Videolaryngoscopy as a first-intention technique for tracheal intubation in unselected surgical patients: a before and after observational study.

BACKGROUND: Using a Macintosh-style videolaryngoscope as a first-intention device for tracheal intubation of unselected patients in the operating room has not often been studied. We hypothesised that using a Macintosh-style videolaryngoscope as a first-intention device is associated with an increased proportion of easy tracheal intubation. METHODS: In a quality improvement project for airway management aimed at implementing a Macintosh-style videolaryngoscope as a first-intention device, we included all consecutive tracheal intubations in adults from March, 2017 to September, 2020 in two French teaching hospitals. We divided the cohort into three temporal cohorts: the pre-intervention, implementation, and post-intervention periods. The primary outcome was the proportion of easy airway management. The secondary outcomes were the rescue technique, Cormack-Lehane III or IV view, and operator-reported difficulty of intubation. Data from one hospital compliant with the quality improvement project were compared with data from a non-compliant hospital. RESULTS: A total of 26 692 tracheal intubations were performed. Among 11 938 intubations included in the compliant hospital, 5487 were included in the pre-intervention, 1845 in the implementation, and 4606 in the post-intervention periods. In comparison to the pre-intervention period, the proportions of easy tracheal intubation increased from 94.3% (5177 of 5487) to 98.7% (4547 of 4606)) in the post-intervention period (+4.4% [95% confidence interval 3.7-5.1%], P<0.001). In comparison to the pre-intervention period, all secondary outcome proportions were significantly lower in the post-intervention period. No significant changes were noted in the non-compliant hospital between the pre- and post-intervention periods. CONCLUSIONS: Using a Macintosh-style videolaryngoscope as a first-intention device for tracheal intubation in the operating room was associated with a significant increase in the proportion of easy tracheal intubation, compared with use of the standard Macintosh laryngoscope.

Use of pragmatic and explanatory trial designs in acute care research: lessons from COVID-19.

Unique challenges arise when conducting trials to evaluate therapies already in common clinical use, including difficulty enrolling patients owing to widespread open-label use of trial therapies and the need for large sample sizes to detect small but clinically meaningful treatment effects. Despite numerous successes in trials evaluating novel interventions such as vaccines, traditional explanatory trials have struggled to provide definitive answers to time-sensitive questions for acutely ill patients with COVID-19. Pragmatic trials, which can increase efficiency by allowing some or all trial procedures to be embedded into clinical care, are increasingly proposed as a means to evaluate therapies that are in common clinical use. In this Personal View, we use two concurrently conducted COVID-19 trials of hydroxychloroquine (the US ORCHID trial and the UK RECOVERY trial) to contrast the effects of explanatory and pragmatic trial designs on trial conduct, trial results, and the care of patients managed outside of clinical trials. In view of the potential advantages and disadvantages of explanatory and pragmatic trial designs, we make recommendations for their optimal use in the evaluation of therapies in the acute care setting.

Infection control in the intensive care unit: expert consensus statements for SARS-CoV-2 using a Delphi method.

During the current COVID-19 pandemic, health-care workers and uninfected patients in intensive care units (ICUs) are at risk of being infected with SARS-CoV-2 as a result of transmission from infected patients and health-care workers. In the absence of high-quality evidence on the transmission of SARS-CoV-2, clinical practice of infection control and prevention in ICUs varies widely. Using a Delphi process, international experts in intensive care, infectious diseases, and infection control developed consensus statements on infection control for SARS-CoV-2 in an ICU. Consensus was achieved for 31 (94%) of 33 statements, from which 25 clinical practice statements were issued. These statements include guidance on ICU design and engineering, health-care worker safety, visiting policy, personal protective equipment, patients and procedures, disinfection, and sterilisation. Consensus was not reached on optimal return to work criteria for health-care workers who were infected with SARS-CoV-2 or the acceptable disinfection strategy for heat-sensitive instruments used for airway management of patients with SARS-CoV-2 infection. Well designed studies are needed to assess the effects of these practice statements and address the remaining uncertainties.

Multimodal Percutaneous Thermal Ablation of Small Hepatocellular Carcinoma: Predictive Factors of Recurrence and Survival in Western Patients.

BACKGROUND: To identify the predictive factors of recurrence and survival in an unselected population of Western patients who underwent multimodal percutaneous thermal ablation (PTA) for small Hepatocellular Carcinomas (HCCs). METHODS: January 2015-June 2019: data on multimodal PTA for <3 cm HCC were extracted from a prospective database. Local tumor progression (LTP), intrahepatic distant recurrence (IDR), time-to-LTP, time-to-IDR, recurrence-free (RFS) and overall (OS) survival were evaluated. RESULTS: 238 patients underwent 317 PTA sessions to treat 412 HCCs. During follow-up (median: 27.1 months), 47.1% patients had IDR and 18.5% died. LTP occurred after 13.3% of PTA. Tumor size (OR = 1.108, p < 0.001; hazard ratio (HR) = 1.075, p = 0.002) and ultrasound guidance (OR = 0.294, p = 0.017; HR = 0.429, p = 0.009) independently predicted LTP and time-to-LTP, respectively. Alpha fetoprotein (AFP) > 100 ng/mL (OR = 3.027, p = 0.037) and tumor size (OR = 1.06, p = 0.001) independently predicted IDR. Multinodular HCC (HR = 2.67, p < 0.001), treatment-naïve patient (HR = 0.507, p = 0.002) and AFP > 100 ng/mL (HR = 2.767, p = 0.014) independently predicted time-to-IDR. RFS was independently predicted by multinodular HCC (HR = 2.144, p = 0.001), treatment naivety (HR = 0.546, p = 0.004) and AFP > 100 ng/mL (HR = 2.437, p = 0.013). The American Society of Anesthesiologists (ASA) score > 2 (HR = 4.273, p = 0.011), AFP (HR = 1.002, p < 0.001), multinodular HCC (HR = 3.939, p = 0.003) and steatotic HCC (HR = 1.81 × 10-16, p < 0.001) independently predicted OS. CONCLUSIONS: IDR was associated with tumor aggressiveness, suggesting a metastatic mechanism. Besides AFP association with LTP, IDR, RFS and OS, treatment-naïve patients had longer RFS, and multi-nodularity was associated with shorter RFS and OS. Steatotic HCC, identified on pre-treatment MRI, independently predicted longer OS, and needs to be further explored.

Effect of the use of an endotracheal tube and stylet versus an endotracheal tube alone on first-attempt intubation success: a multicentre, randomised clinical trial in 999 patients.

PURPOSE: The effect of the routine use of a stylet during tracheal intubation on first-attempt intubation success is unclear. We hypothesised that the first-attempt intubation success rate would be higher with tracheal tube + stylet than with tracheal tube alone. METHODS: In this multicentre randomised controlled trial, conducted in 32 intensive care units, we randomly assigned patients to tracheal tube + stylet or tracheal tube alone (i.e. without stylet). The primary outcome was the proportion of patients with first-attempt intubation success. The secondary outcome was the proportion of patients with complications related to tracheal intubation. Serious adverse events, i.e., traumatic injuries related to tracheal intubation, were evaluated. RESULTS: A total of 999 patients were included in the modified intention-to-treat analysis: 501 (50%) to tracheal tube + stylet and 498 (50%) to tracheal tube alone. First-attempt intubation success occurred in 392 patients (78.2%) in the tracheal tube + stylet group and in 356 (71.5%) in the tracheal tube alone group (absolute risk difference, 6.7; 95%CI 1.4-12.1; relative risk, 1.10; 95%CI 1.02-1.18; P = 0.01). A total of 194 patients (38.7%) in the tracheal tube + stylet group had complications related to tracheal intubation, as compared with 200 patients (40.2%) in the tracheal tube alone group (absolute risk difference, - 1.5; 95%CI - 7.5 to 4.6; relative risk, 0.96; 95%CI 0.83-1.12; P = 0.64). The incidence of serious adverse events was 4.0% and 3.6%, respectively (absolute risk difference, 0.4; 95%CI, - 2.0 to 2.8; relative risk, 1.10; 95%CI 0.59-2.06. P = 0.76). CONCLUSIONS: Among critically ill adults undergoing tracheal intubation, using a stylet improves first-attempt intubation success.

Impact of early low-calorie low-protein versus standard-calorie standard-protein feeding on outcomes of ventilated adults with shock: design and conduct of a randomised, controlled, multicentre, open-label, parallel-group trial (NUTRIREA-3).

