Prone PositionNCT04667936
Evaluation of Sedation in COVID-19 ARDS
An observational study of Prone Position and Severe Acute Respiratory Syndrome Coronavirus 2, run by Goethe University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prone Position, Severe Acute Respiratory Syndrome Coronavirus 2, Hypnotics and Sedatives
- What is being tested?
- Treatment group
- How many people
- 114 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2020to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients admitted to the intensive care unit who were already diagnosed with (SARS-CoV-2) infection.
Who may be able to join
- moderate to severe COVID-19 ARDS
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Prone Position, Severe Acute Respiratory Syndrome Coronavirus 2, Hypnotics and Sedatives, Pulmonary Ventilation
- Being tested
- Treatment group
- Keywords
- Critical Care, acute respiratory distress syndrome
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment groupOther
None, solely treatment documentation
| Study group | Role | What they receive |
|---|---|---|
| moderate to severe COVID-19 ARDS | patients with an oxygenation index <200 under intubation anesthesia and mechanical ventilation. Receives: Other: Treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Position therapy
Number of positioning therapys during treatment
Measured: 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])
Measured: 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])
Measured: Change in average dosage within 8 hours.
Application of opioid analgesic
Applied dosage of sufentanil (measured in µg/kg/h)
Measured: 30 minutes after study enrolment
Change of application of opioid analgesic
Applied dosage of sufentanil (measured in µg/kg/h)
Measured: Change in average dosage within 8 hours.
Application of opioid analgesic
Applied dosage of remifentanil (measured in µg/kg/min)
Measured: 30 minutes after study enrolment
Change of application of opioid analgesic
Applied dosage of remifentanil (measured in µg/kg/min)
Measured: Change in average dosage within 8 hours.
Application of sedative
Applied dosage of midazolam (measured in mg/kg/h)
Measured: 30 minutes after study enrolment
Change in sedative dosage applied
Applied dosage of midazolam (measured in mg/kg/h)
Measured: Change in average dosage within 8 hours.
Application of sedative
Applied dosage of propofol (measured in mg/kg/h)
Measured: 30 minutes after study enrolment
Change in sedative dosage applied
Applied dosage of propofol (measured in mg/kg/h)
Measured: Change in average dosage within 8 hours.
Application of sedative
Applied dosage of lormetazepam (measured in mg/kg/min)
Measured: 30 minutes after study enrolment
Change in sedative dosage applied
Applied dosage of lormetazepam (measured in mg/kg/min)
Measured: Change in average dosage within 8 hours.
Application of sedative
Applied dosage of clonidine (measured in µg/kg/h)
Measured: 30 minutes after study enrolment
Change in sedative dosage applied
Applied dosage of clonidine (measured in µg/kg/h)
Measured: Change in average dosage within 8 hours.
Application of sedative
Applied dosage of Dexmethomidine (measured in µg/kg/h)
Measured: 30 minutes after study enrolment
Change in sedative dosage applied
Applied dosage of Dexmethomidine (measured in µg/kg/h)
Measured: Change in average dosage within 8 hours.
Application of sedative
Applied dosage of esketamine (measured in mg/kg/h)
Measured: 30 minutes after study enrolment
Change in sedative dosage applied
Applied dosage of esketamine (measured in mg/kg/h)
Measured: Change in average dosage within 8 hours.
