Comparison for the Effect of Neuromuscular Blocking Agents Versus Sedation Alone on Severe ARDS Patients Due to COVID-19

Assiut University40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

COVID-19 Acute Respiratory Distress Syndrome Sedation Complication ICU Acquired Weakness

Interventions

muscle relaxationDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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).

Locations (1)

Assiut university, faculty of medicine, anesthesia and ICU and pain management department

Asyut, Asyut Governorate, Egypt

Outcomes

Primary Outcomes

PaO2/FiO2

ratio of arterial oxygen pressure in millilitre mercury to fraction of inspired oxygen at same time within the arterial blood gas

Time frame: 48 hours

Secondary Outcomes

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

Time frame: 48 hours

SOFA score

Fulfilment of modified SOFA (Sepsis Organ Failure Assessment) score sheet

Time frame: 48 hours

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Measurement of tissue perfusion by serum lactate in mmol/L and jugular venous oxygen saturation % from a sample withdrawn from CVP

Time frame: 48 hours

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: \[P(A-a) DO2\] = \[(Pa-PH2O) × FiO2%-PaCO2-PaO2\] * \[(760-47) × FiO2%-PaCO2-PaO2\] * \[713 × FiO2%-PaCO2-PaO2\]

Time frame: 48 hours

28 days survival

Time frame: after 28 days

Recording risk factors

Recording risk factors as diabetes, renal failure, immunosuppression, smoking, COPD and obesity

Data from ClinicalTrials.gov

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