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Completed

NCT Number: NCT04667936

Evaluation of Sedation in COVID-19 ARDS

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.

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Key information

Conditions

Prone Position Hypnotics and Sedatives Lung Diseases Pulmonary Ventilation Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Severe Acute Respiratory Syndrome Coronavirus 2

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

moderate to severe COVID-19 ARDS

Exclusion criteria

None

Treatment and study plan

treatment group

Other

None, solely treatment documentation

Primary outcomes

  1. Position therapy

    Time frame: Data collection is performed at the date of death from any cause or discharge up to 10 weeks.

    Number of positioning therapys during treatment

  2. Agitation and sedation level

    Time frame: 30 minutes after study enrolment

    Measurement is performed using the Richmond Agitation and Sedation Scale (RASS, range: -5[Unarousable] to +4 [Combative], normal condition=0 [Alert and calm])

  3. Agitation and sedation level

    Time frame: 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])

  4. Application of opioid analgesic

    Time frame: 30 minutes after study enrolment

    Applied dosage of sufentanil (measured in µg/kg/h)

  5. Change of application of opioid analgesic

    Time frame: Change in average dosage within 8 hours.

    Applied dosage of sufentanil (measured in µg/kg/h)

  6. Application of opioid analgesic

    Time frame: 30 minutes after study enrolment

    Applied dosage of remifentanil (measured in µg/kg/min)

  7. Change of application of opioid analgesic

    Time frame: Change in average dosage within 8 hours.

    Applied dosage of remifentanil (measured in µg/kg/min)

  8. Application of sedative

    Time frame: 30 minutes after study enrolment

    Applied dosage of midazolam (measured in mg/kg/h)

  9. Change in sedative dosage applied

    Time frame: Change in average dosage within 8 hours.

    Applied dosage of midazolam (measured in mg/kg/h)

  10. Application of sedative

    Time frame: 30 minutes after study enrolment

    Applied dosage of propofol (measured in mg/kg/h)

  11. Change in sedative dosage applied

    Time frame: Change in average dosage within 8 hours.

    Applied dosage of propofol (measured in mg/kg/h)

  12. Application of sedative

    Time frame: 30 minutes after study enrolment

    Applied dosage of lormetazepam (measured in mg/kg/min)

  13. Change in sedative dosage applied

    Time frame: Change in average dosage within 8 hours.

    Applied dosage of lormetazepam (measured in mg/kg/min)

  14. Application of sedative

    Time frame: 30 minutes after study enrolment

    Applied dosage of clonidine (measured in µg/kg/h)

  15. Change in sedative dosage applied

    Time frame: Change in average dosage within 8 hours.

    Applied dosage of clonidine (measured in µg/kg/h)

  16. Application of sedative

    Time frame: 30 minutes after study enrolment

    Applied dosage of Dexmethomidine (measured in µg/kg/h)

  17. Change in sedative dosage applied

    Time frame: Change in average dosage within 8 hours.

    Applied dosage of Dexmethomidine (measured in µg/kg/h)

  18. Application of sedative

    Time frame: 30 minutes after study enrolment

    Applied dosage of esketamine (measured in mg/kg/h)

  19. Change in sedative dosage applied

    Time frame: Change in average dosage within 8 hours.

    Applied dosage of esketamine (measured in mg/kg/h)

  20. Patient Characteristics

    Time frame: The data is recorded at the time of enrolment

    Age (in years)

  21. Patient Characteristics

    Time frame: The data is recorded at the time of enrolment

    Height (in centimeters)

  22. Patient Characteristics

    Time frame: The data is recorded at the time of enrolment

    Weight (in kilograms)

Secondary outcomes

  1. Need for renal replacement therapy

    Time frame: 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

  2. Need for extracorporeal membrane oxygenation (vvECMO)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Dec 16, 2020
Registry last updated
Jul 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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