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Nasal highflow (NHF) provides a warmed and humidified air stream up to 60 L/min. Recent data demonstrated a positive effect in patients with acute hypoxemic respiratory failure, especially when caused by pneumonia. Preliminary data show a decrease in hypercapnia in patients with COPD. Therefore, NHF should be evaluated as a new ventilatory support device. This study was conducted to assess the impact of different flow rates on ventilatory parameters in patients with COPD. This interventional clinical study was performed with patients suffering from severe COPD. The aim was to characterize flow-dependent changes in mean airway pressure, breathing volumes, breathing frequency, and decrease in partial pressure of CO2 (pCO2). Mean airway pressure was measured in the nasopharyngeal space (19 patients). To evaluate breathing volumes, we used a polysomnographic device (18 patients). All patients received 20 L/min, 30 L/min, 40 L/min, and 50 L/min and - to illustrate the effects - nasal continuous positive airway pressure and nasal bilevel positive airway pressure. Capillary blood gas analyses were performed in 54 patients with hypercapnic COPD before and two hours after the use of NHF. We compared the extent of decrease in pCO2 when using 20 L/min and 30 L/min. Additionally, comfort and dyspnea during the use of NHF were surveyed. NHF resulted in a minor flow dependent increase in mean airway pressure. Tidal volume increased, and breathing rate decreased. The calculated minute volume decreased under NHF breathing. In spite of this fact, hypercapnia decreased with increasing flow (20 L/min vs 30 L/min). Additionally, an improvement in dyspnea was observed. The rapid shallow breathing index shows a decrease when using NHF. NHF leads to a flow-dependent reduction in pCO2. This is most likely achieved by a washout of the respiratory tract and a functional reduction in dead space. In summary, NHF enhances effectiveness of breathing in patients with COPD, reduces pCO2, the work of breathing, and rapid shallow breathing index as an indicator of respiratory work load.

Background High flow nasal cannula therapy (HFNC) and continuous positive airway pressure (CPAP) are two widely used modes of non-invasive respiratory support in paediatric critical care units. The FIRST-ABC randomised controlled trials (RCTs) evaluated the clinical and cost-effectiveness of HFNC compared with CPAP in two distinct critical care populations: acutely ill children (‘step-up’ RCT) and extubated children (‘step-down’ RCT). Clinical effectiveness findings (time to liberation from all forms of respiratory support) showed that HFNC was non-inferior to CPAP in the step-up RCT, but failed to meet non-inferiority criteria in the step-down RCT. This study evaluates the cost-effectiveness of HFNC versus CPAP. Methods All-cause mortality, health-related Quality of Life (HrQoL), and costs up to six months were reported using FIRST-ABC RCTs data. HrQoL was measured with the age-appropriate Paediatric Quality of Life Generic Core Scales questionnaire and mapped onto the Child Health Utility 9D index score at six months. Quality-Adjusted Life Years (QALYs) were estimated by combining HrQoL with mortality. Costs at six months were calculated by measuring and valuing healthcare resources used in paediatric critical care units, general medical wards and wider health service. The cost-effectiveness analysis used regression methods to report the cost-effectiveness of HFNC versus CPAP at six months and summarised the uncertainties around the incremental cost-effectiveness results. Results In both RCTs, the incremental QALYs at six months were similar between the randomised groups. The estimated incremental cost at six months was − £4565 (95% CI − £11,499 to £2368) and − £5702 (95% CI − £11,328 to − £75) for step-down and step-up RCT, respectively. The incremental net benefits of HFNC versus CPAP in step-down RCT and step-up RCT were £4388 (95% CI − £2551 to £11,327) and £5628 (95% CI − £8 to £11,264) respectively. The cost-effectiveness results were surrounded by considerable uncertainties. The results were similar across most pre-specified subgroups, and the base case results were robust to alternative assumptions. Conclusions HFNC compared to CPAP as non-invasive respiratory support for critically-ill children in paediatric critical care units reduces mean costs and is relatively cost-effective overall and for key subgroups, although there is considerable statistical uncertainty surrounding this result.

