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NCT05078034
This Randomized Control Trial will directly compare helmet non-invasive ventilation (NIV) combined with high flow nasal oxygen (HFNO) versus HFNO alone in patients with Acute Hypoxemic Respiratory Failure (AHRF).
NCT07452406
High-flow nasal cannula (HFNC) is a type of oxygen therapy commonly used in adults with breathing problems. While HFNC can help patients avoid breathing tubes and improve oxygen levels, there is no standard method for deciding how and when to reduce and stop this therapy once a patient improves. In many hospitals, these decisions vary from clinician to clinician. This study will compare usual care with a standardized step-by-step plan for reducing HFNC support. Eight hospitals will participate and will switch from usual care to the standardized plan at different time points during the study. The main goal is to determine whether the standardized weaning plan increases the number of patients who can successfully stop HFNC within 5 days. The study will also evaluate how long patients remain on HFNC, whether they need additional breathing support, and how long they stay in the hospital. The results may help develop clearer guidance for safely and efficiently stopping HFNC therapy.
NCT06210386
The optimal noninvasive management of acute hypoxemic respiratory failure is debated. Helmet noninvasive ventilation may be more effective than facemask noninvasive ventilation for these patients. Putatitve benefits of helmet use are the possibility to apply significantly higher positive end-expiratory pressure without air leaks and with good patient's comfort. In this randomized crossover study, the investigators will assess the physiological effects of helmet compared to facemask noninvasive ventilation, with the latter applied with different ventilator settings (similar to or different from helmet settings).
NCT06931938
Prone positioning has shown beneficial effects in intubated patients with severe respiratory failure and positive effects in awake patients with COVID-19 pneumonia. Conclusive evidence for patients with AHRF without COVID-19 is still missing. The investigators hypothesis that awake prone position in patients with AHRF is superior to standard supine/semi-recumbent position in terms of reducing the rate of tracheal intubation and/or all-cause death within 28 days after randomization.
NCT06938217
The current standard of care (SOC) for treatment of patients with acute respiratory distress syndrome (ARDS), inhalation injury, volume overload, and/or pulmonary dysfunction is mechanical ventilation (MV). However, these techniques are associated with several complications after prolonged use, including risk of infection, increased sedation requirements, pulmonary edema, ventilator-induced lung injury (VILI), barotrauma, and multi-organ failure. Extracorporeal life support (ECLS) has been used to successfully minimize, replace, or avoid the use of MV. This concept is critical as it permits ultra-lung protective MV settings, mobilization, early ambulation of patients, and timely extubation (when appropriate). Conventional ECLS typically requires blood flows of 3-6 L/min, and its cannula sizes range from 21-25 Fr. This is by definition "high-flow" as it constitutes near-complete extracorporeal circulation of patient's circulating blood volume. On the other hand, low-flow ECLS at 1-2.5 L/min has been shown to prevent deleterious shifts in pH and PaCO2 at a lower level of invasiveness, and its cannula sizes range from 19-20 Fr dual lumen cannulas (which are associated with less serial dilation). The investigators propose the use of a low-flow circuit to include the NovaLung system in conjunction with a smaller tubing set and cannula to enable earlier utilization of ECLS with less invasiveness and smaller catheters. Specifically, the study will either utilize the Crescent RA cannula (or equivalent dual-lumen cannula) or use a 15-25 Fr cannula, both with 3/8 tubing/step-down tubing, as needed, for our study. A femoral (fem)-femoral or femoral-internal jugular (IJ) approach may also be used. Carbon dioxide is six times more diffusible than oxygen across the membrane; thus, carbon dioxide transfers can occur with high efficiency at our targeted blood flows of 1-2.5L/min. Oxygen can still transfer at these blood flows, and low flow can improve oxygen levels to some degree. There are three benchtop-based manuscripts that suggest that low-flow ECMO is associated with a potential increase in factors that increase the risk of bleeding complications/circuit changes. However, the manuscripts either tested \<1 L/min blood flow rates, or the effect of cannula size was not considered. None of them included the biological component of endothelial interaction. Mitigating the risk of bleeding complications by will be completed by administering anticoagulants with a target PTT of 40-50 seconds, and by monitoring the patients and their coagulation panels closely. There may be less risk of circuit clotting in our study because of chosen flow rates (1-2.5 L/min).
NCT06007495
The goal of this pilot randomized cross-over study is to compare the effect of a full-face mask with expiratory washout to a conventional full face mask on non-invasive ventilation (NIV) in patients with acute hypercapnic, and acute hypoxemic, respiratory failure. The main questions it aims to answer are: * Does a mask with expiratory washout improve minute ventilation in patients using non-invasive ventilation compared with a conventional single-limb NIV mask * How does a mask with expiratory washout affect respiratory variables compared with a dual-limb NIV mask. Participants already prescribed NIV will undergo 3 arms of the investigation in a randomized order: * Single-limb NIV with investigation mask (with expiratory washout) * Single-limb NIV with conventional mask * Dual-limb NIV with conventional mask
NCT05465083
This is a single-center proof-of-concept clinical trial designed to establish the feasibility of transvenous phrenic-nerve stimulation (PNS) to maintain diaphragm activation over the first 24 hours and for up to seven days of mechanical ventilation in patients who are likely to require more than 48 hours of invasive mechanical ventilation.
NCT06096376
Ultrasound of the diaphragm is an easily reproducible bedside tool that provides a non-invasive measurement of inspiratory muscle function and respiratory efficiency. The diaphragmatic thickness correlates with the strength and muscle shortening and is reflective of its contribution to the respiratory workload. Diaphragm thickening fraction (DTF) has been shown to be predictive of extubation failure in ventilated patients. However, whether measurements of DTF are predictive of high flow nasal cannula (HFNC) outcomes in patients with acute hypoxemic respiratory failure (AHRF) remains unknown. The objective of this study is to identify predictors of HFNC failure by diaphragm ultrasound and to compare its performance with the well-established ROX index.
NCT06096363
Right ventricular dysfunction (RVD) and right ventricular-pulmonary arterial (RV-PA) uncoupling detected by transthoracic echocardiography (TTE) in acute respiratory distress syndrome (ARDS) are associated with poor survival. Early detection of RVD and RV-PA uncoupling in patients with acute hypoxemic respiratory failure (AHRF) may be indicative of worsening and decompensating pulmonary condition which may require escalation of respiratory support. The use of TTE parameters in predicting high-flow nasal cannula (HFNC) failure has not been previously studied. The objective of this study is to identify predictors of HFNC failure by TTE and to compare its performance with the well-established ROX index.
NCT04707729
Late or delayed intubation in patients with acute hypoxemic respiratory failure (AHRF) treated with nasal high flow (NHF) is associated with increased patient mortality. The ROX index has been designed and validated to predict outcome of NFH therapy by identifying those patients with a high risk of NHF failure and those with a high probability of success. Whether or not the ROX index may improve patient outcome remains to be shown. To do so, a strategy using the ROX index must lead to earlier intubation than commonly-used criteria. The objective of the ROX-1 trial is to assess whether the use of an algorithm incorporating the ROX index to standard of care for the time to intubation in patients with AHRF supported with NHF isassociated with an increase in the proportion of patients who are intubated within the first 12 hours among those patients who fail on NHF.
NCT04632043
Although management of acute hypoxemic respiratory failure associated with coronavirus disease 2019 (COVID-19) often includes mechanical ventilation, the optimal timing of initiation of invasive mechanical ventilation remains unknown. We hypothesise that a randomized controlled trial comparing early intubation as opposed to delayed intubation among patients with COVID-19 suffering from severe acute hypoxemic respiratory failure is feasible.
NCT03758508
The purpose of the study is to compare the efficacy of alternating Non Invasive Ventilation NIV and High Flow Oxygen HFO compared to High Flow Oxygen HFO alone on gas exchanges and prognosis in pneumonia-associated acute hypoxemic respiratory failure
NCT04570384
Prospective, Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Intravenous L-Citrulline (Turnobi) to Delay and Potentially Prevent the Need for Invasive Mechanical Ventilation for Acute Hypoxemic Respiratory Failure in Patients with COVID-19 (SARS-CoV2) Illness. To evaluate safety and efficacy of a bolus loading dose and continuous intravenous infusion of L-Citrulline compared to placebo in patients hospitalized with COVID-19 infection (SARS-CoV-2).
