Evaluation of Sedation in COVID-19 ARDS

NCT04667936 | Completed

• 1 other identifier: #20-643 -Sed II
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Critical Care; acute respiratory distress syndrome

Outcome Measures

Primary Outcomes (22)

• 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 Outcomes (2)

• Need for renal replacement therapy

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

• Need for extracorporeal membrane oxygenation (vvECMO)

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

Study Arms (1)

moderate to severe COVID-19 ARDS

patients with an oxygenation index \<200 under intubation anesthesia and mechanical ventilation.

Other: Treatment group

Interventions

Treatment group OTHER

None, solely treatment documentation

moderate to severe COVID-19 ARDS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• moderate to severe COVID-19 ARDS

You may not qualify if:

• None

Sponsors & Collaborators

• Goethe University: lead

Study Sites (1)

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Armin N Flinspach, MD

  KGU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 16, 2020
• Study Start: March 1, 2020
• Primary Completion: December 15, 2020
• Study Completion: April 1, 2021
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)