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Respiratory Failure With Hypoxia clinical trials

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NCT ID: NCT04502576 Completed - Clinical trials for Respiratory Failure With Hypoxia

Helmet Noninvasive Ventilation vs. High-flow Nasal Cannula in Moderate-to-severe Acute Hypoxemic Respiratory Failure

HENIVOTpilot
Start date: October 13, 2020
Phase: N/A
Study type: Interventional

Helmet noninvasive ventilation and high-flow nasal cannula are novel tools for the first-line treatment of acute hypoxemic respiratory failure. Compared to face-mask noninvasive ventilation in randomized trials, both have improved clinical outcome of patients with moderate-to-severe hypoxemic respiratory failure. As compared to high-flow nasal cannula, helmet noninvasive ventilation improves oxygenation, reduces inspiratory effort, respiratory rate and dyspnea. Whether these physiological benefits are translated into improved outcome remains to be established. The investigators designed a randomized trial to establish whether first line treatment with Helmet noninvasive ventilation is capable of increasing the number of 28-day respiratory-support-free days, as compared to high-flow nasal cannula in patients with moderate-to-severe acute hypoxemic respiratory failure.

NCT ID: NCT04470258 Completed - COVID-19 Clinical Trials

Elmo Respiratory Support Project - COVID-19

Start date: June 25, 2020
Phase: N/A
Study type: Interventional

The number of COVID-19 cases has been growing exponentially, so that the industrialized economies are facing a significant shortage in the number of ventilators available to meet the demands imposed by the disease. Noninvasive ventilatory support can be valuable for certain patients, avoiding tracheal intubation and its complications. However, non-invasive techniques have a high potential to generate aerosols during their implementation, especially when masks are used in which it is virtually impossible to completely prevent air leakage and the dispersion of aerosols with viral particles. In this context, a helmet-like interface system with complete sealing and respiratory isolation of the patient's head can allow the application of ventilatory support without intubation and with safety and comfort for healthcare professionals and patients. This type of device is not accessible in Brazil, nor is it available for immediate import, requiring the development of a national product. Meanwhile, a task force under the coordination of the School of Public Health (ESP) and Fundação Cearense de Apoio à Pesquisa (FUNCAP), with support from SENAI / FIEC and the Federal Universities of Ceará (UFC) and the University of Fortaleza (UNIFOR) advanced in the development of a prototype and accessory system capable of providing airway pressurization through a helmet-type interface, which was called the Elmo System.

NCT ID: NCT04402320 Completed - Clinical trials for Respiratory Failure With Hypoxia

Non Invasive and Invasive Ventilation Post Extubation

Start date: April 10, 2019
Phase:
Study type: Observational [Patient Registry]

Patients and methods: It is a prospective double blind study done on total 300 patients. Admitted with respiratory failure ARDS due to severe lung contusion. All of them selected to be ventilated for one week or more. Patients were randomly allocated in one of three groups each group contain 100 patients. Group A considered control extubated and follow our routine protocol, patients of group B reconnected to mechanical ventilation before extubation for one hour. patients of Group C extubated and immediately connected to NIV with BIPAP mode for 1 hour every 12 hours for 24 hours. Results: There was significant reduction in the number of patients had deterioration in conscious level in all the duration of the study in patients of both groups B and C compared to group A. Also significant reduction in the number of patients had deterioration in clinical parameters of respiration in all the duration of the study in patients of both groups B and C compared to group A as regards high respiratory rate, desaturation and development of hyperdynamic circulation (tachycardia and hypertension). significant reduction in the number of patients had multiple quadrant parenchymatous infiltration in all the duration of the study in patients of both groups B and C compared to group A. significant reduction in the number of patients had marked limitation to FEV1, FVC and MVV in all the duration of the study in patients of both groups B and C compared to group A. Conclusion: Use of either NIV every 12 hours for 24 hours or MV for one hour after fulfillment of weaning criteria reduces reintubation and post-extubation respiratory failure and decrease the ICU stay in critically ill patients with resolving ARDS due to severe lung trauma.

NCT ID: NCT03095300 Completed - Clinical trials for Respiratory Failure With Hypoxia

Prone Positioning During High Flow Oxygen Therapy in Acute Hypoxemic Respiratory Failure

Optiprone
Start date: October 1, 2018
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03026322 Completed - Respiratory Failure Clinical Trials

Preventing Hypoxemia With Manual Ventilation During Endotracheal Intubation (PreVent) Trial

PreVent
Start date: March 15, 2017
Phase: N/A
Study type: Interventional

Complications are common during endotracheal intubation of critically ill adults. Manual ventilation between induction and intubation ("bag-valve-mask" ventilation) has been proposed as a means of preventing hypoxemia, the most common complication of intubation outside the operating room. Safety and efficacy data, however, are lacking. PreVent is a randomized trial comparing manual ventilation between induction and laryngoscopy to no manual ventilation between induction an laryngoscopy during endotracheal intubation of critically ill adults. The primary efficacy endpoint will be the lowest arterial oxygen saturation. The primary safety endpoints will be the lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end-expiratory pressure in the 24 hours after the procedure.