NCT04568642
During mechanical ventilation (MV) hypoxemic or hyperoxemic events should be carefully monitored and a quick response should be provided by the caregiver at the bedside. Pediatric mechanical ventilation consensus conference (PEMVECC) guidelines suggest to measure SpO2 in all ventilated children and furthermore to measure partial arterial oxygen pressure (PaO2) in moderate-to-severe disease. There were no predefined upper and lower limits for oxygenation in pediatric guidelines, however, Pediatric acute lung injury consensus conference PALICC guidelines proposed SpO2 between 92 - 97% when positive end-expiratory pressure (PEEP) is smaller than 10 cm H2O and SpO2 of 88 - 92% when PEEP is bigger or equal to 10 cm H2O. \[1\] For healthy lung, PEMVECC proposed the SpO2\>95% when breathing a FiO2 of 21%.\[2\] As a rule of thumb, the minimum fraction of inspired O2 (FiO2) to reach these targets should be used. A recent Meta-analyze showed that automated FiO2 adjustment provides a significant improvement of time in target saturations, reduces periods of hyperoxia, and severe hypoxia in preterm infants on positive pressure respiratory support. \[3\] This study aims to compare the closed-loop FiO2 controller with conventional control of FiO2 during mechanical ventilation of pediatric patients
NCT05499039
high flow nasal cannula (HFNC) oxygen therapy utilizes an air oxygen blend allowing from 21 % to 1 00% FiO2 delivery and generates up to 60 L/min flow rates The gas is heated and humidified through an active heated humidifier and delivered via a single limb heated inspiratory circuit (to avoid heat loss and condensation) to the patient through a large diameter nasal cannula Theoretically, HFNC offers significant advantages in oxygenation and ventilation over COT. Constant high flow oxygen delivery provides steady FiO2 and decreases oxygen dilution. It also washes out physiologic dead space and generates positive end expiration pressure (PEEP) that augments ventilation The heated humidification facilitates secretion clearance, decreases bronchospasm, and maintains mucosal integrity. This study aims to evaluate the effectiveness of HFNC compared to NIMV in management of Acute hypoxemic and acute hypercapneic respiratory failure
NCT05060926
Retrospective study in Sars-Cov 2 patients hospitalised in ICU. We aim to explore the effects of Awake prone positioning on oxygenation and intubation rate.
NCT04741659
Protective ventilation can be difficult to achieve during noninvasive ventilation for "de novo"acute hypoxemic respiratory failure (i.e., not due to exacerbation of chronic lung disease or cardiac failure).Recent data suggest patient self-inflicted lung injury (P-SILI) as a possible mechanism aggravating lung damage in these patients. The aim of this study is evaluate the tidal volume, measured by respiratory inductance plethysmography, in patients receiving different non invasive respiratory support.
NCT04395807
We aim to investigate whether the use of Continuous Positive Airway Pressure using a Helmet device (Helmet CPAP) will increase the number of days alive and free of ventilator within 28 days compared to the use of a High Flow Nasal Cannula (HFNC) in patients admitted to Helsingborg Hospital, Sweden, suffering from COVID-19 and an acute hypoxic respiratory failure.
NCT04344730
The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality. Two hypotheses will be tested in this study. The first hypothesis is the benefit of corticosteroid therapy on severe COVID-19 infection admitted in ICU in terms of survival. The second hypothesis is that, in the subset of patients free of mechanical ventilation at admission, either Continuous Positive Airway Pressure (CPAP) or High-Flow Nasal Oxygen (HFNO) allows to reduce intubation rate safely during COVID-19 related acute hypoxemic respiratory failure.
NCT00342368
Mechanical ventilation through an endotracheal tube is a lifesaving procedure for acute respiratory failure. However endotracheal intubation increases patient's discomfort and stress, and represents one of the most important predisposing factors for developing nosocomial bacterial pneumonia. In conscious and cooperative patients non invasive positive pressure ventilation (NPPV) is a safe and effective mean for treating patients with acute respiratory failure (ARF), improving gas exchanges and reducing the rate of complication related to mechanical ventilation. Facial mask, that is the conventional interface for NIV, may induce intolerance because of pain, discomfort or claustrophobia leading to discontinuation of noninvasive ventilation and endotracheal intubation. Thus the improvement of the interface between patient and ventilator seems crucial to achieve a good tolerance allowing the prolonged application of noninvasive ventilation. Attempting to improve tolerability of patients we used a new interface consisting in Helmet made in latex-free PVC. No prospective randomized controlled study has been published on the comparison between Continuous Positive Airways pressure (CPAP), delivered by an helmet and the medical treatment with Oxygen supplementation to treat early acute respiratory failure and acute lung injury. Aim of the present protocol is to compare the efficacy of CPAP delivered with helmet and conventional medical treatment with oxygen supplementation via Venturi mask, to prevent ETI in patients with early hypoxemic ARF ( paO2 /FiO2 below 300).