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Background Although cumulative studies have demonstrated a beneficial effect of high-flow nasal cannula oxygen (HFNC) in acute hypercapnic respiratory failure, randomized trials to compare HFNC with non-invasive ventilation (NIV) as initial treatment in acute exacerbations of chronic obstructive pulmonary disease (AECOPD) patients with acute-moderate hypercapnic respiratory failure are limited. The aim of this randomized, open label, non-inferiority trial was to compare treatment failure rates between HFNC and NIV in such patients. Methods Patients diagnosed with AECOPD with a baseline arterial blood gas pH between 7.25 and 7.35 and PaCO 2  ≥ 50 mmHg admitted to two intensive care units (ICUs) at a large tertiary academic teaching hospital between March 2018 and December 2022 were randomly assigned to HFNC or NIV. The primary endpoint was the rate of treatment failure, defined as endotracheal intubation or a switch to the other study treatment modality. Secondary endpoints were rates of intubation or treatment change, blood gas values, vital signs at one, 12, and 48 h, 28-day mortality, as well as ICU and hospital lengths of stay. Results 225 total patients (113 in the HFNC group and 112 in the NIV group) were included in the intention-to-treat analysis. The failure rate of the HFNC group was 25.7%, while the NIV group was 14.3%. The failure rate risk difference between the two groups was 11.38% (95% CI 0.25–21.20, P  = 0.033), which was higher than the non-inferiority cut-off of 9%. In the per-protocol analysis, treatment failure occurred in 28 of 110 patients (25.5%) in the HFNC group and 15 of 109 patients (13.8%) in the NIV group (risk difference, 11.69%; 95% CI 0.48–22.60). The intubation rate in the HFNC group was higher than in the NIV group (14.2% vs 5.4%, P  = 0.026). The treatment switch rate, ICU and hospital length of stay or 28-day mortality in the HFNC group were not statistically different from the NIV group (all P  > 0.05). Conclusion HFNC was not shown to be non-inferior to NIV and resulted in a higher incidence of treatment failure than NIV when used as the initial respiratory support for AECOPD patients with acute-moderate hypercapnic respiratory failure. Trial registration : chictr.org (ChiCTR1800014553). Registered 21 January 2018, http://www.chictr.org.cn

PurposeNoninvasive ventilation (NIV) may facilitate withdrawal of invasive mechanical ventilation (i-MV) and shorten intensive care unit (ICU) length of stay (LOS) in hypercapnic patients, while data are lacking on hypoxemic patients. We aim to determine whether NIV after early extubation reduces the duration of i-MV and ICU LOS in patients recovering from hypoxemic acute respiratory failure.MethodsHighly selected non-hypercapnic hypoxemic patients were randomly assigned to receive NIV after early or standard extubation. Co-primary end points were duration of i-MV and ICU LOS. Secondary end points were treatment failure, severe events (hemorrhagic, septic, cardiac, renal or neurologic episodes, pneumothorax or pulmonary embolism), ventilator-associated pneumonia (VAP) or tracheobronchitis (VAT), tracheotomy, percent of patients receiving sedation after study enrollment, hospital LOS, and ICU and hospital mortality.ResultsWe enrolled 130 consecutive patients, 65 treatments and 65 controls. Duration of i-MV was shorter in the treatment group than for controls [4.0 (3.0–7.0) vs. 5.5 (4.0–9.0) days, respectively, p = 0.004], while ICU LOS was not significantly different [8.0 (6.0–12.0) vs. 9.0 (6.5–12.5) days, respectively (p = 0.259)]. Incidence of VAT or VAP (9% vs. 25%, p = 0.019), rate of patients requiring infusion of sedatives after enrollment (57% vs. 85%, p = 0.001), and hospital LOS, 20 (13–32) vs. 27(18–39) days (p = 0.043) were all significantly reduced in the treatment group compared with controls. There were no significant differences in ICU and hospital mortality or in the number of treatment failures, severe events, and tracheostomies.ConclusionsIn highly selected hypoxemic patients, early extubation followed by immediate NIV application reduced the days spent on invasive ventilation without affecting ICU LOS.

PurposeAlthough noninvasive ventilation (NIV) may reduce reintubation in patients with acute hypoxemic respiratory failure following abdominal surgery, this strategy has not been specifically assessed in patients with obesity.MethodsWe conducted a post hoc analysis of a multicenter randomized controlled trial comparing NIV delivered via facial mask to standard oxygen therapy among patients with obesity and acute hypoxemic respiratory failure within 7 days after abdominal surgery. The primary outcome was reintubation within 7 days. Secondary outcomes were invasive ventilation-free days at day 30, intensive care unit (ICU)-acquired pneumonia and 30-day survival.ResultsAmong 293 patients with hypoxemic respiratory failure following abdominal surgery, 76 (26%) patients had obesity and were included in the intention-to-treat analysis. Reintubation rate was significantly lower with NIV (13/42, 31%) than with standard oxygen therapy (19/34, 56%) within 7 days (absolute difference: − 25%, 95% confidence interval (CI) − 49 to − 1%, p = 0.03). NIV was associated with significantly more invasive ventilation-free days compared with standard oxygen therapy (27.1 ± 8.6 vs 22.7 ± 11.1 days; p = 0.02), while fewer patients developed ICU-acquired pneumonia (1/42, 2% vs 6/34, 18%; p = 0.04). The 30-day survival was 98% in the NIV group (41/42) versus 85% in the standard oxygen therapy (p = 0.08). In patients with body mass index (BMI) < 30 kg/m2, no significant difference was observed between NIV (36/105, 34%) and standard oxygen therapy (47/109, 43%, p = 0.03). An interaction test showed no statistically significant difference between the two subsets (BMI ≥ 30 kg/m2 and BMI < 30 kg/m2).ConclusionsAmong patients with obesity and hypoxemic respiratory failure following abdominal surgery, use of NIV compared with standard oxygen therapy reduced the risk of reintubation within 7 days, contrary to patients without obesity. However, no interaction was found according to the presence of obesity or not, suggesting either a lack of power to conclude in the non-obese subgroup despite existing differences, or that the statistical difference found in the overall sample was driven by a large effect in the obese subsets.

Background Extubation failure leading to reintubation is associated with high mortality. In patients at high-risk of extubation failure, clinical practice guidelines recommend prophylactic non-invasive ventilation (NIV) over high-flow nasal oxygen (HFNO) immediately after extubation. However, the physiological effects supporting the beneficial effect of NIV have been poorly explored. We hypothesized that NIV may reduce patient inspiratory efforts to a greater extent than HFNO after extubation. Methods In a prospective physiological study, patients at high-risk of extubation failure (> 65 years old or underlying cardiac or respiratory disease) were included to receive after planned extubation prophylactic NIV and HFNO in a randomized crossover order, followed by standard oxygen. Inspiratory efforts were assessed by calculation of the simplified esophageal pressure–time-product per minute (sPTP es in cmH 2 O s/min). Tidal volumes, distribution and homogeneity of ventilation were estimated using electrical impedance tomography. Results Twenty patients were retained in the analysis. Inspiratory efforts were lower with NIV than with HFNO (sPTP es 196 cm H 2 O s/min [116–234] vs. 220 [178–327], p  < 0.001) whereas tidal volumes were larger with NIV than with HFNO (8.4 mL/kg of predicted body weight [6.7–9.9] vs. 6.9 [5.3–8.6], p  = 0.005). There was a non-significant increase in dorsal region ventilation under NIV compared to HFNO. Conclusions In patients at high-risk of extubation failure, prophylactic NIV significantly decreased inspiratory efforts with increased tidal volumes compared to HFNO. The clinical benefits of NIV to prevent reintubation in patients at high-risk may be mediated by these physiological effects. Trial registration Clinicaltrials.gov: ID NCT04036175), retrospectively registered 17 June 2019.

Background The purpose of this study was to compare the effects of intensive nutritional care (INC) and laparoscopic adjustable gastric banding (LAGB) on nocturnal non-invasive ventilation (NIV) requirement in obese patients using short-, medium-, and long-term follow-up data. Methods This prospective randomized controlled trial included obese patients with obstructive sleep apnea (OSA) treated by NIV. Patients were randomized to the INC and LAGB groups. The primary endpoint was the theoretical rate of weaning from NIV at years 1 and 3. Data were also collected from patients 10 years after randomization. Results Sixty-three patients were randomized. The rate of weaning from NIV did not differ significantly between the LAGB and INC groups at year 1 (35 vs. 13 %) or year 3 (14 vs. 21 %). Percentages of excess weight loss were greater in the LAGB group than in the INC group at years 1 (33 vs. 15 %, p = 0.002) and 3 (27 vs. 8 %, p = 0.014). Decreases in the apnea-hypopnea index were observed in the LAGB group from baseline to year 1 (−44 %, p = 0.001) and from baseline to year 3 (−26 %, p = 0.044). After 10 years, the weaning rate was low and similar between groups. Conclusion LAGB was not superior to INC for weaning from NIV at 1 and 3 years in obese patients with OSA.

Introduction Non-Invasive Ventilation (NIV) is a crucial therapy for managing acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD) with hypercapnic respiratory failure. Research has shown that NIV can decrease the rate of endotracheal intubation, length of hospital and Intensive Care Unit stays, and mortality. There are three main strategies for weaning patients off NIV: gradual reduction of NIV duration, gradual reduction of NIV pressure support, and immediate cessation of NIV. Aim To compare the rate of successful withdrawal of COPD patients with acute hypercapnic respiratory failure, one group will use a stepwise reduction of duration of NIV, while the other group will use a stepwise reduction of pressure support. Materials and methods This study was a prospective observational study conducted at the Department of Pulmonary Medicine, Institute of Chest Diseases, Government Medical College, Kozhikode, over a period of 15 months. The study population consisted of all COPD patients admitted to the Pulmonary Medicine ward or ICU with acute hypercapnic respiratory failure who were managed with non-invasive ventilation (NIV) without the need for invasive mechanical ventilation. Exclusions included patients requiring NIV for respiratory diseases other than COPD, those with significant comorbidities like acute left ventricular failure or fluid overload states as in chronic kidney disease, COVID-19 positive patients, patients on home NIV, patients who needed intubation early in treatment, and patients unwilling to participate in the study. The sample size was 140. Initial NIV settings and other management decisions prior to enrolment in the study were made by the treating physician according to standard protocols. Once weaning criteria were met (i.e., arterial pH > 7.35, SpO2 ≥ 90% at an FiO2 ≤ 50%, respiratory rate ≤ 25 breaths per minute, heart rate ≤ 120 beats per minute, systolic BP > 90 mm Hg, and no signs of respiratory distress), patients were assigned to either group 1 or group 2 by purposive sampling. Group 1: stepwise reduction of duration of NIV use, with a reduction to 16 h per day on day 1 of enrolment, 12 h on day 2 (including 6–8 h of nocturnal NIV), 6–8 h on day 3, and NIV withdrawal on day 4. Group 2: stepwise reduction of pressure support, with pressure support reduced by 2–4 cm every 4–6 h until Inspiratory Positive Airway Pressure is < 8 cm H2O and Expiratory Positive Airway Pressure is < 4 cm H2O, followed by NIV withdrawal. The clinical outcome was classified as either improved or weaning failure. Improved was defined as an objective or subjective sense of improvement. Weaning failure was defined as the presence of any of the following: respiratory rate ≥ 25/minute or increase of ≥ 50% from baseline, heart rate ≥ 140/minute or increase of ≥ 20% from baseline, SpO2 ≤ 90% on FiO2 ≥ 50%, arterial pH ≤ 7.35, or respiratory distress. Data was collected using a pro forma that included demographic details, smoking status, GOLD COPD category, comorbidities, and vital signs. ABG parameters, NIV settings at the time of hospital admission, at the time of study enrolment, and 48 h after weaning were also recorded. Independent sample t-test was used to test the statistical significance of the difference between means of variables between the two groups. Pearson Chi square test and Fisher’s exact test were used to compare categorical variables between the groups. A p-value of < 0.05 was considered statistically significant. Results NIV was successfully withdrawn in 56/70 (80%) and 50/70 (71.4%) patients in Groups 1 and 2, respectively. This difference was not statistically significant. The length of hospital stay was longer in the stepwise reduction of duration group (Group 1), but this was not statistically significant. Conclusion On comparison of two methods of NIV withdrawal, it was found that neither method is superior to the other in terms of weaning failure, intubation rates, and average length of hospital stay.

Background. There is a growing controversy about the use of oronasal masks (ONM) or total facemask (TFM) in noninvasive positive pressure ventilation (NPPV), so we designed a trial to compare the uses of these two masks in terms of effectiveness and comfort. Methods. Between February and November 2014, a total of 48 patients with respiratory failure were studied. Patients were randomized to receive NPPV via ONM or TFM. Data were recorded at 60 minutes and six and 24 hours after intervention. Patient comfort was assessed using a questionnaire. Data were analyzed using t-test and chi-square test. Repeated measures ANOVA and Mann–Whitney U test were used to compare clinical and laboratory data. Results. There were no differences in venous blood gas (VBG) values between the two groups (P>0.05). However, at six hours, TFM was much more effective in reducing the partial pressure of carbon dioxide (PCO2) (P=0.04). Patient comfort and acceptance were statistically similar in both groups (P>0.05). Total time of NPPV was also similar in the two groups (P>0.05). Conclusions. TFM was superior to ONM in acute phase of respiratory failure but not once the patients were out of acute phase.

