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Objective: To compare reintubation rates after planned extubation and unplanned extubation (UE) in patients in neonatal intensive care units (NICUs), to analyse risk factors for reintubation after UE and to compare outcomes in patients with and without UE., Design: Prospective, observational study nested in a randomised controlled trial (SEPREVEN/Study on Epidemiology and PRevention of adverse EVEnts in Neonates). Outcomes were expected to be independent of the intervention tested., Setting: 12 NICUs in France with a 20-month follow-up, starting November 2015., Patients: n=2280 patients with a NICU stay >2 days, postmenstrual age ≤42 weeks on admission., Interventions/exposure: Characteristics of UE (context, timing, sedative administration in the preceding 6 hours, weaning from ventilation at time of UE) and patients., Main Outcome Measures: Healthcare professional-reported UE rates, reintubation/timing after extubation, duration of mechanical ventilation, mortality and bronchopulmonary dysplasia (BPD)., Results: There were 162 episodes of UE (139 patients, median gestational age (IQR) 27.3 (25.6-31.7) weeks). Cumulative reintubation rates within 24 hours and 7 days of UE were, respectively, 50.0% and 57.5%, compared with 5.5% and 12.3% after a planned extubation. Independent risk factors for reintubation within 7 days included absence of weaning at the time of UE (HR, 95% CI) and sedatives in the preceding 6 hours (HR 1.93, 95% CI 1.04 to 3.60). Mortality at discharge did not differ between patients with planned extubation or UE. UE was associated with a higher risk of BPD., Conclusion: In the SEPREVEN trial, reintubation followed UE in 58% of the cases, compared with 12% after planned extubation., Trial Registration Number: NCT02598609., Competing Interests: Competing interests: TD, FC, HY, EA, RL and LS have no conflict of interest to declare. MT declared consulting fees from Pfizer and payments for honoraria and lectures from Gennisium Pharma and Pfizer. LC declares honoraria from Chiesi for lectures unrelated to this topic. CJ declares payment or honoraria for lectures or presentations for Nestlé and Menarini unrelated to this topic. XD declares personal payment for lectures, presentations, speakers bureaus, manuscript writing or educational events from AstraZeneca and from Gennisium Pharma, and support for attending meetings and/or travel (launch congress organisers, launch meeting 2023, European Society for Pediatric Research, Abbott). HY declares support for attending meetings and/or travel from Duomed, Guigoz and Chiesi., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Diaphragm dysfunction is highly prevalent in mechanically ventilated patients. Recent work showed that changes in diaphragm shear modulus (ΔSMdi) assessed using ultrasound shear wave elastography (SWE) are strongly related to changes in Pdi (ΔPdi) in healthy subjects. The aims of this study were to investigate the relationship between ΔSMdi and ΔPdi in mechanically ventilated patients, and whether ΔSMdi is responsive to change in respiratory load when varying the ventilator settings., Methods: A prospective, monocentric study was conducted in a 15-bed ICU. Patients were included if they met the readiness-to-wean criteria. Pdi was continuously monitored using a double-balloon feeding catheter orally introduced. The zone of apposition of the right hemidiaphragm was imaged using a linear transducer (SL10-2, Aixplorer, Supersonic Imagine, France). Ultrasound recordings were performed under various pressure support settings and during a spontaneous breathing trial (SBT). A breath-by-breath analysis was performed, allowing the direct comparison between ΔPdi and ΔSMdi. Pearson's correlation coefficients (r) were used to investigate within-individual relationships between variables, and repeated measure correlations (R) were used for determining overall relationships between variables. Linear mixed models were used to compare breathing indices across the conditions of ventilation., Results: Thirty patients were included and 930 respiratory cycles were analyzed. Twenty-five were considered for the analysis. A significant correlation was found between ΔPdi and ΔSMdi (R = 0.45, 95% CIs [0.35 0.54], p < 0.001). Individual correlation displays a significant correlation in 8 patients out of 25 (r = 0.55-0.86, all p < 0.05, versus r = - 0.43-0.52, all p > 0.06). Changing the condition of ventilation similarly affected ΔPdi and ΔSMdi. Patients in which ΔPdi-ΔSMdi correlation was non-significant had a faster respiratory rate as compared to that of patient with a significant ΔPdi-ΔSMdi relationship (median (Q1-Q3), 25 (18-33) vs. 21 (15-26) breaths.min -1 , respectively)., Conclusions: We demonstrate that ultrasound SWE may be a promising surrogate to Pdi in mechanically ventilated patients. Respiratory rate appears to negatively impact SMdi measurement. Technological developments are needed to generalize this method in tachypneic patients., Trial Registration: NCT03832231 .

Background: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has been increasingly used over the last decade in patients with refractory cardiogenic shock. ECMO weaning can, however, be challenging and lead to circulatory failure and death. Recent data suggest a potential benefit of levosimendan for ECMO weaning. We sought to further investigate whether the use of levosimendan could decrease the rate of ECMO weaning failure in adult patients with refractory cardiogenic shock., Methods: We performed an observational single-center cohort study. All patients undergoing VA-ECMO from January 2012 to December 2018 were eligible and divided into two groups: group levosimendan and group control (without levosimendan). The primary endpoint was VA-ECMO weaning failure defined as death during VA-ECMO treatment or within 24 h after VA-ECMO removal. Secondary outcomes were mortality at day 28 and at 6 months. The two groups were compared after propensity score matching. P < 0.05 was considered statistically significant., Results: Two hundred patients were analyzed (levosimendan group: n = 53 and control group: n = 147). No significant difference was found between groups on baseline characteristics except for ECMO duration, which was longer in the levosimendan group (10.6 ± 4.8 vs. 6.5 ± 4.7 days, p < 0.001). Levosimendan administration started 6.6 ± 5.4 days on average following ECMO implantation. After matching of 48 levosimendan patients to 78 control patients, the duration of ECMO was similar in both groups. The rate of weaning failure was 29.1% and 35.4% in levosimendan and control groups, respectively (OR: 0.69, 95%CI: 0.25-1.88). No significant difference was found between groups for all secondary outcomes., Conclusion: Levosimendan did not improve the rate of successful VA-ECMO weaning in patients with refractory cardiogenic shock., Trial Registration: ClinicalTrials.gov, NCT04323709 .

Rationale: Detecting weaning-induced pulmonary oedema (WIPO) is important because its treatment might prompt extubation. For this purpose, lung ultrasound might be an attractive tool, since it demonstrates pulmonary oedema through the appearance of B-lines., Objectives: To test the ideal profile (increase in the number of B-lines) for diagnosing WIPO., Methods: Before and at the end of 62 spontaneous breathing trials (SBT) performed in 42 patients, we prospectively assessed lung ultrasound on four anterior chest wall points. B-lines were counted before and at the end of SBT. We looked for the threshold of B-line increase (Delta-B-lines) that provided the best diagnostic accuracy, compared to the reference diagnosis of WIPO established by experts blinded to lung ultrasound., Results: SBT failed in 33 cases. WIPO occurred in 17 cases and all failed. The best diagnostic accuracy was reached with a Delta-B-lines ≥ 6. Among WIPO, the number of B-lines increased by ≥ 6 in 15 cases (including 13 cases with an increase of ≥ 8 B-lines). Among the 16 cases with SBT failure but without WIPO, the Delta-B-lines was ≥ 6 in two cases. Among the 33 cases with SBT failure, this profile diagnosed WIPO with a sensitivity of 88% (64-98) and a specificity of 88% (62-98) [area under the receiver operating characteristic curve 0.91 (0.75-0.98)]. Among the 29 cases with SBT success, a Delta-B-lines ≥ 6 occurred in two cases., Conclusions: This study suggests that a Delta-B-lines ≥  6 on four anterior points allows the diagnosis of WIPO with the best accuracy. This should be confirmed in larger populations.

Background: Mechanical ventilation (MV) is a life-saving technology that restores or assists breathing. Like any treatment, MV has side effects. In some patients it can cause diaphragmatic atrophy, injury, and dysfunction (ventilator-induced diaphragmatic dysfunction, VIDD). Accumulating evidence suggests that VIDD makes weaning from MV difficult, which involves increased morbidity and mortality., Methods and Analysis: This paper describes the protocol of a randomized, controlled, open-label, multicenter trial that is designed to investigate the safety and effectiveness of a novel therapy, temporary transvenous diaphragm pacing (TTVDP), to improve weaning from MV in up to 88 mechanically ventilated adult patients who have failed at least two spontaneous breathing trials over at least 7 days. Patients will be randomized (1:1) to TTVDP (treatment) or standard of care (control) groups. The primary efficacy endpoint is time to successful extubation with no reintubation within 48 h. Secondary endpoints include maximal inspiratory pressure and ultrasound-measured changes in diaphragm thickness and diaphragm thickening fraction over time. In addition, observational data will be collected and analyzed, including 30-day mortality and time to discharge from the intensive care unit and from the hospital. The hypothesis to be tested postulates that more TTVDP patients than control patients will be successfully weaned from MV within the 30 days following randomization., Discussion: This study is the first large-scale clinical trial of a novel technology (TTVDP) aimed at accelerating difficult weaning from MV. The technology tested provides the first therapy directed specifically at VIDD, an important cause of delayed weaning from MV. Its results will help delineate the place of this therapeutic approach in clinical practice and help design future studies aimed at defining the indications and benefits of TTVDP., Trial Registration: ClinicalTrials.gov, NCT03096639 . Registered on 30 March 2017.

Background: Prolonged weaning is a major issue in intensive care patients and tracheostomy is one of the last resort options. Optimized patient-ventilator interaction is essential to weaning. The purpose of this study was to compare patient-ventilator synchrony between pressure support ventilation (PSV) and neurally adjusted ventilatory assist (NAVA) in a selected population of tracheostomised patients., Methods: We performed a prospective, sequential, non-randomized and single-centre study. Two recording periods of 60 min of airway pressure, flow, and electrical activity of the diaphragm during PSV and NAVA were recorded in a random assignment and eight periods of 1 min were analysed for each mode. We searched for macro-asynchronies (ineffective, double, and auto-triggering) and micro-asynchronies (inspiratory trigger delay, premature, and late cycling). The number and type of asynchrony events per minute and asynchrony index (AI) were determined. The two respiratory phases were compared using the non-parametric Wilcoxon test after testing the equality of the two variances (F-Test)., Results: Among the 61 patients analysed, the total AI was lower in NAVA than in PSV mode: 2.1% vs 14% (p < 0.0001). This was mainly due to a decrease in the micro-asynchronies index: 0.35% vs 9.8% (p < 0.0001). The occurrence of macro-asynchronies was similar in both ventilator modes except for double triggering, which increased in NAVA. The tidal volume (ml/kg) was lower in NAVA than in PSV (5.8 vs 6.2, p < 0.001), and the respiratory rate was higher in NAVA than in PSV (28 vs 26, p < 0.05)., Conclusion: NAVA appears to be a promising ventilator mode in tracheotomised patients, especially for those requiring prolonged weaning due to the decrease in asynchronies.

