COVID-19 Acute Respiratory Distress Syndrome Clinical Trial
Official title:
Comparison for the Effect of Neuromuscular Blocking Agents Versus Sedation Alone on Severe ARDS Patients Due to COVID-19
Many questions about management of COVID-19 are still not answered. So, we recruit this study aiming to evaluate improvement of oxygenation in COVID-19 patients with severe ARDS, to improve morbidity and mortality of ICU covid patients, to participate in understanding of real hidden pathophysiology of COVID-19.
| Status | Not yet recruiting |
| Enrollment | 40 |
| Est. completion date | August 1, 2022 |
| Est. primary completion date | March 1, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | Inclusion Criteria: - Severe ARDS: PaO2/FiO2 <200, resistant hypoxemia and tachypnoea (RR > 40 breath/minute) - Not relieved by high frequency nasal canula or CPAP. - Need for invasive mechanical ventilation (uncooperative) Exclusion Criteria: - Patient relatives' refusal - Not mechanically ventilated. - Combination of female, corticosteroids administration and vecuronium muscle relaxant. - Neuromuscular diseases (especially demyelinating diseases). |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Assiut University |
Mason RJ. Pathogenesis of COVID-19 from a cell biology perspective. Eur Respir J. 2020 Apr 16;55(4). pii: 2000607. doi: 10.1183/13993003.00607-2020. Print 2020 Apr. — View Citation
Neto AS, Pereira VG, Espósito DC, Damasceno MC, Schultz MJ. Neuromuscular blocking agents in patients with acute respiratory distress syndrome: a summary of the current evidence from three randomized controlled trials. Ann Intensive Care. 2012 Jul 26;2(1) — View Citation
Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A, Jaber S, Arnal JM, Perez D, Seghboyan JM, Constantin JM, Courant P, Lefrant JY, Guérin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators. Neuromuscular blockers in early acute r — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | PaO2/FiO2 | ratio of arterial oxygen pressure in millilitre mercury to fraction of inspired oxygen at same time within the arterial blood gas | 48 hours | |
| Secondary | Change in lung mechanics | measurement of peak and plateau pressures in cm H2O, airway resistance in cm H2O. s/mL, static and dynamic compliance in Litre/cm H2O and positive end expiratory pressure in cm H2O from ventilator settings | 48 hours | |
| Secondary | SOFA score | Fulfilment of modified SOFA (Sepsis Organ Failure Assessment) score sheet | 48 hours | |
| Secondary | Measurement of tissue perfusion | Measurement of tissue perfusion by serum lactate in mmol/L and jugular venous oxygen saturation % from a sample withdrawn from CVP | 48 hours | |
| Secondary | Monitoring of Alveolar - Arterial Oxygen difference | An arterial canula is to be introduced and a quantity of 0.5 ml of blood samples are obtained from radial artery and arterial blood gas analysis are performed after anti-coagulation by heparin. Alveolar-arterial oxygen tension difference:
[P(A-a) DO2] = [(Pa-PH2O) × FiO2%-PaCO2-PaO2] [(760-47) × FiO2%-PaCO2-PaO2] [713 × FiO2%-PaCO2-PaO2] |
48 hours | |
| Secondary | 28 days survival | 28 days survival | after 28 days | |
| Secondary | Recording risk factors | Recording risk factors as diabetes, renal failure, immunosuppression, smoking, COPD and obesity | 28 days | |
| Secondary | Recording complications | Recording complications as VAP, HAP, neuromuscular weakness | 28 days |