Discoveries have emerged highlighting the complex nature of the interorgan cross-talk between the kidney and the lung. Vascular rigidity, neurohormonal activation, tissue hypoxia, and abnormal immune cell signaling have been identified as common pathways leading to the development and progression of chronic kidney disease. However, our understanding of the causal relationships between lung injury and kidney injury is not precise. This review discusses a number of features and mechanisms of renal dysfunction in pulmonary disorders in relation to respiratory acidosis, impaired gas exchange, systemic congestion, respiratory support/replacement therapies, and other issues relevant to the clinical care of these patients. Biotrauma due to injurious ventilatory strategies can lead to the release of mediators into the lung, which may then translocate into the systemic circulation and cause end-organ dysfunction, including renal dysfunction. Right ventricular dysfunction and congestive states may contribute to alterations of renal perfusion and oxygenation, leading to diuretic resistance and recurrent hospitalization. In patients with concomitant respiratory failure, noninvasive ventilation represents a promising treatment option for the correction of impaired renal microcirculation and endothelial dysfunction. In patients requiring extracorporeal membrane oxygenation, short- and long-term monitoring of kidney function is warranted, as they are at highest risk of developing acute kidney injury and fluid overload.

Background The efficacy and safety of high flow nasal therapy (HFNT) in patients with acute hypercapnic exacerbation of chronic obstructive pulmonary disease (AECOPD) are unclear. Our aim was to evaluate the short-term effect of HFNT versus NIV in patients with mild-to-moderate AECOPD, with the hypothesis that HFNT is non-inferior to NIV on CO 2 clearance after 2 h of treatment. Methods We performed a multicenter, non-inferiority randomized trial comparing HFNT and noninvasive ventilation (NIV) in nine centers in Italy. Patients were eligible if presented with mild-to-moderate AECOPD (arterial pH 7.25–7.35, PaCO 2  ≥ 55 mmHg before ventilator support). Primary endpoint was the mean difference of PaCO 2 from baseline to 2 h (non-inferiority margin 10 mmHg) in the per-protocol analysis. Main secondary endpoints were non-inferiority of HFNT to NIV in reducing PaCO 2 at 6 h in the per-protocol and intention-to-treat analysis and rate of treatment changes. Results Seventy-nine patients were analyzed (80 patients randomized). Mean differences for PaCO 2 reduction from baseline to 2 h were − 6.8 mmHg (± 8.7) in the HFNT and − 9.5 mmHg (± 8.5) in the NIV group ( p  = 0.404). By 6 h, 32% of patients (13 out of 40) in the HFNT group switched to NIV and one to invasive ventilation. HFNT was statistically non-inferior to NIV since the 95% confidence interval (CI) upper boundary of absolute difference in mean PaCO 2 reduction did not reach the non-inferiority margin of 10 mmHg (absolute difference 2.7 mmHg; 1-sided 95% CI 6.1; p  = 0.0003). Both treatments had a significant effect on PaCO 2 reductions over time, and trends were similar between groups. Similar results were found in both per-protocol at 6 h and intention-to-treat analysis. Conclusions HFNT was statistically non-inferior to NIV as initial ventilatory support in decreasing PaCO 2 after 2 h of treatment in patients with mild-to-moderate AECOPD, considering a non-inferiority margin of 10 mmHg. However, 32% of patients receiving HFNT required NIV by 6 h. Further trials with superiority design should evaluate efficacy toward stronger patient-related outcomes and safety of HFNT in AECOPD. Trial registration : The study was prospectively registered on December 12, 2017, in ClinicalTrials.gov (NCT03370666).

Purpose To develop and validate a scale using variables easily obtained at the bedside for prediction of failure of noninvasive ventilation (NIV) in hypoxemic patients. Methods The test cohort comprised 449 patients with hypoxemia who were receiving NIV. This cohort was used to develop a scale that considers heart rate, acidosis, consciousness, oxygenation, and respiratory rate (referred to as the HACOR scale) to predict NIV failure, defined as need for intubation after NIV intervention. The highest possible score was 25 points. To validate the scale, a separate group of 358 hypoxemic patients were enrolled in the validation cohort. Results The failure rate of NIV was 47.8 and 39.4% in the test and validation cohorts, respectively. In the test cohort, patients with NIV failure had higher HACOR scores at initiation and after 1, 12, 24, and 48 h of NIV than those with successful NIV. At 1 h of NIV the area under the receiver operating characteristic curve was 0.88, showing good predictive power for NIV failure. Using 5 points as the cutoff value, the sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy for NIV failure were 72.6, 90.2, 87.2, 78.1, and 81.8%, respectively. These results were confirmed in the validation cohort. Moreover, the diagnostic accuracy for NIV failure exceeded 80% in subgroups classified by diagnosis, age, or disease severity and also at 1, 12, 24, and 48 h of NIV. Among patients with NIV failure with a HACOR score of >5 at 1 h of NIV, hospital mortality was lower in those who received intubation at ≤12 h of NIV than in those intubated later [58/88 (66%) vs. 138/175 (79%); p  = 0.03). Conclusions The HACOR scale variables are easily obtained at the bedside. The scale appears to be an effective way of predicting NIV failure in hypoxemic patients. Early intubation in high-risk patients may reduce hospital mortality.