Clinical trial NCT04667936: Evaluation of Sedation in COVID-19 ARDS
Official title: Evaluation of Impaired Sedation in Patients With Moderate to Severe COVID-19 ARDS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prone Position
Severe Acute Respiratory Syndrome Coronavirus 2
Hypnotics and Sedatives
Pulmonary Ventilation
Keywords: Critical Care
acute respiratory distress syndrome
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients admitted to the intensive care unit who were already diagnosed with (SARS-CoV-2) infection.

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.


Eligibility criteria: Inclusion Criteria:

moderate to severe COVID-19 ARDS

Exclusion Criteria:

None

Primary outcomes:
measure: Position therapy
timeFrame: Data collection is performed at the date of death from any cause or discharge up to 10 weeks.
measure: Agitation and sedation level
timeFrame: 30 minutes after study enrolment
measure: Agitation and sedation level
timeFrame: Change in average dosage within 8 hours.
measure: Application of opioid analgesic
timeFrame: 30 minutes after study enrolment
measure: Change of application of opioid analgesic
timeFrame: Change in average dosage within 8 hours.
measure: Application of opioid analgesic
timeFrame: 30 minutes after study enrolment
measure: Change of application of opioid analgesic
timeFrame: Change in average dosage within 8 hours.
measure: Application of sedative
timeFrame: 30 minutes after study enrolment
measure: Change in sedative dosage applied
timeFrame: Change in average dosage within 8 hours.
measure: Application of sedative
timeFrame: 30 minutes after study enrolment
measure: Change in sedative dosage applied
timeFrame: Change in average dosage within 8 hours.
measure: Application of sedative
timeFrame: 30 minutes after study enrolment
measure: Change in sedative dosage applied
timeFrame: Change in average dosage within 8 hours.
measure: Application of sedative
timeFrame: 30 minutes after study enrolment
measure: Change in sedative dosage applied
timeFrame: Change in average dosage within 8 hours.
measure: Application of sedative
timeFrame: 30 minutes after study enrolment
measure: Change in sedative dosage applied
timeFrame: Change in average dosage within 8 hours.
measure: Application of sedative
timeFrame: 30 minutes after study enrolment
measure: Change in sedative dosage applied
timeFrame: Change in average dosage within 8 hours.
measure: Patient Characteristics
timeFrame: The data is recorded at the time of enrolment
measure: Patient Characteristics
timeFrame: The data is recorded at the time of enrolment
measure: Patient Characteristics
timeFrame: The data is recorded at the time of enrolment
Secondary outcomes:
measure: Need for renal replacement therapy
timeFrame: Data collection is performed at the date of death from any cause or discharge up to 10 weeks.
measure: Need for extracorporeal membrane oxygenation (vvECMO)
timeFrame: Data collection is performed at the date of death from any cause or discharge up to 10 weeks.
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt
state: Hessen
Study officials:
affiliation: KGU
name: Armin N Flinspach, MD
role: PRINCIPAL_INVESTIGATOR
References: