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Evaluation of Sedation in COVID-19 ARDS

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04667936
Enrollment
114
Registered
2020-12-16
Start date
2020-03-01
Completion date
2021-04-01
Last updated
2021-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Critical Care, acute respiratory distress syndrome

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.

Interventions

OTHERTreatment group

None, solely treatment documentation

Sponsors

Goethe University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

moderate to severe COVID-19 ARDS

Exclusion criteria

None

Design outcomes

Primary

MeasureTime frameDescription
Patient CharacteristicsThe data is recorded at the time of enrolmentAge (in years)
Application of sedative30 minutes after study enrolmentApplied dosage of midazolam (measured in mg/kg/h)
Change in sedative dosage appliedChange in average dosage within 8 hours.Applied dosage of midazolam (measured in mg/kg/h)
Position therapyData 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 level30 minutes after study enrolmentMeasurement is performed using the Richmond Agitation and Sedation Scale (RASS, range: -5\[Unarousable\] to +4 \[Combative\], normal condition=0 \[Alert and calm\])
Application of opioid analgesic30 minutes after study enrolmentApplied dosage of sufentanil (measured in µg/kg/h)
Change of application of opioid analgesicChange in average dosage within 8 hours.Applied dosage of sufentanil (measured in µg/kg/h)

Secondary

MeasureTime frameDescription
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
Need for renal replacement therapyData 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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026