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There are 4 clinical trials
The prone position during mechanical ventilation in patients with Acute Respiratory Distress Syndrome (ARDS) is able to improve oxygenation and thus reduce mortality. The objective of the study is to evaluate the ability of the prone position to increase the oxygenation of the patient with SARS-cov-2 pneumonia.
Description: Measure the ability of the prone position to increase the oxygenation of the patient with SARS-cov-2 pneumonia as a lung recruitment index.Measure: Number of patients in whom the prone position caused an increase in oxygenation Time: Until patient discharge from the hospital (approximately 1 month after enrollment)
Description: Measure the feasibility of the prone position in terms of patient comfort and health resources in a context of a national health emergency.Measure: The feasibility of prone position Time: Until patient discharge from the hospital (approximately 1 month after enrollment)
Prone position (PP) has been proved to be effective in severe ARDS patients. On the other hand, High flow nasal cannula (HFNC) may prevent intubation in hypoxemic Acute respiratory failure (ARF) patients. Our hypothesis is that the combination of PP and HFNC in patients with COVID19 induced ARDS may decrease the need of mechanical ventilation. Primary outcome: Therapeutic failure within 28 days of randomization (death or intubation). Secondary outcomes: to analyze PP feasibility and safety in HFNC patients and to analyze effectiveness in terms of oxygenation. Methods: multicentric randomized study including patients with COVID19 induced ARDS supported with HFNC. Experimental group will received HFNC and PP whereas observation group will received standard care. Optimization of non-invasive respiratory management of COVID19 induced ARDS patients may decrease the need of invasive mechanical ventilation and subsequently ICU and hospital length of stay.
Description: Therapeutic failure: death or intubationMeasure: Therapeutic failure death or intubation Time: 28 days within randomization
Description: Comfort measurement using a visual-analog scale. Presence of complications related with prone position and the use of high-flow nasal cannula: Skin ulcers. Intravascular lines displacement HFNC related events (hot air feeling, nasal lesions)Measure: Feasibility and safety of prone position in HFNC patients Time: 28 days within randomization
Description: Evolution of the oxygenation (SpO2/FiO2) in prone position. Efficacy Length of HFNC therapy Length of ICU stay Length of mechanical ventilation (in those who require intubation) ICU and hospital mortalityMeasure: Efficacy of prone position in HFNC patients Time: 28 days within randomization
The prone position strategy for patients with acute respiratory distress syndrome (ARDS) is simple and cost-effective from the first description on its use in patients with acute respiratory failure to improve hypoxemia. Different studies have investigated its safety and efficacy in various clinical settings, demonstrating that its early use in combination with non-invasive mechanical ventilation (NIV) or high-flow oxygen therapy can reduce intubation rate and mortality in ARDS. In the Coronavirus disease 2019 (COVID-19) pandemic, high-value medicine and resource optimization are critical.
Description: Relationship between awake prone position and the tracheal intubationMeasure: To analyze the relationship between the prone position and the need for orotracheal intubation. Time: 3 months
Description: See the relationship between the awake prone position and the SaO2/FiO2 INDEXMeasure: The impact of the prone position on the partial oxygen saturation / inspired oxygen fraction index (SaO2 / FiO2). Time: 3 months
Description: Determine the free hours without the need for orotracheal intubation of patients in the prone position.Measure: Determine the free hours without the need for orotracheal intubation of patients in the prone position. Time: 3 months
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. Prone positioning (PP) is a recommended strategy for patients with moderate to severe acute respiratory distress syndrome (ARDS) undergoing invasive mechanical ventilation. Early PP combined with High Flow Oxygen Therapy may benefit spontaneous breathing patients with AHRF due to COVID-19 as recently reported in Jiangsu. Our hypothesis is that early PP combined with High Flow Oxygen Therapy in patients with AHRF due to COVID-19 improves oxygenation.
Description: Oxygenation will be evaluated by the [PaO2 / FiO2] ratio, measured at the beginning (baseline) and at the end of each 2h-sequence by arterial gasometry. The values of this ratio in PP and SP will be compared with each other.Measure: [PaO2 / FiO2] ratio Time: 6 hours
Description: ΔPeso (cm H2O): defined at each inspiratory cycle as the difference between the esophageal pressure at the end of expiration and at the end of inspiration.Measure: ΔPeso measured using an esophageal balloon catheter Time: 6 hours
Description: Capnometry measurements by breathing on a mouthpiece connected to an online analyzer. The measurements will be made on a 2 min recording (analysis of the curves over a period of 1 min) at the end of each sequence (PP or SP) and compared with each other.Measure: Concentration of CO2 at the end of expiration (EtCO2, mmHg) Time: 6 hours
Description: assessed by the visual analogue scale for dyspnea (collected at the beginning and at the end of each 2h sequence; the values at the end of each sequence will be compared with each other): 0 = no breathlessness to 10 = worst breathlessness possibleMeasure: Intensity of dyspnea Time: 6 hours
Description: measured by the visual analogue scale for pain (collected at the beginning and at the end of each 2h-sequence; the values at the end of each sequence will be compared with each other): 0 = no pain to 10 = worst pain possibleMeasure: Tolerance of the technique Time: 6 hours
Description: measured by the visual analogue scale for discomfort (collected at the beginning and at the end of each 2h-sequence; the values at the end of each sequence will be compared with each other): 0 = no discomfort to 10 = worst discomfort possibleMeasure: Tolerance of the technique Time: 6 hours
Description: Oxygen desaturation (SaO2 <90%), occurrence of hemodynamic instability (Systolic blood pressure <80 mmHg or heart rate >120 mmHg for >1 minute), accidental withdrawal of venous catheter central or peripheral, accidental withdrawal of arterial catheter, accidental withdrawal of urinary catheter.Measure: The occurrence of side effects due to PP Time: 6 hours
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports