UK. Follow-up ended on March 11, 2020. Interventions Participants were randomized to receive lower tidal volume ventilation facilitated by extracorporeal carbon dioxide removal for at least 48 hours (n = 202) or standard care with conventional low tidal volume ventilation (n = 210). Main Outcomes and Measures The primary outcome was all-cause mortality 90 days after randomization. Prespecified secondary outcomes included ventilator-free days at day 28 and adverse event rates. Results Among 412 patients who were randomized (mean age, 59 years; 143 [35%] women), 405 (98%) completed the trial. The trial was stopped early because of futility and feasibility following recommendations from the data monitoring and ethics committee. The 90-day mortality rate was 41.5% in the lower tidal volume ventilation with extracorporeal carbon dioxide removal group vs 39.5% in the standard care group (risk ratio, 1.05 [95% CI, 0.83-1.33]; difference, 2.0% [95% CI, −7.6% to 11.5%]; P = .68). There were significantly fewer mean ventilator-free days in the extracorporeal carbon dioxide removal group compared with the standard care group (7.1 [95% CI, 5.9-8.3] vs 9.2 [95% CI, 7.9-10.4] days; mean difference, −2.1 [95% CI, −3.8 to −0.3]; P = .02). Serious adverse events were reported for 62 patients (31%) in the extracorporeal carbon dioxide removal group and 18 (9%) in the standard care group, including intracranial hemorrhage in 9 patients (4.5%) vs 0 (0%) and bleeding at other sites in 6 (3.0%) vs 1 (0.5%) in the extracorporeal carbon dioxide removal group vs the control group. Overall, 21 patients experienced 22 serious adverse events related to the study device. Conclusions and Relevance Among patients with acute hypoxemic respiratory failure, the use of extracorporeal carbon dioxide removal to facilitate lower tidal volume mechanical ventilation, compared with conventional low tidal volume mechanical ventilation, did not significantly reduce 90-day mortality. However, due to early termination, the study may have been underpowered to detect a clinically important difference

The impact of frailty on ICU and 30-day mortality and the level of care in very elderly patients (≥ 80 years)

Purpose: Very old critical ill patients are a rapid expanding group in the ICU. Indications for admission, triage criteria and level of care are frequently discussed for such patients. However, most relevant outcome studies in this group frequently find an increased mortality and a reduced quality of life in survivors. The main objective was to study the impact of frailty compared with other variables with regards to short-term outcome in the very old ICU population. Methods: A transnational prospective cohort study from October 2016 to May 2017 with 30 days follow-up was set up by the European Society of Intensive Care Medicine. In total 311 ICUs from 21 European countries participated. The ICUs included the first consecutive 20 very old (≥ 80 years) patients admitted to the ICU within a 3-month inclusion period. Frailty, SOFA score and therapeutic procedures were registered, in addition to limitations of care. For measurement of frailty the Clinical Frailty Scale was used at ICU admission. The main outcomes were ICU and 30-day mortality and survival at 30 days. Results: A total of 5021 patients with a median age of 84 years (IQR 81–86 years) were included in the final analysis, 2404 (47.9%) were women. Admission was classified as acute in 4215 (83.9%) of the patients. Overall ICU and 30-day mortality rates were 22.1% and 32.6%. During ICU stay 23.8% of the patients did not receive specific ICU procedures: ventilation, vasoactive drugs or renal replacement therapy. Frailty (values ≥ 5) was found in 43.1% and was independently related to 30-day survival (HR 1.54; 95% CI 1.38–1.73) for frail versus non-frail. Conclusions: Among very old patients (≥ 80 years) admitted to the ICU, the consecutive classes in Clinical Frailty Scale were inversely associated with short-term survival. The scale had a very low number of missing data. These findings provide support to add frailty to the clinical assessment in this patient group. Trial registration: ClinicalTrials.gov (ID: NCT03134807)