Active clinical trials for "Respiratory Insufficiency"

The purpose of this two-year project is to pilot test an intervention to change sedation management in pediatric patients supported on mechanical ventilation for acute respiratory failure in the pediatric intensive care unit (PICU). While ensuring patient comfort is an integral part of pediatric critical care, analgesic and sedative use in this patient population is associated with injury; specifically, comfort medications may depress spontaneous ventilation and prolong the duration of mechanical ventilation. Additionally, drug tolerance develops over time and may precipitate iatrogenic abstinence syndrome (chemical withdrawal) when the patient no longer requires sedation. Alternatively, suboptimal comfort management contributes to the patient not breathing synchronously with the ventilator and/or self-removal of breathing tubes. Our group has developed and validated a nurse-implemented sedation algorithm (set of specific instructions) to guide titration of comfort medications that may optimize patient comfort and reduce the risk of under-medication, but this algorithm needs to be evaluated further. We hypothesize that pediatric patients managed per sedation protocol will experience fewer days of mechanical ventilation than patients receiving usual care. This research has the potential of revolutionizing sedation practices that are driven by and synchronized to patient needs.

Patients may be very agitated during the weaning period from mechanical ventilation. Administration of loxapine, a neuroleptic that does not notably affect ventilatory drive, may help in obtaining an adequate level of cooperation and, therefore, in reducing the duration of mechanical ventilation.

Protocol Summary: Question Does the adjunction of a humidification system to non-invasive ventilation circuit improve sleep quality and comfort of chronic ventilated respiratory insufficient patients? Does it change the efficacy of long-term non invasive ventilation therapy and patient-ventilator interactions? Aims Main aim: The primary endpoint of this study is to objectively evaluate the consequences of a humidification system's adjunction on quality of sleep, 2 months after treatment's beginning. Second aims: The secondary endpoints are to evaluate the consequences of a humidification system's adjunction on non invasive ventilation's efficacy / patient-ventilator asynchronies / patients' comfort / treatment adherence. Before the clinical trial, the investigators conducted a bench study using a mechanical lung in order to evaluate the ventilator's behavior with and without a humidification system. The clinical trial will include patients with chronic respiratory failure with an indication of long-term non invasive ventilation therapy. Patients will be included in the Pulmonology, Thoracic Oncology and Respiratory intensive care unit of Rouen University Hospital. It will be a prospective monocentric study, including consecutively all eligible patients. Informed consent will be obtained from all of them. At baseline, patients will be hospitalized for two consecutive nights for non invasive ventilation's set up. During the first night, a polysomnography will be performed without non invasive ventilation. Then, patients will be treated by non invasive ventilation with a bi-level self-regulated pressure mode and an open circuit. Patients will be randomized in two groups: without a humidification system and with a humidification system. Partitioning by the physiopathological pattern (obstructive versus obesity hypoventilation syndrome vs. neuromuscular disease) will be done. During each night, arterial blood gases will be measured at bedtime and awakening. Patients will be monitored by: polysomnography (only during the first night) transcutaneous capnography accessory inspiratory muscles surface electromyography pneumotachograph on non invasive ventilation's circuit pressions measured at the mask. Follow-up will take place at two months after non invasive ventilation's beginning with or without humidification. Patients will be hospitalized for one night only. Blood gases at bedtime and at awakening will be measured. A polysomnography with non invasive ventilation will be performed. Observance will be evaluated.

Mechanical ventilation can cause damage by overstretching the lungs, especially when the lungs are collapsed or edematous. Raising ventilator pressures can reduce lung collapse and this can prevent overstretching from mechanical ventilation. It remains uncertain how much pressure (PEEP - positive end-expiratory pressure) should be used on the ventilator and how to identify patients who will benefit from higher ventilator pressures vs. lower ventilator pressures. The investigators are using a unique new imaging technology, electrical impedance tomography (EIT), to study this problem and to determine the safest and most effective ventilator pressure level. The results of this study will inform future trials of higher vs. lower PEEP strategies in mechanically ventilated patients.

