Clinical trial NCT04922814: Comparison for the Effect of Neuromuscular Blocking Agents Versus Sedation Alone on Severe ARDS Patients Due to COVID-19
Official title: Comparison for the Effect of Neuromuscular Blocking Agents Versus Sedation Alone on Severe ARDS Patients Due to COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19 Acute Respiratory Distress Syndrome
Sedation Complication
ICU Acquired Weakness
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: PaO2/FiO2
timeFrame: 48 hours
Secondary outcomes:
measure: Change in lung mechanics
timeFrame: 48 hours
measure: SOFA score
timeFrame: 48 hours
measure: Measurement of tissue perfusion
timeFrame: 48 hours
measure: Monitoring of Alveolar - Arterial Oxygen difference
timeFrame: 48 hours
measure: 28 days survival
timeFrame: after 28 days
measure: Recording risk factors
timeFrame: 28 days
measure: Recording complications
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
References:
citation: Mason RJ. Pathogenesis of COVID-19 from a cell biology perspective. Eur Respir J. 2020 Apr 16;55(4):2000607. doi: 10.1183/13993003.00607-2020. Print 2020 Apr.
citation: Neto AS, Pereira VG, Esposito 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):33. doi: 10.1186/2110-5820-2-33.
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, Guerin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med. 2010 Sep 16;363(12):1107-16. doi: 10.1056/NEJMoa1005372.
citation: Hohmann F, Wedekind L, Grundeis F, Dickel S, Frank J, Golinski M, Griesel M, Grimm C, Herchenhahn C, Kramer A, Metzendorf MI, Moerer O, Olbrich N, Thieme V, Vieler A, Fichtner F, Burns J, Laudi S. Early spontaneous breathing for acute respiratory distress syndrome in individuals with COVID-19. Cochrane Database Syst Rev. 2022 Jun 29;6(6):CD015077. doi: 10.1002/14651858.CD015077.