Comparison for the Effect of Neuromuscular Blocking Agents Versus Sedation Alone on Severe ARDS Patients Due to COVID-19
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Assiut University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- PaO2/FiO2
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Muscle relaxant group(group B)
They will receive muscle relaxation treatment for at least 48 hours. Cisatracurium will be given. Short term infusions up to 24 hours will be given in a dose rate of 2-3 mic/Kg/min followed by intervallic shots of 2-5 mg.
Intervention: muscle relaxation (Drug)
Outcomes
Primary Outcomes
PaO2/FiO2
Time Frame: 48 hours
ratio of arterial oxygen pressure in millilitre mercury to fraction of inspired oxygen at same time within the arterial blood gas
Secondary Outcomes
- Change in lung mechanics(48 hours)
- SOFA score(48 hours)
- Measurement of tissue perfusion(48 hours)
- 28 days survival(after 28 days)
- Recording risk factors(28 days)
- Monitoring of Alveolar - Arterial Oxygen difference(48 hours)
- Recording complications(28 days)
Investigators
Ayman Abd El-Khalek Mohammed Glala
Principle investigator
Assiut University