Background High-flow nasal cannula (NHF) are a promising tool for administering oxygen to critically ill patients with high respiratory demand. Prone positioning (PP) is a simple and cost-effective strategy that since 1980s has been used in mechanically ventilated patients with acute respiratory failure to treat oxygenation impairment. A large randomized study detected a relevant survival benefit by prone positioning in patients with moderate to severe acute respiratory distress syndrome (ARDS) undergoing invasive mechanical ventilation and managed with the ARDS network PEEP-FiO2 table strategy. Theoretically, PP may benefit spontaneous breathing patients too, but data concerning its application in such context are limited to small case series and a retrospective study. The investigators designed a pilot feasibility study to assess the safety and efficacy of prone positioning in acute hypoxemic respiratory failure patients noninvasively treated with NHF. Methods Patients: 15 adult hypoxemic (PaO2/FiO2<200 mmHg with respiratory rate greater than 25 breaths per minute) non-hypercapnic patients with acute respiratory failure. PaO2/FiO2 will be assessed while the patients is receiving 50 L/min of 50% oxygen via a standard face mask for a 15-minute monitoring period at study entry. Protocol Eligible patients will undergo NHF for 1 hour in the supine semi-recumbent position (baseline, BL). Afterwards, each enrolled patient will be placed in the prone position for 2 hours. After a 2-hour PP period, the patient will be rotated and will undergo 1 hour of NHF in the semi recumbent supine position (Supine step). Measurements Patient's demographics will be collected at study entry. At the end of the monitoring period, and then on a hourly basis the following data will be collected: Respiratory rate, SpO2, pH, PaCO2, PaO2, SaO2, PaO2/FiO2; Heart Rate, arterial blood pressure; Dyspnea, as defined by the VAS dyspnoea scale; Discomfort, as defined by a visual analogic scale (VAS) adapted to rate the procedural pain of ICU patients; End expiratory lung impedance (EELI), tidal volume distribution, global and regional lung dynamic strain (Change in lung impedence due to tidal volume/ELLI). Work of breathing, assessed by pressure-time product (PTP) of the esophageal pressure and inspiratory swings in this signal. Occurrence of pendelluft phenomenon The number of adverse events will be also recorded for each study step.

This is a pilot, multi-centre, open-label randomised controlled study to assess the early efficacy of intravenous (IV) administration of CYP-001 in adults admitted to an intensive care unit (ICU) with respiratory failure

In December 2019 in the city of Wuhan in China, a series of patients with unclear pneumonia was noticed, some of whom have died of it. In virological analyses of samples from the patients' deep respiratory tract, a novel coronavirus was isolated (SARS-CoV-2). The disease spread rapidly in the city of Wuhan at the beginning of 2020 and soon beyond in China and, in the coming weeks, around the world. Initial studies described numerous severe courses, particularly those associated with increased patient age and previous cardiovascular, metabolic and respiratory diseases. A small number of the particularly severely ill patients required not only highly invasive ventilation therapy but also extracorporeal membrane oxygenation (vv-ECMO) to supply the patient's blood with sufficient oxygen. Even under maximum intensive care treatment, a very high mortality rate of approximately 80-100% was observed in this patient group. In addition, high levels of interleukin-6 (IL-6) could be detected in the blood of these severely ill patients, which in turn were associated with poor outcome. From experience in the therapy of severely ill patients with severe infections and respiratory failure, we know that treatment with a CytoSorb® adsorber can lead to a reduction of the circulating pro- and anti-inflammatory cytokines and thus improve the course of the disease and the outcome of the patients. Our primary goal is to investigate the efficacy of treatment with a CytoSorb® adsorber in patients with severe COVID-19 disease requiring venous ECMO over 72 hours after initiation of ECMO. The primary endpoint is the reduction of plasma interleukin-6 levels 72 hours after initiation of ECMO support. As secondary endpoints we investigate 30-day survival, vasopressor and volume requirements, lactate in terms of lactate and platelet function. As safety variables, we further investigate the levels of the applied antibiotics (usually ampicillin and sulbactam).

Prospective multi-center phase 2b randomized placebo-controlled double-blinded interventional platform trial of two different pharmacologic therapies (intravenous Vitamin C or intravenous Acetaminophen) for patients with sepsis-induced hypotension or respiratory failure.

This is a placebo-controlled, double blind, randomized, Phase II dose escalation study intended to evaluate the potential safety and efficacy of tenecteplase for the treatment of COVID-19 associated respiratory failure. The hypothesis is that administration of the drug, in conjunction with heparin anticoagulation, will improve patients' clinical outcomes.

Study hypothesis: Non-invasive positive pressure ventilation delivered by helmet will reduce 28-day all-cause mortality in patients with suspected or confirmed severe COVID-19 pneumonia and acute hypoxemic respiratory failure