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To compare NHFOV in decreasing the need for mechanical ventilation in the first 7 days of randomization in preterm infants born before 34 weeks of gestational age having nCPAP failure when used as rescue mode compared to NIMV. All eligible neonates were randomized and allocated to either NHFOV or NIMV group after taking the consent from the parents. Standardized protocol was followed on initiation, titration, weaning, and optimization of all the respiratory supports. In this study, a total of 45 neonates were eligible; among them, 20 neonates were randomized to NIMV group and 20 neonates to NHFOV group remaining 5 infants were missed due to the non-availability of a machine ( n  = 4) and missed randomization ( n  = 1). The primary outcome was need for mechanical ventilation within first 7 days of randomization in NIMV and NHFOV group was 45% and 40% ( p  = 0.85, OR = 1.22 (CI 0.35–4.3)). The secondary outcome was a duration of ventilation within 72 h of randomization was 40% vs. 31.6% in NIMV and NHFOV group ( p  = 0.58). Bronchopulmonary dysplasia was 5% and 10% in NIMV and NHFOV group with p  = 0.548, OR = 0.47 (CI 0.39–5.6), and mortality was one infant in NIMV and 3 infants in NHFOV group ( p  = 0.568, OR = 0.29 (CI 0.02–3.1)). Conclusion : NIMV and NHFOV are comparable in reducing the rates of mechanical ventilation within 72 h and within 7 days of post-randomization. Multi-centric trials with large sample sizes are required to prove the hypothesis. Trial registration : www.ctri.nic.in id CTRI/2021/10/037681, registered on October 29, 2021. What is Known: •  NIMV or nHFOV being used as primary as well as post extubation respiratory support in neonates. •  NIMV and nHFOV has shown better clinical outcomes than nCPAP when used as primary and post extubation respiratory support. What is New: •  NIMV and nHFOV can be used as rescue mode after CPAP failure to prevent need for mechanical ventilation. •  nHFOV appears promising as rescue mode in neonates who meets CPAP failure criteria.

AbstractObjectiveTo test the hypothesis that non-invasive high frequency oscillatory ventilation (NHFOV) is more efficacious than nasal continuous positive airway pressure (NCPAP) in reducing invasive mechanical ventilation as primary respiratory support for extremely preterm infants with respiratory distress syndrome.DesignA multicentre, randomised controlled trial.SettingTwenty tertiary neonatal intensive care units in China.Participants342 extremely preterm infants (gestational age between 24 weeks +0 day and 28 weeks +6 days) with respiratory distress syndrome were enrolled in the study between August 2022 and August 2024.InterventionsParticipants were randomly allocated to receive NCPAP or NHFOV as primary respiratory support for respiratory distress syndrome.Main outcome measuresThe primary outcome was treatment failure, defined as the need for invasive mechanical ventilation within 72 hours after birth.ResultsTreatment failure within 72 hours occurred in 27 of` 170 infants (15.9%) in the NHFOV group and 48 of 172 infants (27.9%) in the NCPAP group (risk difference −12.0 percentage points, 95% confidence interval −20.7 to −3.4; P=0.007). Treatment failure within seven days was also lower in the NHFOV group (−12.5 percentage points, 95% confidence interval −21.9 to −3.2; P=0.008) compared with the NCPAP group. All observed associations remained significant after sensitivity analysis including study sites and antenatal steroid use. No significant differences were found in any other secondary outcomes between the two groups.ConclusionsNHFOV appeared superior to NCPAP in reducing the need for intubation when used as a primary respiratory support strategy in extremely preterm infants. Both techniques did not show significant differences in neonatal adverse events.Trial registrationClinicalTrials.gov NCT05141435

