Evaluation of Sedation in COVID-19 ARDS

Study Overview
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Brief Summary
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This study focuses on the evaluation of various factors repeatedly discussed in relation to the impaired sedation of intubated ventilated COVID-19 patients. The sedation response of >100 moderately to severely affected COVID-19 ARDS was evaluated. The sedation level was measured at the bedside using the Richmond Agitation and Sedation Scale and ventilator synchrony. The evaluation was performed according to the static evaluation plan with respect to age, storage therapy and organ failure.

Official Title
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Evaluation of Impaired Sedation in Patients With Moderate to Severe COVID-19 ARDS

Conditions
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Prone Position, Severe Acute Respiratory Syndrome Coronavirus 2, Hypnotics and Sedatives, Pulmonary Ventilation

Intervention / Treatment
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* Other: Treatment group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: moderate to severe COVID-19 ARDS Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| moderate to severe COVID-19 ARDS<br>patients with an oxygenation index <200 under intubation anesthesia and mechanical ventilation. | Other: Treatment group<br>* None, solely treatment documentation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Position therapy | Number of positioning therapys during treatment | Data collection is performed at the date of death from any cause or discharge up to 10 weeks. | 
| Agitation and sedation level | Measurement is performed using the Richmond Agitation and Sedation Scale (RASS, range: -5[Unarousable] to +4 [Combative], normal condition=0 [Alert and calm]) | 30 minutes after study enrolment | 
| Agitation and sedation level | Change of sedation level using the Richmond Agitation and Sedation Scale (RASS, range: -5[Unarousable] to +4 [Combative], normal condition=0 [Alert and calm]) | Change in average dosage within 8 hours. | 
| Application of opioid analgesic | Applied dosage of sufentanil (measured in µg/kg/h) | 30 minutes after study enrolment | 
| Change of application of opioid analgesic | Applied dosage of sufentanil (measured in µg/kg/h) | Change in average dosage within 8 hours. | 
| Application of opioid analgesic | Applied dosage of remifentanil (measured in µg/kg/min) | 30 minutes after study enrolment | 
| Change of application of opioid analgesic | Applied dosage of remifentanil (measured in µg/kg/min) | Change in average dosage within 8 hours. | 
| Application of sedative | Applied dosage of midazolam (measured in mg/kg/h) | 30 minutes after study enrolment | 
| Change in sedative dosage applied | Applied dosage of midazolam (measured in mg/kg/h) | Change in average dosage within 8 hours. | 
| Application of sedative | Applied dosage of propofol (measured in mg/kg/h) | 30 minutes after study enrolment | 
| Change in sedative dosage applied | Applied dosage of propofol (measured in mg/kg/h) | Change in average dosage within 8 hours. | 
| Application of sedative | Applied dosage of lormetazepam (measured in mg/kg/min) | 30 minutes after study enrolment | 
| Change in sedative dosage applied | Applied dosage of lormetazepam (measured in mg/kg/min) | Change in average dosage within 8 hours. | 
| Application of sedative | Applied dosage of clonidine (measured in µg/kg/h) | 30 minutes after study enrolment | 
| Change in sedative dosage applied | Applied dosage of clonidine (measured in µg/kg/h) | Change in average dosage within 8 hours. | 
| Application of sedative | Applied dosage of Dexmethomidine (measured in µg/kg/h) | 30 minutes after study enrolment | 
| Change in sedative dosage applied | Applied dosage of Dexmethomidine (measured in µg/kg/h) | Change in average dosage within 8 hours. | 
| Application of sedative | Applied dosage of esketamine (measured in mg/kg/h) | 30 minutes after study enrolment | 
| Change in sedative dosage applied | Applied dosage of esketamine (measured in mg/kg/h) | Change in average dosage within 8 hours. | 
| Patient Characteristics | Age (in years) | The data is recorded at the time of enrolment | 
| Patient Characteristics | Height (in centimeters) | The data is recorded at the time of enrolment | 
| Patient Characteristics | Weight (in kilograms) | The data is recorded at the time of enrolment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for renal replacement therapy | The necessity and application of a renal replacement procedure is documented | Data collection is performed at the date of death from any cause or discharge up to 10 weeks. | 
| Need for extracorporeal membrane oxygenation (vvECMO) | The necessity and application of an extracorporeal oxygenation procedure (ECMO) is documented | Data collection is performed at the date of death from any cause or discharge up to 10 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical Care, acute respiratory distress syndrome