Rationale: The weaning process concerns all patients receiving mechanical ventilation. A previous classification into simple, prolonged, and difficult weaning ignored weaning failure and presupposed the use of spontaneous breathing trials., Objectives: To describe the weaning process, defined as starting with any attempt at separation from mechanical ventilation and its prognosis, according to a new operational classification working for all patients under ventilation., Methods: This was a multinational prospective multicenter observational study over 3 months of all patients receiving mechanical ventilation in 36 intensive care units, with daily collection of ventilation and weaning modalities. Pragmatic definitions of separation attempt and weaning success allowed us to allocate patients in four groups., Measurements and Main Results: A total of 2,729 patients were enrolled. Although half of them could not be classified using the previous definition, 99% entered the groups on the basis of our new definition as follows: 24% never started a weaning process, 57% had a weaning process of less than 24 hours (group 1), 10% had a difficult weaning of more than 1 day and less than 1 week (group 2), and 9% had a prolonged weaning duration of 1 week or more (group 3). Duration of ventilation, intensive care unit stay, and mortality (6, 17, and 29% for the three groups, respectively) all significantly increased from one group to the next. The unadjusted risk of dying was 19% after the first separation attempt and increased to 37% after 10 days., Conclusions: A new classification allows us to categorize all weaning situations. Every additional day without a weaning success after the first separation attempt increases the risk of dying.

Purpose: Intrapulmonary percussive ventilation (IPV) is a high-frequency ventilation modality that can be superimposed on spontaneous breathing. IPV may diminish respiratory muscle loading and help to mobilize secretions. The aim of this prospective study was to assess the short-term effects of IPV in patients at high risk for extubation failure who were receiving preventive non-invasive ventilation (NIV) after extubation., Methods: Respiratory rate, work of breathing, and gas exchange were evaluated in 17 extubated patients during 20 min of IPV and 20 min of NIV delivered via a facial mask, separated by periods of spontaneous breathing. The pressure-support level during NIV was adjusted until tidal volume reached 6-8 ml/kg and positive end-expiratory pressure (PEEP) 4-5 cmH(2)O. For IPV, the pressurisation frequency was set at 250 cycles/min and driving pressure at 1.2 bar. The pressure-time product of the diaphragm (PTPdi/min) was measured using an oesophageal and gastric double-balloon catheter., Results: Transdiaphragmatic pressure and PTPdi/min improved significantly (p < 0.01), from a median [25th-75th percentiles] of 264 [190-300] to 192 [152-221] cmH(2)O s/min with IPV and from 273 [212-397] to 176 [120-216] cmH(2)O s/min with NIV. Respiratory rate decreased significantly from 23 [19-27] to 22 [17-24] breaths/min for IPV and from 25 [19-28] to 20 [18-22] breaths/min for NIV (p < 0.01). Mean PaCO(2) decreased after NIV (from 46 [42-48] to 41 [36-42] mmHg, p < 0.01) but not after IPV. There was no noticeable effect on oxygenation., Conclusions: IPV is an interesting alternative to NIV in patients at risk for post-extubation respiratory failure. Both NIV and IPV diminished the respiratory rate and work of breathing, but IPV was less effective in improving alveolar ventilation.

Background: Phrenic pacing is an alternative to positive-pressure ventilation in selected patients, mostly in cases of upper spinal cord injury. We evaluated results of phrenic pacing performed by video-assisted thoracic surgery (VATS)., Method: Between 1997 and 2007, after complete neuromuscular investigations, 20 patients requiring full-time ventilation were selected for phrenic pacing (19 with posttraumatic tetraplegia and 1 with congenital central hypoventilation syndrome). Quadripolar cuff electrodes were fixed around each intrathoracic phrenic nerve via bilateral VATS. They were connected to a subcutaneous radiofrequency receiver coupled to an external radiofrequency transmitter. All patients participated in a reconditioning program beginning 2 weeks after implantation and continued until ventilatory weaning., Results: Phrenic pacing was successful in all cases. No intraoperative complications or perioperative mortality were observed. Intraoperative testing detected stimulation thresholds in 19 patients (range, 0.05-2.9 mA). Ventilatory weaning was obtained in 18 patients. Median diaphragm reconditioning time was 6 weeks (2 weeks-11 months). Reconditioning was still in process in a young woman and was not achieved in an elderly woman with a 4-year history of tetraplegia. All the patients weaned from mechanical ventilation reported improved quality of life. Failure or delay in recovery of effective diaphragm contraction was due to nonreversible amyotrophy., Conclusions: VATS implantation of 4-pole electrodes around the intrathoracic phrenic nerve is a safe procedure. Ventilatory weaning correlates with the degree of diaphragmatic amyotrophy. Phrenic pacing, performed as soon as neurologic and orthopedic stabilization is achieved, is the most important prognostic factor for successful weaning., (Copyright © 2011 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Introduction: To evaluate the ability of transthoracic echocardiography (TTE) to detect the effects of spontaneous breathing trial (SBT) on central hemodynamics and to identify indices predictive of cardiac-related weaning failure., Methods: TTE was performed just before and at the end of a 30-min SBT in 117 patients fulfilling weaning criteria. Maximal velocities of mitral E and A waves, deceleration time of E wave (DTE), maximal velocity of E' wave (tissue Doppler at the lateral mitral annulus), and left ventricular (LV) stroke volume were measured. Values of TTE parameters were compared between baseline (pressure support ventilation) and SBT in all patients and according to LV ejection fraction (EF): >50% (n = 58), 35% to 50% (n = 30), and <35% (n = 29). Baseline TTE indices were also compared between patients who were weaned (n = 94) and those who failed (n = 23)., Results: Weaning failure was of cardiac origin in 20/23 patients (87%). SBT resulted in a significant increase in cardiac output and E/A, and a shortened DTE. At baseline, DTE was significantly shorter in patients with LVEF <35% when compared to other subgroups (median [25th-75th percentiles]: 119 ms [90-153]; vs. 187 ms [144-224] vs. 174 ms [152-193]; P < 0.01) and E/E' was greater (7.9 [5.4-9.1] vs. 6.0 [5.3-9.0] vs. 5.2 [4.7-6.0]; P < 0.01). When compared to patients who were successfully weaned, those patients who failed exhibited at baseline a significantly lower LVEF (36% [27-55] vs. 51% [43-55]: P = 0.04) and higher E/E' (7.0 [5.0-9.2] vs. 5.6 [5.2-6.3]: P = 0.04)., Conclusions: TTE detects SBT-induced changes in central hemodynamics. When performed by an experienced operator prior to SBT, TTE helps in identifying patients at high risk of cardiac-related weaning failure when documenting a depressed LVEF, shortened DTE and increased E/E'. Further studies are needed to evaluate the impact of this screening strategy on the weaning process and patient outcome.

Invasive or endotracheal mechanical ventilation can lead to numerous complications likely to burden morbidity and mortality of patients in the intensive care unit. Various safety practices for mechanical ventilation may involve intubation, the mechanical ventilation period, weaning and extubation, the use of tracheostomy as well as non-invasive ventilation. The main objective of safety practices described in this chapter is to prevent or avoid the main risks due to invasive mechanical ventilation.

Introduction: The aim of the study was to determine whether the use of a nurses' protocol-directed weaning procedure, based on the French intensive care society (SRLF) consensus recommendations, was associated with reductions in the duration of mechanical ventilation and intensive care unit (ICU) length of stay in patients requiring more than 48 hours of mechanical ventilation., Methods: This prospective study was conducted in a university hospital ICU from January 2002 through to February 2003. A total of 104 patients who had been ventilated for more than 48 hours and were weaned from mechanical ventilation using a nurses' protocol-directed procedure (cases) were compared with a 1:1 matched historical control group who underwent conventional physician-directed weaning (between 1999 and 2001). Duration of ventilation and length of ICU stay, rate of unsuccessful extubation and rate of ventilator-associated pneumonia were compared between cases and controls., Results: The duration of mechanical ventilation (16.6 +/- 13 days versus 22.5 +/- 21 days; P = 0.02) and ICU length of stay (21.6 +/- 14.3 days versus 27.6 +/- 21.7 days; P = 0.02) were lower among patients who underwent the nurses' protocol-directed weaning than among control individuals. Ventilator-associated pneumonia, ventilator discontinuation failure rates and ICU mortality were similar between the two groups., Discussion: Application of the nurses' protocol-directed weaning procedure described here is safe and promotes significant outcome benefits in patients who require more than 48 hours of mechanical ventilation.