Evaluation of Sedation in COVID-19 ARDS

Completed

• Conditions: Pulmonary Ventilation; Prone Position; Severe Acute Respiratory Syndrome Coronavirus 2; Hypnotics and Sedatives
• Interventions: Other: Treatment group

• Registration Number: NCT04667936
• Lead Sponsor: Goethe University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2020-12-12
• Primary Completion: 2020-12-15
• Study First Posted: 2020-12-16
• Study Completion: 2021-04-01
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-28
• Last Update Posted: 2021-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

moderate to severe COVID-19 ARDS

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
moderate to severe COVID-19 ARDS	Treatment group	patients with an oxygenation index \<200 under intubation anesthesia and mechanical ventilation.

Primary Outcome Measures

Name	Time	Method
Position therapy	Data collection is performed at the date of death from any cause or discharge up to 10 weeks.	Number of positioning therapys during treatment
Agitation and sedation level	Change in average dosage within 8 hours.	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 sedative dosage applied	Change in average dosage within 8 hours.	Applied dosage of esketamine (measured in mg/kg/h)
Application of sedative	30 minutes after study enrolment	Applied dosage of esketamine (measured in mg/kg/h)
Application of opioid analgesic	30 minutes after study enrolment	Applied dosage of remifentanil (measured in µg/kg/min)
Patient Characteristics	The data is recorded at the time of enrolment	Weight (in kilograms)
Change of application of opioid analgesic	Change in average dosage within 8 hours.	Applied dosage of remifentanil (measured in µg/kg/min)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Frankfurt; 🇩🇪 Frankfurt, Hessen, Germany