Effect of non-invasive ventilation after extubation in critically ill patients with obesity in France: a multicentre, unblinded, pragmatic randomised clinical trial.

BACKGROUND: Non-invasive ventilation (NIV) and oxygen therapy (high-flow nasal oxygen [HFNO] or standard oxygen) following extubation have never been compared in critically ill patients with obesity. We aimed to compare NIV (alternating with HFNO or standard oxygen) and oxygen therapy (HFNO or standard oxygen) following extubation of critically ill patients with obesity. METHODS: In this multicentre, parallel group, pragmatic randomised controlled trial, conducted in 39 intensive care units in France, critically ill patients with obesity undergoing extubation were randomly assigned (1:1) to either the NIV group or the oxygen therapy group. Two randomisations were performed: first, randomisation to either NIV or oxygen therapy, and second, randomisation to either HFNO or standard oxygen (also 1:1), which was nested within the first randomisation. Blinding of the randomisation was not possible, but the statistician was masked to group assignment. The primary outcome was treatment failure within 3 days after extubation, a composite of reintubation for mechanical ventilation, switch to the other study treatment, or premature discontinuation of study treatment. The primary outcome was analysed by intention to treat. Effect of medical and surgical status was assessed. The reintubation within 3 days was analysed by intention to treat and after a post-hoc crossover analysis. This study is registered with ClinicalTrials.gov, number NCT04014920. FINDINGS: From Oct 2, 2019, to July 17, 2021, of the 1650 screened patients, 981 were enrolled. Treatment failure occurred in 66 (13·5%) of 490 patients in the NIV group and in 130 (26·5%) of 491 patients in the oxygen-therapy group (relative risk 0·43; 95% CI 0·31-0·60, p<0·0001). Medical or surgical status did not modify the effect of NIV group on the treatment-failure rate. Reintubation within 3 days after extubation was similar in the non-invasive ventilation group and in the oxygen therapy group in the intention-to-treat analysis (48 (10%) of 490 patients and 59 (12%) of 491 patients, p=0·26) and lower in the NIV group than in the oxygen-therapy group in the post-hoc cross-over (51 (9%) of 560 patients and 56 (13%) of 421 patients, p=0·037) analysis. No severe adverse events were reported. INTERPRETATION: Among critically ill adults with obesity undergoing extubation, the use of NIV was effective to reduce treatment-failure within 3 days. Our results are relevant to clinical practice, supporting the use of NIV after extubation of critically ill patients with obesity. However, most of the difference in the primary outcome was due to patients in the oxygen therapy group switching to NIV, and more evidence is needed to conclude that an NIV strategy leads to improved patient-centred outcomes. FUNDING: French Ministry of Health.

Continuous peripheral nerve blocks for analgesia of ventilated critically ill patients with multiple trauma: a prospective randomized study.

BACKGROUND: Sedation of ventilated critically ill trauma patients requires high doses of opioids and hypnotics. We aimed to compare the consumption of opioids and hypnotics, and patient outcomes using sedation with or without continuous regional analgesia (CRA). METHODS: Multiple trauma-ventilated patients were included. The patients were randomized to receive an intravenous analgesia (control group) or an addition of CRA within 24h of admission. A traumatic brain injury (TBI) patients group was analyzed. The primary endpoint was the cumulative consumption of sufentanil at 2 days of admission. Secondary endpoints were cumulative and daily consumption of sufentanil and midazolam, duration of mechanical ventilation, intensive care unit (ICU) stay, and safety of CRA management. RESULTS: Seventy six patients were analyzed: 40 (67.5% males) in the control group and 36 (72% males) in the CRA group, respectively. The median [IQR] Injury Severity Score was 30.5 [23.5-38.5] and 26.0 [22.0-41.0]. The consumption of sufentanil at 48h was 725 [465-960] µg/48h versus 670 [510-940] µg/48h (p = 0.16). Daily consumption did not differ between the groups except on day 1 when consumption of sufentanil was 360 [270-480] µg vs. 480 [352-535] µg (p = 0.03). Consumptions of midazolam did not differ between the groups. No difference was noted between the groups according to the secondary endpoints. CONCLUSIONS: CRA does not decrease significantly sufentanil and midazolam consumption within the first 5 days after ICU admission in multiple trauma-ventilated patients. The use of peripheral nerve blocks in heavily sedated and ventilated trauma patients in the ICU seems safe.

