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

• Sponsor: Assiut University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04922814
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Anticipated Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Acute Respiratory Distress Syndrome; Sedation Complication; ICU Acquired Weakness	Drug: muscle relaxation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Comparison for the Effect of Neuromuscular Blocking Agents Versus Sedation Alone on Severe ARDS Patients Due to COVID-19
• Anticipated Study Start Date: Aug 1, 2021
• Anticipated Primary Completion Date: Mar 1, 2022
• Anticipated Study Completion Date: Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control group(group A) Only sedation for mechanically ventilated COVID patients
Experimental: 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.	Drug: muscle relaxation; 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.

Outcome Measures

Primary Outcome Measures

1. PaO2/FiO2 [48 hours]

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

Secondary Outcome Measures

1. Change in lung mechanics [48 hours]

   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

2. SOFA score [48 hours]

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

3. Measurement of tissue perfusion [48 hours]

   Measurement of tissue perfusion by serum lactate in mmol/L and jugular venous oxygen saturation % from a sample withdrawn from CVP

4. Monitoring of Alveolar - Arterial Oxygen difference [48 hours]

   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]

5. 28 days survival [after 28 days]

   28 days survival

6. Recording risk factors [28 days]

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

7. Recording complications [28 days]

   Recording complications as VAP, HAP, neuromuscular weakness

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: 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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ayman Abd El-Khalek Mohammed Glala, Principle investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT04922814
• Other Study ID Numbers: Covid-19 ICU
• First Posted: Jun 11, 2021
• Last Update Posted: Jun 11, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury

Study Results

No Results Posted as of Jun 11, 2021