Among critically ill adults undergoing tracheal intubation, hypoxemia increases the risk of cardiac arrest and death. The effect of preoxygenation with noninvasive ventilation, as compared with preoxygenation with an oxygen mask, on the incidence of hypoxemia during tracheal intubation is uncertain. In a multicenter, randomized trial conducted at 24 emergency departments and intensive care units in the United States, we randomly assigned critically ill adults (age, ≥18 years) undergoing tracheal intubation to receive preoxygenation with either noninvasive ventilation or an oxygen mask. The primary outcome was hypoxemia during intubation, defined by an oxygen saturation of less than 85% during the interval between induction of anesthesia and 2 minutes after tracheal intubation. Among the 1301 patients enrolled, hypoxemia occurred in 57 of 624 patients (9.1%) in the noninvasive-ventilation group and in 118 of 637 patients (18.5%) in the oxygen-mask group (difference, -9.4 percentage points; 95% confidence interval [CI], -13.2 to -5.6; P<0.001). Cardiac arrest occurred in 1 patient (0.2%) in the noninvasive-ventilation group and in 7 patients (1.1%) in the oxygen-mask group (difference, -0.9 percentage points; 95% CI, -1.8 to -0.1). Aspiration occurred in 6 patients (0.9%) in the noninvasive-ventilation group and in 9 patients (1.4%) in the oxygen-mask group (difference, -0.4 percentage points; 95% CI, -1.6 to 0.7). Among critically ill adults undergoing tracheal intubation, preoxygenation with noninvasive ventilation resulted in a lower incidence of hypoxemia during intubation than preoxygenation with an oxygen mask. (Funded by the U.S. Department of Defense; PREOXI ClinicalTrials.gov number, NCT05267652.).

Background Apnoea, desaturations and bradycardias are common problems in preterm infants which can be treated with nasal continuous positive airway pressure (NCPAP) and nasal intermittent positive pressure ventilation (NIPPV). It is unclear whether synchronised NIPPV (SNIPPV) would be even more effective. Objective To assess the effects of flow-SNIPPV, NIPPV and NCPAP on the rate of desaturations and bradycardias in preterm infants and, secondarily, to evaluate their influence on pattern of breathing and gas exchange. Patients and methods Nineteen infants (mean gestational age at study 30 weeks, 9 boys) with apnoeic spells were enrolled in a randomised controlled trial with a cross-over design. They received flow-SNIPPV, NIPPV and NCPAP for 4 h each. All modes were provided by a nasal conventional ventilator able to provide synchronisation by a pneumotachograph. The primary outcome was the event rate of desaturations (≤80% arterial oxygen saturation) and bradycardias (≤80 bpm) per hour, obtained from cardiorespiratory recordings. The incidence of central apnoeas (≥10 s) as well as baseline heart rate, FiO2, SpO2, transcutaneous blood gases and respiratory rate were also evaluated. Results The median event rate per hour during flow-SNIPPV, NIPPV and NCPAP was 2.9, 6.1 and 5.9, respectively (p<0.001 and 0.009, compared with flow-SNIPPV). Central apnoeas per hour were 2.4, 6.3 and 5.4, respectively (p=0.001, for both compared with flow-SNIPPV), while no differences in any other parameter studied were recorded. Conclusions Flow-SNIPPV seems more effective than NIPPV and NCPAP in reducing the incidence of desaturations, bradycardias and central apnoea episodes in preterm infants.