Driving pressure is not predictive of ARDS outcome in chest trauma patients under mechanical ventilation.

BACKGROUND: The relationship between the driving pressure of the respiratory system (ΔPrs) under mechanical ventilation and worse outcome has never been studied specifically in chest trauma patients. The objective of the present study was to assess in cases of chest trauma the relationship between ΔPrs and severity of acute respiratory distress syndrome (ARDS) or death and length of stay. METHODS: A retrospective analysis of severe trauma patients (ISS > 15) with chest injuries admitted to the Trauma Centre from January 2010 to December 2018 was performed. Patients who received mechanical ventilation were included in our analysis. Mechanical ventilation parameters and ΔPrs were recorded during the stay in the intensive care unit. Association of ΔPrs with mortality and outcomes was specifically studied at the onset of ARDS (ΔPrs-ARDS) by receiver operator characteristic curve analysis, Kaplan-Meier curves, and multivariate analysis. RESULTS: Among the 266 chest trauma patients studied, 194 (73%) developed ARDS. ΔPrs was significantly higher in the ARDS group versus in the no ARDS group (11.6 ± 2.4 cm H2O vs. 10.9 ± 1.9 cm H2O, p = 0.04). Among the patients with ARDS, no difference according to the duration of mechanical ventilation was found between the high ΔPrs group (ΔPrs-ARDS > 14 cm H2O) and the low ΔPrs group (ΔPrs-ARDS ≤ 14 cm H2O), (p = 0.75). ΔPrs-ARDS was not independently associated with the duration of mechanical ventilation (hazard ratio [HR], 1.006; 95% CI, 0.95-1.07; p = 0.8) or mortality (HR, 1.07; 95% CI, 0.9-1.28; p = 0.45). High mechanical power (≥ 12 J/min) was associated with a lower time for weaning of mechanical ventilation in Kaplan-Meier curves but not in multivariate analysis (HR, 0.98; 95% CI, 0.94-1.02; p = 0.22). CONCLUSION: A high ΔPrs-ARDS was not significantly associated with an increase in mechanical ventilation duration or mortality risk in ARDS patients with chest trauma in contrast with medical patients.

Pectoral Nerve Blocks for Breast Augmentation Surgery: A Randomized, Double-blind, Dual-centered Controlled Trial.

BACKGROUND: Pectoral nerve blocks have been proposed for analgesia during and after breast cancer surgery, but data are conflicted in aesthetic breast surgery. This trial tested the primary hypothesis that adding a preincisional pectoral nerve block is superior to systemic multimodal analgesic regimen alone for pain control after breast augmentation surgery. A second hypothesis is that rescue opioid consumption would be decreased with a long-lasting effect for both outcomes during the following days. METHODS: Seventy-three adult female patients undergoing aesthetic breast augmentation surgery under general anesthesia were randomly allocated to receive a pectoral nerve block versus no block. Both groups received standard care with protocolized multimodal analgesia alone including systematic acetaminophen and nonsteroidal anti-inflammatory drugs. The primary outcome measure was the maximal numerical rating scale in the first 6 h after extubation. Secondary outcomes included intraoperative remifentanil consumption and from extubation to day 5: maximal numerical rating scale, postoperative cumulative opioid consumption and postoperative opioid side effects, and patient satisfaction recorded at day 5. RESULTS: The maximal numerical rating scale score in the first 6 h was lower in the pectoral nerve block group compared with the control group (3.9 ± 2.5 vs. 5.2 ± 2.2; difference: -1.2 [95% CI, -2.3 to -0.1]; P = 0.036). The pectoral nerve block group had a lower maximal numerical rating scale between days 1 and 5 (2.2 ± 1.9 vs. 3.2 ± 1.7; P = 0.032). The cumulative amount of overall opioids consumption (oral morphine equivalent) was lower for the pectoral nerve block group from hour 6 to day 1 (0.0 [0.0 to 21.0] vs. 21.0 [0.0 to 31.5] mg, P = 0.006) and from days 1 to 5 (0.0 [0.0 to 21.0] vs. 21.0 [0.0 to 51] mg, P = 0.002). CONCLUSIONS: Pectoral nerve block in conjunction with multimodal analgesia provides effective perioperative pain relief after aesthetic breast surgery and is associated with reduced opioid consumption over the first 5 postoperative days.

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.

A combined management with vv-ECMO and independent lung ventilation for asymmetric chest trauma.

Association of independent lung ventilation (ILV) and veno-venous extracorporeal membrane oxygenation (vv-ECMO) may be life-saving therapy in cases of refractory hypoxemia. We report the case of a trauma patient affected by asymmetric hypoxemic lung contusions and massive air leak managed by association of ILV and vv-ECMO. This combined strategy allowed us first to restore physiologic conditions and later to achieve safe thoracic surgery with reduced resection of pulmonary parenchyma. This case highlights the success of a new damage control strategy in extreme cases of persistent air leak with refractory hypoxemia allowing initial vital rescue and a more conservative treatment.

Influence of a temporary stabilization device on respiratory status in patients with severe trauma with a femoral shaft fracture treated by damage control strategy.

BACKGROUND: There are few studies on the safety and respiratory consequences of the use of a skeletal traction (ST) device in the management of femoral shaft fractures with damage control orthopaedics (DCO) strategy, particularly in cases of prolonged use. The aim of this study was to assess the influence of ST compared with an external fixator (EF) on respiratory complications and mechanical ventilation requirements in patients with severe trauma with a femoral shaft fracture managed by DCO strategy. METHODS: We retrospectively reviewed all patients with severe trauma patients with a unilateral femoral shaft fracture admitted to our institution from 2010 to 2015. Patients who did not undergo definitive osteosynthesis during the first 24 h were included and divided into two groups: DCO-ST group and DCO-EF group. In addition to trauma severity, global management of respiratory complications, the incidence of acute respiratory distress syndrome (ARDS) and mechanical ventilation requirements and outcome were compared. RESULTS: Fifty-five patients were managed with DCO strategy (mean Injury Severity Score, 28.4); there were 31 in the DCO-ST group and 24 in the DCO-EF group. No significant difference in terms of the main characteristics, initial severity and associated injuries was observed between the two groups. In contrast, ARDS was found more frequently in the DCO-ST group (81% versus 54%; P = 0.035). Number of ventilation days also tended to be higher in the DCO-ST group (9 days [IQR 3-15 days] versus 7 [IQR 2-16 days]; P = 0.24). No difference was found for mortality and hospitalization duration between the DCO-ST and DCO-EF groups. CONCLUSION: The prolonged use of an ST device in the present cohort was associated with a higher incidence of impaired respiratory function. Therefore, our findings suggest that EF is preferable to ST in the DCO setting for femoral shaft fracture, especially in trauma patients at high risk of developing delayed respiratory failure.

A simple CT score to quantify pelvic and retroperitoneal hematoma associated with pelvic fractures predicts transfusion needs, pelvic hemostatic procedures, and outcome.

BACKGROUND: Pelvic and retroperitoneal hematoma (PRH) in case of pelvic fracture may lead to early hemorrhagic shock. Quantifying PRH remains challenging in clinical practice. The goal of this study was to determine the statistical association between a semi-quantitative scoring system for PRH assessed with computed tomography (CT) and transfusion needs, pelvic hemostatic procedures, and outcome. METHODS: All consecutive severe trauma patients with pelvic ring fracture between 2010 and 2015 were included in this retrospective study. PRH was quantified using semi-quantitative analysis on admission CT scan. The pelvis and retroperitoneal cavity was assessed as 10 compartments. Hematoma was counted as 0 (absent), 1 (minimal or moderate), and 2 (large or bilateral) for each compartment (maximum score of 20). The patients were divided into the following 3 groups: no or minimal PRH (score 0-5), moderate PRH (6-9), and large PRH (10-20). These groups were compared in terms of initial transfusion needs, massive transfusion, hemostatic procedures, and outcome. Logistic regression and receiver operating characteristic (ROC) curves were analyzed. RESULTS: The study included 311 patients with pelvic fracture (mean age 41.9, [SD] 19.9 years; mean ISS 27.4, [SD] 19.4; unstable fractures, 32%; ≥5 units of packed red blood cells, 37%; massive transfusion, 19%; multiple organ failure, 29%; mortality, 13%), divided into no or minimal PRH group (128 (22%)), moderate PRH group (115 (37%)), and large PRH group (68 (22%)). Increasing PRH was found to increase transfusion needs and massive transfusions, with a higher number of pelvic hemostatic procedures, multiple organ failures, increasing need for mechanical ventilation, and prolonged hospitalization; mortality was also increased. These significant statistical associations were confirmed by logistic regression models (odds ratio, 1.2-12.1 for moderate PRH, 3.1-30.2 for large PRH) and ROC curve analysis (area under the ROC curve, 0.59-0.76). CONCLUSION: Semi-quantitative assessment of PRH on admission CT scan allows to predict transfusion needs, hemostatic procedures, and worse outcome of severe trauma patients with pelvic fracture.