Background Noninvasive neurally adjusted ventilator assist (NIV-NAVA) was introduced to our clinical practice via a pilot and a randomized observational study to assess its safety, feasibility, and short-term physiological effects. Methods The pilot protocol applied NIV-NAVA to 11 infants on nasal CPAP, high-flow nasal cannula, or nasal intermittent mandatory ventilation (NIMV), in multiple 2- to 4-h periods of NIV-NAVA for comparison. This provided the necessary data to design a randomized, controlled observational crossover study in eight additional infants to compare the physiological effects of NIV-NAVA with NIMV during 2-h steady-state conditions. We recorded the peak inspiratory pressure (PIP), FiO 2 , Edi, oxygen saturations (histogram analysis), transcutaneous PCO 2 , and movement with an Acoustic Respiratory Movement Sensor. Results The NAVA catheter was used for 81 patient days without complications. NIV-NAVA produced significant reductions (as a percentage of measurements on NIMV) in the following: PIP, 13%; FiO 2 , 13%; frequency of desaturations, 42%; length of desaturations, 32%; and phasic Edi, 19%. Infant movement and caretaker movement were reduced by 42% and 27%, respectively. Neural inspiratory time was increased by 39 ms on NIV-NAVA, possibly due to Head’s paradoxical reflex. Conclusion NIV-NAVA was a safe, alternative mode of noninvasive support that produced beneficial short-term physiological effects, especially compared with NIMV.

Noninvasive ventilation (NIV) is beneficial in acute respiratory failure (ARF) caused by chest trauma; however, NIV-related complications affect the efficacy. We evaluated whether NIV with helmet decreases the incidence of complications and improves its effects in a single center. Patients with ARF after chest trauma were randomized to receive NIV with helmet or face mask. The primary outcome was the rate of NIV-related complications. Secondary outcomes were PaO 2 /FiO 2 , patient’s tolerance, intubation rate, length of intensive care unit (ICU) stay, and ICU mortality. The trial was terminated early after an interim analysis with 59 patients. The incidence of complications was lower in the helmet group [10% (3/29) vs 43% (13/30), P  = 0.004], and PaO 2 /FiO 2 s were higher at 1 h and at the end of NIV (253.14 ± 64.74 mmHg vs 216.06 ± 43.86 mmHg, 277.07 ± 84.89 mmHg vs 225.81 ± 63.64 mmHg, P  = 0.013 and 0.012) compared with them in face mask group. More patients reported excellent tolerance of the helmet vs face mask after 4 h of NIV [83% (24/29) vs 47% (14/30), P  = 0.004] and at the end of NIV [69% (20/29) vs 30% (9/30), P  = 0.03]. Differences in intubation rate, ICU stay, and mortality were non-significant ( P  = 0.612, 0.100, 1.000, respectively). NIV with helmet decreased NIV-related complications, increased PaO 2 /FiO 2 , and improved tolerance compared with NIV with face mask in patients with chest trauma. Trial registration: Registered in the Chinese Clinical Trial Registry (ChiCTR1900025915), a WHO International Clinical Trials Registry Platform ( http://www.chictr.org.cn/searchprojen.aspx ).

Objective To compare patient comfort in preterm infants treated with heated humidified high flow nasal cannulae (HHHFNC) versus nasal continuous positive airway pressure (NCPAP). Design Randomised cross-over trial (2×24 h). Setting Single tertiary neonatal unit. Patients 20 infants less than 34 weeks postmenstrual age treated with NCPAP due to mild respiratory illness. Interventions After parental consent, infants were randomised to 24 h of treatment with NCPAP or HHHFNC followed by 24 h of the alternate therapy. Main outcome measures Primary outcome was patient comfort assessed by the EDIN (neonatal pain and discomfort) scale. Secondary outcomes were respiratory parameters (respiratory rate, FiO2, SpO2, TcPCO2), ambient noise, salivary cortisol and parental assessments of their child. Results We found no differences between HHHFNC and NCPAP in mean cumulative EDIN score (10.7 vs 11.1, p=0.25) or ambient noise (70 vs 74 dBa, p=0.18). Parents assessed HHHFNC treatment as significantly better in the three domains, 1) child satisfied, 2) parental contact and interaction and 3) possibility to take part in care. Mean respiratory rate over 24 h was lower during HHHFNC than CPAP (41 vs 46, p=0.001). Other respiratory parameters were similar. Conclusions Using EDIN scale, we found no difference in patient comfort with HHHFNC versus NCPAP. However, parents preferred HHHFNC, and during HHHFNC respiratory rate was lower than during NCPAP. ClinicalTrials.gov, number NCT01526226.