INTRODUCTION: International guidelines include early nutritional support (≤48 hour after admission), 20-25 kcal/kg/day, and 1.2-2 g/kg/day protein at the acute phase of critical illness. Recent data challenge the appropriateness of providing standard amounts of calories and protein during acute critical illness. Restricting calorie and protein intakes seemed beneficial, suggesting a role for metabolic pathways such as autophagy, a potential key mechanism in safeguarding cellular integrity, notably in the muscle, during critical illness. However, the optimal calorie and protein supply at the acute phase of severe critical illness remains unknown. NUTRIREA-3 will be the first trial to compare standard calorie and protein feeding complying with guidelines to low-calorie low-protein feeding. We hypothesised that nutritional support with calorie and protein restriction during acute critical illness decreased day 90 mortality and/or dependency on intensive care unit (ICU) management in mechanically ventilated patients receiving vasoactive amine therapy for shock, compared with standard calorie and protein targets. METHODS AND ANALYSIS: NUTRIREA-3 is a randomised, controlled, multicentre, open-label trial comparing two parallel groups of patients receiving invasive mechanical ventilation and vasoactive amine therapy for shock and given early nutritional support according to one of two strategies: early calorie-protein restriction (6 kcal/kg/day-0.2-0.4 g/kg/day) or standard calorie-protein targets (25 kcal/kg/day, 1.0-1.3 g/kg/day) at the acute phase defined as the first 7 days in the ICU. We will include 3044 patients in 61 French ICUs. Two primary end-points will be evaluated: day 90 mortality and time to ICU discharge readiness. The trial will be considered positive if significant between-group differences are found for one or both alternative primary endpoints. Secondary outcomes include hospital-acquired infections and nutritional, clinical and functional outcomes. ETHICS AND DISSEMINATION: The NUTRIREA-3 study has been approved by the appropriate ethics committee. Patients are included after informed consent. Results will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03573739.

Expert consensus statements for the management of COVID-19-related acute respiratory failure using a Delphi method.

BACKGROUND: Coronavirus disease 2019 (COVID-19) pandemic has caused unprecedented pressure on healthcare system globally. Lack of high-quality evidence on the respiratory management of COVID-19-related acute respiratory failure (C-ARF) has resulted in wide variation in clinical practice. METHODS: Using a Delphi process, an international panel of 39 experts developed clinical practice statements on the respiratory management of C-ARF in areas where evidence is absent or limited. Agreement was defined as achieved when > 70% experts voted for a given option on the Likert scale statement or > 80% voted for a particular option in multiple-choice questions. Stability was assessed between the two concluding rounds for each statement, using the non-parametric Chi-square (χ2) test (p < 0·05 was considered as unstable). RESULTS: Agreement was achieved for 27 (73%) management strategies which were then used to develop expert clinical practice statements. Experts agreed that COVID-19-related acute respiratory distress syndrome (ARDS) is clinically similar to other forms of ARDS. The Delphi process yielded strong suggestions for use of systemic corticosteroids for critical COVID-19; awake self-proning to improve oxygenation and high flow nasal oxygen to potentially reduce tracheal intubation; non-invasive ventilation for patients with mixed hypoxemic-hypercapnic respiratory failure; tracheal intubation for poor mentation, hemodynamic instability or severe hypoxemia; closed suction systems; lung protective ventilation; prone ventilation (for 16-24 h per day) to improve oxygenation; neuromuscular blocking agents for patient-ventilator dyssynchrony; avoiding delay in extubation for the risk of reintubation; and similar timing of tracheostomy as in non-COVID-19 patients. There was no agreement on positive end expiratory pressure titration or the choice of personal protective equipment. CONCLUSION: Using a Delphi method, an agreement among experts was reached for 27 statements from which 20 expert clinical practice statements were derived on the respiratory management of C-ARF, addressing important decisions for patient management in areas where evidence is either absent or limited. TRIAL REGISTRATION: The study was registered with Clinical trials.gov Identifier: NCT04534569.

A national healthcare response to intensive care bed requirements during the COVID-19 outbreak in France.