Limits of intravascular contrast extravasation on computed tomography scan to define the need for pelvic angioembolization in pelvic blunt trauma: a specific assessment on the risk of false positives.

BACKGROUND: The objective was to assess the predictive performance of different intravascular contrast extravasation (ICE) characteristics for need for pelvic transarterial embolization (TAE) to determine the risk factors of false positives. METHODS: A retrospective study was performed in our trauma center between 2010 and 2015. All severe trauma patients with pelvic fracture were included. Pelvic ICE characteristics on computed tomography (CT) scan were studied: arterial (aSICE), portal surface (pSICE), and extension (exSICE) anatomic relationships. The overall predictive performance of ICE surfaces for pelvic TAE was analyzed using receiver operating characteristic curves. The analysis focused on risk factors for false positives. RESULTS: Among 311 severe trauma patients with pelvic ring fracture (mean age, 42 ± 19 years; mean Injury Severity Score, 27 ± 19), 94 (30%) had at least one pelvic ICE on the initial CT scan. Patients requiring pelvic TAE had significantly larger aSICE and pSICE than others (p = 0.001 and p = 0.035, respectively). The overall ability of ICE surfaces to predict pelvic TAE was modest (aSICE area under the receiver operating characteristic curve, 0.76 [95% confidence interval, 0.64-0.90]; p = 0.011) or nonsignificant (pSICE and exSICE). The high-sensitivity threshold was defined as aSICE 20 mm or more. Using this threshold, 76% of patients were false positives. Risk factors for false positives were admission systolic blood pressure of 90 mm Hg or greater (63% vs 20%; p = 0.03) and low transfusion needs (63% vs 10%; p = 0.009), extravasation in contact with complex bone fracture (78% vs 30%; p = 0.008), or the absence of a direct relationship between extravasation and a large retroperitoneal hematoma (100% vs 38%; p < 0.001). CONCLUSION: A significant pelvic ICE during the arterial phase does not guarantee the need for pelvic TAE. Three quarters of patients with aSICE of 20 mm or more did not need pelvic TAE. Several complementary CT scan criteria will help to identify this risk of false positives to determine adequate hemostatic pelvic procedures. LEVEL OF EVIDENCE: Therapeutic study, level IV.

Regional anesthesia and analgesia after surgery in ICU.

PURPOSE OF REVIEW: The aim is to demonstrate that ICU physicians should play a pivotal role in developing regional anesthesia techniques that are underused in critically ill patients despite the proven facts in perioperative and long-term pain, organ dysfunction, and postsurgery patient health-related quality of life improvement. RECENT FINDINGS: Regional anesthesia and/or analgesia strategies in ICU reduce the surgical and trauma-stress response in surgical patients as well as complications incidence. Recent studies suggested that surgical/trauma ICU patients receive opioid-hypnotics continuous infusions to prevent pain and agitation that could increase the risk of posttraumatic stress disorder and chronic neuropathic pain symptoms, and chronic opioid use. Regional anesthesia use decrease the use of intravenous opioids and the ectopic activity of injured small fibers limiting those phenomena. In Cochrane reviews and prospective randomized trials in major surgery patients, regional anesthesia accelerates the return of the gastrointestinal transit and rehabilitation, decreases postoperative pain and opioids use, reduces ICU/hospital stay, improves pulmonary outcomes, including long period of mechanical ventilation and early extubation, reduces overall adverse cardiac events, and reduces ICU admissions when compared with general anesthesia and intravenous opiates alone. The reduction of long-term mortality has been reported in major vascular or orthopedic surgeries. SUMMARY: Promoting regional anesthesia/analgesia in ICU surgical/trauma patients could undoubtedly limit the risk of complications, ICU/hospital stay, and improve patient's outcome. The use of regional anesthesia permits a high doses opioid use limitation which is mandatory and should be considered as feasible and well tolerated in ICU.