Purpose Limited data exist on the correlation between higher flow rates of high-flow nasal cannula (HFNC) and its physiologic effects in patients with acute hypoxemic respiratory failure (AHRF). We assessed the effects of HFNC delivered at increasing flow rate on inspiratory effort, work of breathing, minute ventilation, lung volumes, dynamic compliance and oxygenation in AHRF patients. Methods A prospective randomized cross-over study was performed in non-intubated patients with patients AHRF and a PaO 2 /FiO 2 (arterial partial pressure of oxygen/fraction of inspired oxygen) ratio of ≤300 mmHg. A standard non-occlusive facial mask and HFNC at different flow rates (30, 45 and 60 l/min) were randomly applied, while maintaining constant FiO 2 (20 min/step). At the end of each phase, we measured arterial blood gases, inspiratory effort, based on swings in esophageal pressure (ΔPes) and on the esophageal pressure–time product (PTP Pes ), and lung volume, by electrical impedance tomography. Results Seventeen patients with AHRF were enrolled in the study. At increasing flow rate, HFNC reduced ΔPes ( p  < 0.001) and PTP Pes ( p  < 0.001), while end-expiratory lung volume (ΔEELV), tidal volume to ΔPes ratio ( V T /ΔPes, which corresponds to dynamic lung compliance) and oxygenation improved ( p  < 0.01 for all factors). Higher HFNC flow rate also progressively reduced minute ventilation ( p  < 0.05) without any change in arterial CO 2 tension ( p  = 0.909). The decrease in ΔPes, PTP Pes and minute ventilation at increasing flow rates was better described by exponential fitting, while ΔEELV, V T /ΔPes and oxygenation improved linearly. Conclusions In this cohort of patients with AHRF, an increasing HFNC flow rate progressively decreased inspiratory effort and improved lung aeration, dynamic compliance and oxygenation. Most of the effect on inspiratory workload and CO 2 clearance was already obtained at the lowest flow rate.

Purpose Noninvasive 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. Methods Highly 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. Results We 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. Conclusions In highly selected hypoxemic patients, early extubation followed by immediate NIV application reduced the days spent on invasive ventilation without affecting ICU LOS.

IntroductionNon-invasive high-frequency oscillatory ventilation (nHFOV) is an extension of nasal continuous positive airway pressure (nCPAP) support in neonates. We aimed to compare global and regional distribution of lung volumes during nHFOV versus nCPAP.MethodsIn 30 preterm infants enrolled in a randomised crossover trial comparing nHFOV with nCPAP, electrical impedance tomography data were recorded in prone position. For each mode of respiratory support, four episodes of artefact-free tidal ventilation, each comprising 30 consecutive breaths, were extracted. Tidal volumes (VT) in 36 horizontal slices, indicators of ventilation homogeneity and end-expiratory lung impedance (EELI) for the whole lung and for four horizontal regions of interest (non-gravity-dependent to gravity-dependent; EELINGD, EELImidNGD, EELImidGD, EELIGD) were compared between nHFOV and nCPAP. Aeration homogeneity ratio (AHR) was determined by dividing aeration in non-gravity-dependent parts of the lung through gravity-dependent regions.Main resultsOverall, 228 recordings were analysed. Relative VT was greater in all but the six most gravity-dependent lung slices during nCPAP (all p<0.05). Indicators of ventilation homogeneity were similar between nHFOV and nCPAP (all p>0.05). Aeration was increased during nHFOV (mean difference (95% CI)=0.4 (0.2 to 0.6) arbitrary units per kilogram (AU/kg), p=0.013), mainly due to an increase in non-gravity-dependent regions of the lung (∆EELINGD=6.9 (0.0 to 13.8) AU/kg, p=0.028; ∆EELImidNGD=6.8 (1.2 to 12.4) AU/kg, p=0.009). Aeration was more homogeneous during nHFOV compared with nCPAP (mean difference (95% CI) in AHR=0.01 (0.00 to 0.02), p=0.0014).ConclusionAlthough regional ventilation was similar between nHFOV and nCPAP, end-expiratory lung volume was higher and aeration homogeneity was slightly improved during nHFOV. The aeration difference was greatest in non-gravity dependent regions, possibly due to the oscillatory pressure waveform. The clinical importance of these findings is still unclear.

Background High-flow nasal cannula (HFNC) oxygen therapy is being increasingly used to prevent post-extubation hypoxemic respiratory failure and reintubation. However, evidence to support the use of HFNC in chronic obstructive pulmonary disease (COPD) patients with hypercapnic respiratory failure after extubation is limited. This study was conducted to test if HFNC is non-inferior to non-invasive ventilation (NIV) in preventing post-extubation treatment failure in COPD patients previously intubated for hypercapnic respiratory failure. Methods COPD patients with hypercapnic respiratory failure who were already receiving invasive ventilation were randomized to HFNC or NIV at extubation at two large tertiary academic teaching hospitals. The primary endpoint was treatment failure, defined as either resumption of invasive ventilation or switching to the other study treatment modality (NIV for patients in the NFNC group or vice versa). Results Ninety-six patients were randomly assigned to the HFNC group or NIV group. After secondary exclusion, 44 patients in the HFNC group and 42 patients in the NIV group were included in the analysis. The treatment failure rate in the HFNC group was 22.7% and 28.6% in the NIV group—risk difference of − 5.8% (95% CI, − 23.8–12.4%, p  = 0.535), which was significantly lower than the non-inferior margin of 9%. Analysis of the causes of treatment failure showed that treatment intolerance in the HFNC group was significantly lower than that in the NIV group, with a risk difference of − 50.0% (95% CI, − 74.6 to − 12.9%, p  = 0.015). One hour after extubation, the mean respiratory rates of both groups were faster than their baseline levels before extubation ( p  < 0.050). Twenty-four hours after extubation, the respiratory rate of the HFNC group had returned to baseline, but the NIV group was still higher than the baseline. Forty-eight hours after extubation, the respiratory rates of both groups were not significantly different from the baseline. The average number of daily airway care interventions in the NIV group was 7 (5–9.3), which was significantly higher than 6 (4–7) times in the HFNC group ( p  = 0.006). The comfort score and incidence of nasal and facial skin breakdown of the HFNC group was also significantly better than that of the NIV group [7 (6–8) vs 5 (4–7), P  < 0.001] and [0 vs 9.6%, p  = 0.027], respectively. Conclusion Among COPD patients with severe hypercapnic respiratory failure who received invasive ventilation, the use of HFNC after extubation did not result in increased rates of treatment failure compared with NIV. HFNC also had better tolerance and comfort than NIV. Trial registration chictr.org ( ChiCTR1800018530 ). Registered on 22 September 2018, http://www.chictr.org.cn/usercenter.aspx

Purpose High-flow nasal cannula oxygen (HFNC) has the potential to provide apnoeic oxygenation. We decided to assess in a proof-of-concept study whether the addition of HFNC to non-invasive ventilation (NIV) could reduce oxygen desaturation during intubation, compared with NIV alone for preoxygenation, in severely hypoxaemic intensive care unit (ICU) patients with respiratory failure. Methods We conducted a randomised, controlled, single-centre trial with assessor-blinded outcome assessment in patients admitted to the ICU. Hypoxaemic patients requiring orotracheal intubation for respiratory failure were randomised to receive preoxygenation using HFNC [flow = 60 L/min, fraction of inspired oxygen (FiO 2 ) = 100 %] combined with NIV (pressure support = 10 cmH 2 O, positive end-expiratory pressure = 5 cmH 2 O, FiO 2  = 100 %) in the intervention group or NIV alone in the reference group prior to intubation. The primary outcome was the lowest oxygen saturation (SpO 2 ) during the intubation procedure. Secondary outcomes were intubation-related complications and ICU mortality. Results Between July 2015 and February 2016, we randomly assigned 25 and 24 patients to the intervention and reference groups, respectively. In both groups the main reasons for respiratory failure were pneumonia and ARDS. During the intubation procedure, the lowest SpO 2 values were significantly higher in the intervention group than in the reference group [100 (95–100) % vs. 96 (92–99) %, p  = 0.029]. After exclusion of two patients from analysis for protocol violation, no (0 %) patients in the intervention group and five (21 %) patients in the reference group had SpO 2 below 80 % ( p  = 0.050). We recorded no significant difference between the groups in intubation-related complications or ICU mortality. Conclusions A novel strategy for preoxygenation in hypoxaemic patients, adding HFNC for apnoeic oxygenation to NIV prior to orotracheal intubation, may be more effective in reducing the severity of oxygen desaturation than the reference method using NIV alone.

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