BACKGROUND: Whereas 5415 Intensive Care Unit (ICU) beds were initially available, 7148 COVID-19 patients were hospitalised in the ICU at the peak of the outbreak. The present study reports how the French Health Care system created temporary ICU beds to avoid being overwhelmed. METHODS: All French ICUs were contacted for answering a questionnaire focusing on the available beds and health care providers before and during the outbreak. RESULTS: Among 336 institutions with ICUs before the outbreak, 315 (94%) participated, covering 5054/5531 (91%) ICU beds. During the outbreak, 4806 new ICU beds (+95% increase) were created from Acute Care Unit (ACU, 2283), Post Anaesthetic Care Unit and Operating Theatre (PACU & OT, 1522), other units (374) or real build-up of new ICU beds (627), respectively. At the peak of the outbreak, 9860, 1982 and 3089 ICU, ACU and PACU beds were made available. Before the outbreak, 3548 physicians (2224 critical care anaesthesiologists, 898 intensivists and 275 from other specialties, 151 paediatrics), 1785 residents, 11,023 nurses and 6763 nursing auxiliaries worked in established ICUs. During the outbreak, 2524 physicians, 715 residents, 7722 nurses and 3043 nursing auxiliaries supplemented the usual staff in all ICUs. A total number of 3212 new ventilators were added to the 5997 initially available in ICU. CONCLUSION: During the COVID-19 outbreak, the French Health Care system created 4806 ICU beds (+95% increase from baseline), essentially by transforming beds from ACUs and PACUs. Collaboration between intensivists, critical care anaesthesiologists, emergency physicians as well as the mobilisation of nursing staff were primordial in this context.

Analgesia and sedation in patients with ARDS.

Acute Respiratory Distress Syndrome (ARDS) is one of the most demanding conditions in an Intensive Care Unit (ICU). Management of analgesia and sedation in ARDS is particularly challenging. An expert panel was convened to produce a "state-of-the-art" article to support clinicians in the optimal management of analgesia/sedation in mechanically ventilated adults with ARDS, including those with COVID-19. Current ICU analgesia/sedation guidelines promote analgesia first and minimization of sedation, wakefulness, delirium prevention and early rehabilitation to facilitate ventilator and ICU liberation. However, these strategies cannot always be applied to patients with ARDS who sometimes require deep sedation and/or paralysis. Patients with severe ARDS may be under-represented in analgesia/sedation studies and currently recommended strategies may not be feasible. With lightened sedation, distress-related symptoms (e.g., pain and discomfort, anxiety, dyspnea) and patient-ventilator asynchrony should be systematically assessed and managed through interprofessional collaboration, prioritizing analgesia and anxiolysis. Adaptation of ventilator settings (e.g., use of a pressure-set mode, spontaneous breathing, sensitive inspiratory trigger) should be systematically considered before additional medications are administered. Managing the mechanical ventilator is of paramount importance to avoid the unnecessary use of deep sedation and/or paralysis. Therefore, applying an "ABCDEF-R" bundle (R = Respiratory-drive-control) may be beneficial in ARDS patients. Further studies are needed, especially regarding the use and long-term effects of fast-offset drugs (e.g., remifentanil, volatile anesthetics) and the electrophysiological assessment of analgesia/sedation (e.g., electroencephalogram devices, heart-rate variability, and video pupillometry). This review is particularly relevant during the COVID-19 pandemic given drug shortages and limited ICU-bed capacity.

Prone position in ARDS patients: why, when, how and for whom.

In ARDS patients, the change from supine to prone position generates a more even distribution of the gas-tissue ratios along the dependent-nondependent axis and a more homogeneous distribution of lung stress and strain. The change to prone position is generally accompanied by a marked improvement in arterial blood gases, which is mainly due to a better overall ventilation/perfusion matching. Improvement in oxygenation and reduction in mortality are the main reasons to implement prone position in patients with ARDS. The main reason explaining a decreased mortality is less overdistension in non-dependent lung regions and less cyclical opening and closing in dependent lung regions. The only absolute contraindication for implementing prone position is an unstable spinal fracture. The maneuver to change from supine to prone and vice versa requires a skilled team of 4-5 caregivers. The most frequent adverse events are pressure sores and facial edema. Recently, the use of prone position has been extended to non-intubated spontaneously breathing patients affected with COVID-19 ARDS. The effects of this intervention on outcomes are still uncertain.