Background: CO 2 rebreathing is one of the risks associated with noninvasive ventilation (NIV), possibly contributing to failure. In a bench study, we showed that a novel mask design, with separate limbs for inflow and outflow gases, significantly reduced CO 2 rebreathing in different ventilation settings. Objectives: The study aimed to test whether a new mask design could 1) reduce CO 2 rebreathing in healthy volunteers during NIV (phase 1) and 2) reduce minute ventilation (phase 2). Materials and Methods: Healthy volunteers were randomly assigned to NIV using two masks in a crossover design: a traditional single-limb mask for inflow and outflow gases and a mask with two separated limbs. In phase 1, six ventilation settings were tested for each mask: CPAP (PEEP 5 cmH 2 O) and pressure support ventilation (PSV, PS Level 5 cmH 2 O) using a mechanical ventilator with a bias flow of 8 or 20 L/min; free-flow CPAP (PEEP 5 cmH 2 O) with 60 or 90 L/min of gas flow. A nasal cannula was inserted in one nostril of the volunteers and connected to a CO 2 gas analyzer to measure CO 2 during the respiratory cycle. In phase 2, volunteers underwent a prolonged time of ventilation in CPAP 90 L/min and PSV with 20 L/min of bias flow. During free-flow CPAP, electrical impedance tomography was used to record the change in impedance during tidal breathing and then estimate tidal volume. Results: Ten healthy adults were enrolled in phase 1, and 8 volunteers in phase 2. CO 2 during inspiration was significantly lower in each setting with the two-limb versus the one-limb mask (p < 0.001). The maximum CO 2 reduction was observed in the continuous-flow CPAP settings. EtCO 2 was lower with the two-limb mask compared to the one-limb mask (p < 0.001). However, no difference in minute ventilation was observed between the two masks. Conclusion: The new mask design with two ports for inhaled and exhaled gases reduced the amount of CO 2 rebreathing in all tested ventilation settings. The CO 2 rebreathing reduction did not decrease minute ventilation in healthy volunteers.

BackgroundNon-invasive ventilation combined with pulmonary surfactant (PS) therapy is recognised as a method for treating neonatal respiratory distress syndrome (NRDS). Among the administration, methods of PS, INtubation–SURfactant–Extubation (InSurE) and less invasive surfactant administration (LISA) have been widely discussed.LISA technique prevents patients from exposure to invasive positive pressure ventilation (PPV), thus improving the long-term outcomes of the respiratory system, but it faces challenges in resource-limited areas due to complexity and cost. The InSurE technique remains prevalent due to its simplicity. The new dual-lumen tracheal tube (NDT) is designed with a 0.2 mm diameter pathway on the sidewall for continuous administration of PS under continuous PPV. The purpose of this study is to compare the safety and effectiveness of the NDT InSurE technique versus the LISA technique in non-invasive ventilation for premature infants with NRDS, and to explore the applicability of the NDT.Methods and analysisThis is a multicentre randomised controlled trial, planned to recruit 132 premature infants who meet the inclusion criteria from January 2024 to December 2024. They will be randomly assigned to the InSurE group using the NDT (experimental group) and the LISA group. The study will be conducted in six tertiary neonatal intensive care units in Yunnan province. The primary outcome is the rate of mechanical ventilation within 72 hours after birth. Secondary outcomes include the procedure data and major complications of NRDS, also include respiratory infections within 12 months of corrected age.DiscussionWe assume that the NDT is not worse than the LISA catheter. Based on the characteristics of the NDT, continuous PPV during drug administration, we designed this study to compare the InSurE technique using the NDT with the LISA technique. We aim to explore more benefits of the NDT and confirm wider clinical applicability. It will provide more options for doctors when using the InSurE technique.Ethics and disseminationThis study complies with the Declaration of Helsinki and was approved by the medical ethics committee of Kunming Children’s Hospital (approval number 2023-03-297-K01) and theoretical committee of Qujing Maternal and Child Health Hospital. At the end of the study, we will organise the data, complete the statistical analysis and present our research findings in the form of a paper.There is lack of comparative research on the NDT InSurE technique and LISA, making this study innovative. If the hypothesis is confirmed, clinicians will have an additional option when using PS, and it may even replace endotracheal tube in InSurE technique. The limited number of preterm infants planned for recruitment in the study may restrict stratified analyses based on gestational age, which could affect the broad applicability of the study results. The study is limited to preterm infants with a gestational age of less than 32 weeks, which means that the results may not be applicable to preterm infants with a larger gestational age or other patient populations.

Objective To compare the effect of heated, humidified, high-flow nasal cannula (HHHFNC) and nasal continuous positive airways pressure (NCPAP) on lung function and mechanics in preterm infants with respiratory distress syndrome (RDS) at the same level of retropharyngeal pressure (Prp). Design Randomised crossover trial. Setting Neonatal intensive care unit, Ospedale Maggiore Policlinico, Milan, Italy. Patients 20 preterm infants (gestational age: 31±1 wks) with mild-moderate RDS requiring non-invasive respiratory support within 96 h after birth. Interventions Infants were exposed to a randomised sequence of NCPAP and HHHFNC at different settings (2, 4 and 6 cmH2O for NCPAP and 2, 4, 6 L/min for HHHFNC) to enable comparison at the same level of Prp. Main outcome measures Tidal volume by respiratory inductance plethysmography, pleural pressure estimated by oesophageal pressure, and gas exchange were evaluated at each setting and used to compute breathing pattern parameters, lung mechanics and work of breathing (WOB). Results A poor linear regression between flow and Prp was found during HHHFNC (Prp=0.3+0.7*flow; r2=0.37). Only in 15 out of 20 infants it was possible to compare HHHFNC and NCPAP at a Prp of 2 and 4 cmH2O. No statistically significant differences were found in breathing pattern, gas exchange, lung mechanics and total WOB. Resistive WOB in the upper airways was slightly but significantly higher during HHHFNC (0.65 (0.49;1.09) vs 1.57 (0.85;2.09) cmH2O median (IQR)). Conclusions Despite differing mechanisms for generating positive airway pressure, when compared at the same Prp, NCPAP and HHHFNC provide similar effects on all the outcomes explored.

IntroductionThis study protocol describes a trial designed to investigate whether high-flow heated and humidified nasal oxygen (HFHO) therapy in patients with hypercapnic acute respiratory failure (ARF) reduces the need of non-invasive ventilation (NIV).Methods and analysisThis is an open-label, superiority, international, parallel-group, multicentre randomised controlled two-arm trial, with an internal feasibility pilot phase. 242 patients with hypercapnic ARF requiring NIV admitted to an intensive care unit, an intermediate care or a respiratory care unit will be randomised in a 1:1 ratio to receive HFHO or standard oxygen in between NIV sessions. Randomisation will be centralised and stratified by centre and pH at admission (pH ≤7.25 or >7.25). The primary outcome will be the number of ventilator-free days (VFDs) and alive at day 28 postrandomisation. The secondary outcomes will encompass parameters related to the VFDs, comfort and tolerance variables, hospital length of stay and mortality. VFDs at 28 days postrandomisation will be compared between the two groups by Wilcoxon-Mann-Whitney two-sample rank-sum test in the intention-to-treat population. A sensitivity analysis will be conducted in the population of patients for whom the criteria of switching from NIV to spontaneous breathing, or conversely, are not strictly verified.Ethics and disseminationThe protocol has been approved by the Comité de Protection des Personnes (CPP) Sud-Ouest & Outre-Mer IV (ref CPP17-049a/2017-A01830-53) and will be carried out in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. A trial steering committee will oversee the progress of the study. Findings will be disseminated through national and international scientific conferences, and publication in peer-reviewed journals.Trial registration number NCT03406572.

Heated, humidified, high-flow nasal cannula (HHHFNC) is increasingly being used, but there is a paucity of evidence as to the optimum flow rates in prematurely born infants. We have determined the impact of three flow rates on the work of breathing (WOB) assessed by transcutaneous diaphragm electromyography (EMG) amplitude in infants with respiratory distress or bronchopulmonary dysplasia (BPD). Flow rates of 4, 6 and 8 L/min were delivered in random order. The mean amplitude of the EMG trace and mean area under the EMG curve (AEMGC) were calculated and the occurrence of bradycardias and desaturations recorded. Eighteen infants were studied with a median gestational age of 27.8 (range 23.9–33.5) weeks and postnatal age of 54 (range 3–122) days. The median flow rate prior to the study was 5 (range 3–8) L/min and the fraction of inspired oxygen (FiO2) was 0.29 (range 0.21–0.50). There were no significant differences between the mean amplitude of the diaphragm EMG and the AEGMC and the number of bradycardias or desaturations between the three flow rates.Conclusions: In infants with respiratory distress or BPD, there was no advantage of using high (8 L/min) compared with lower flow rates (4 or 6 L/min) during support by HHHFNC.What is known:• Humidified high flow nasal cannulae (HHHFNC) is increasingly being used as a non-invasive form of respiratory support for prematurely born infants.• There is a paucity of evidence regarding the optimum flow rate with 1 to 8 L/min being used.What is new:• We have assessed the work of breathing using the amplitude of the electromyogram of the diaphragm at three HHHFNC flow rates in infants with respiratory distress or BPD.• No significant differences were found in the EMG amplitude results or the numbers of bradycardias or desaturations at 4, 6 and 8 L/min.