Evaluation of Sedation in COVID-19 ARDS

Evaluation of Impaired Sedation in Patients With Moderate to Severe 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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 114

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • University Hospital Frankfurt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all patients admitted to the intensive care unit who were already diagnosed with (SARS-CoV-2) infection.

Description

Inclusion Criteria:

moderate to severe COVID-19 ARDS

Exclusion Criteria:

None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
moderate to severe COVID-19 ARDS; patients with an oxygenation index <200 under intubation anesthesia and mechanical ventilation.	Other: Treatment group; None, solely treatment documentation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Goethe University
• Investigators: Principal Investigator: Armin N Flinspach, MD, KGU

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2020
• Primary Completion (ACTUAL): December 15, 2020
• Study Completion (ACTUAL): April 1, 2021

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: December 12, 2020
• First Posted (ACTUAL): December 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 28, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Critical Care; acute respiratory distress syndrome
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Severe Acute Respiratory Syndrome
• Other Study ID Numbers: #20-643 -Sed II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No