Patient Characteristics
Age (in years)
Measured: The data is recorded at the time of enrolment
Patient Characteristics
Height (in centimeters)
Measured: The data is recorded at the time of enrolment
Patient Characteristics
Weight (in kilograms)
Measured: The data is recorded at the time of enrolment
Secondary outcomes (2)
Need for renal replacement therapy
The necessity and application of a renal replacement procedure is documented
Measured: 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
Measured: Data collection is performed at the date of death from any cause or discharge up to 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start1 Mar 2020
- Primary completion15 Dec 2020
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prone PositionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabeth H. Adam, Goethe University
- Investigators
- Armin N Flinspach, MD, Principal investigator, KGU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667936
- Sponsor's protocol ID
- #20-643 -Sed II
- Status last verified
- Jun 2021
- First submitted
- 25 Nov 2020
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Impaired Sedation in Patients With Moderate to Severe COVID-19 ARDS
- ClinicalTrials.gov ID
- NCT04667936
- Acronym / sponsor ID
- #20-643 -Sed II
- Conditions
- Prone Position, Severe Acute Respiratory Syndrome Coronavirus 2, Hypnotics and Sedatives, Pulmonary Ventilation
- Keywords
- Critical Care, acute respiratory distress syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 16 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| moderate to severe COVID-19 ARDS | – | Other: Treatment grouppatients with an oxygenation index <200 under intubation anesthesia and mechanical ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients admitted to the intensive care unit who were already diagnosed with (SARS-CoV-2) infection.
Key inclusion criteria (1 listed)
- moderate to severe COVID-19 ARDS
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment groupNone, solely treatment documentation | Other | moderate to severe COVID-19 ARDS |
Primary outcome
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
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])
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])
Application of opioid analgesic
Time frame: 30 minutes after study enrolment
Applied dosage of sufentanil (measured in µg/kg/h)
Change of application of opioid analgesic
Time frame: Change in average dosage within 8 hours.
Applied dosage of sufentanil (measured in µg/kg/h)
Application of opioid analgesic
Time frame: 30 minutes after study enrolment
Applied dosage of remifentanil (measured in µg/kg/min)
Change of application of opioid analgesic
Time frame: Change in average dosage within 8 hours.
Applied dosage of remifentanil (measured in µg/kg/min)
Application of sedative
Time frame: 30 minutes after study enrolment
Applied dosage of midazolam (measured in mg/kg/h)
Change in sedative dosage applied
Time frame: Change in average dosage within 8 hours.
Applied dosage of midazolam (measured in mg/kg/h)
Application of sedative
Time frame: 30 minutes after study enrolment
Applied dosage of propofol (measured in mg/kg/h)
Change in sedative dosage applied
Time frame: Change in average dosage within 8 hours.
Applied dosage of propofol (measured in mg/kg/h)
Application of sedative
Time frame: 30 minutes after study enrolment
Applied dosage of lormetazepam (measured in mg/kg/min)
Change in sedative dosage applied
Time frame: Change in average dosage within 8 hours.
Applied dosage of lormetazepam (measured in mg/kg/min)
Application of sedative
Time frame: 30 minutes after study enrolment
Applied dosage of clonidine (measured in µg/kg/h)
Change in sedative dosage applied
Time frame: Change in average dosage within 8 hours.
Applied dosage of clonidine (measured in µg/kg/h)
Application of sedative
Time frame: 30 minutes after study enrolment
Applied dosage of Dexmethomidine (measured in µg/kg/h)
Change in sedative dosage applied
Time frame: Change in average dosage within 8 hours.
Applied dosage of Dexmethomidine (measured in µg/kg/h)
Application of sedative
Time frame: 30 minutes after study enrolment
Applied dosage of esketamine (measured in mg/kg/h)
Change in sedative dosage applied
Time frame: Change in average dosage within 8 hours.
Applied dosage of esketamine (measured in mg/kg/h)
Patient Characteristics
Time frame: The data is recorded at the time of enrolment
Age (in years)
Patient Characteristics
Time frame: The data is recorded at the time of enrolment
Height (in centimeters)
Patient Characteristics
Time frame: The data is recorded at the time of enrolment
Weight (in kilograms)
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armin N Flinspach, MD principal investigator
KGU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prone Position and Severe Acute Respiratory Syndrome Coronavirus 2, run by Goethe University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Position therapy (time frame: Data collection is performed at the date of death from any cause or discharge up to 10 weeks.). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.