Evaluation of Sedation in COVID-19 ARDS

Severe Acute Respiratory Syndrome Coronavirus 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04667936
• Other study ID #: #20-643 -Sed II
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: June 2021
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: April 1, 2021
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

moderate to severe COVID-19 ARDS Exclusion Criteria: None

Related Conditions & MeSH terms

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

Intervention

Other:
• Treatment group
None, solely treatment documentation

Locations

Country	Name	City	State
Germany	University Hospital Frankfurt	Frankfurt	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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.
Primary	Application of opioid analgesic	Applied dosage of sufentanil (measured in µg/kg/h)	30 minutes after study enrolment
Primary	Change of application of opioid analgesic	Applied dosage of sufentanil (measured in µg/kg/h)	Change in average dosage within 8 hours.
Primary	Application of opioid analgesic	Applied dosage of remifentanil (measured in µg/kg/min)	30 minutes after study enrolment
Primary	Change of application of opioid analgesic	Applied dosage of remifentanil (measured in µg/kg/min)	Change in average dosage within 8 hours.
Primary	Application of sedative	Applied dosage of midazolam (measured in mg/kg/h)	30 minutes after study enrolment
Primary	Change in sedative dosage applied	Applied dosage of midazolam (measured in mg/kg/h)	Change in average dosage within 8 hours.
Primary	Application of sedative	Applied dosage of propofol (measured in mg/kg/h)	30 minutes after study enrolment
Primary	Change in sedative dosage applied	Applied dosage of propofol (measured in mg/kg/h)	Change in average dosage within 8 hours.
Primary	Application of sedative	Applied dosage of lormetazepam (measured in mg/kg/min)	30 minutes after study enrolment
Primary	Change in sedative dosage applied	Applied dosage of lormetazepam (measured in mg/kg/min)	Change in average dosage within 8 hours.
Primary	Application of sedative	Applied dosage of clonidine (measured in µg/kg/h)	30 minutes after study enrolment
Primary	Change in sedative dosage applied	Applied dosage of clonidine (measured in µg/kg/h)	Change in average dosage within 8 hours.
Primary	Application of sedative	Applied dosage of Dexmethomidine (measured in µg/kg/h)	30 minutes after study enrolment
Primary	Change in sedative dosage applied	Applied dosage of Dexmethomidine (measured in µg/kg/h)	Change in average dosage within 8 hours.
Primary	Application of sedative	Applied dosage of esketamine (measured in mg/kg/h)	30 minutes after study enrolment
Primary	Change in sedative dosage applied	Applied dosage of esketamine (measured in mg/kg/h)	Change in average dosage within 8 hours.
Primary	Patient Characteristics	Age (in years)	The data is recorded at the time of enrolment
Primary	Patient Characteristics	Height (in centimeters)	The data is recorded at the time of enrolment
Primary	Patient Characteristics	Weight (in kilograms)	The data is recorded at the time of enrolment
Secondary	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.
Secondary	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.