Rapid Sequence InductionRSIEUNCT03694860
Rapid Sequence Induction EU: Electronic Survey (RSIEU)
An observational study of Rapid Sequence Induction, run by Brno University Hospital at 1 site in Czechia.
Trial summary
Rapid sequence induction (RSI) is a common part of routine anesthesiology practice. However several steps of RSI are not based on evidence based data (EBM) and are considered controversial. In an electronic evaluation form that will be send to European Society of Anaesthesiology (ESA) members. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Rapid Sequence Induction
- What is being tested?
- questionnaire
- How many people
- 1,921 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jul 2019to 1 Sep 2019
- 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 to 99 years
- All sexes
- Adult, Older adult
Study population: Members of Europen Society of Anaesthesiology
Who may be able to join
- Members of European Society of Anaesthesiology
Who cannot join
- not members of ESA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rapid Sequence Induction in EU: Electronic Survey
Rapid sequence induction (RSI) is a common part of routine anesthesiology practice. However several steps of RSI are not based on evidence based data (EBM) and are considered controversial. In an electronic evaluation form that will be send to European Society of Anaesthesiology (ESA) members. The electronic survey will contain 22 question (11 for adult RSI and 11 for paediatric RSI). In the questionnaire the participants will have to describe their routine clinical practice in performing rapid sequence induction.
Read the detailed description
Rapid sequence induction (RSI) is a common part of routine anesthesiology practice. However several steps of RSI are not based on evidence based data (EBM) and are considered controversial. In an electronic evaluation form that will be send to European Society of Anaesthesiology (ESA) members. The electronic survey will contain 22 question (11 for adult RSI and 11 for paediatric RSI). In the questionnaire the participants will have to describe their routine clinical practice in performing rapid sequence induction.
The 11 will be consulted with the research committee of ESA.
- Conditions
- Rapid Sequence Induction
- Being tested
- questionnaire
- Keywords
- crush induction, RSI
- Medical subject headings
- Cumulative Trauma Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Also called electronic survey
Members of European society of anaesthesiology care will obtain an electronic survey considering their clinical practice in RSI
What is being measured
The primary outcome is the main question the study is designed to answer.
RSI practice in European countries - questionnaire (electronic survey)
Evaluation of the clinical practice of the RSI European countries
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start1 Jul 2019
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rapid Sequence InductionStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,921 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Anaesthesiology
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Štourač, doc.MD.Ph.D, Study chair, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694860
- Sponsor's protocol ID
- RSI 2018 EU
- Acronym
- RSIEU
- Status last verified
- Sep 2019
- First submitted
- 2 Oct 2018
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Klucka J, Kosinova M, Zacharowski K, De Hert S, Kratochvil M, Toukalkova M, Stoudek R, Zelinkova H, Stourac P. Rapid sequence induction: An international survey. Eur J Anaesthesiol. 2020 Jun;37(6):435-442. doi: 10.1097/EJA.0000000000001194.
PubMed 32221099
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Sequence Induction in EU: Electronic Survey
- ClinicalTrials.gov ID
- NCT03694860
- Acronym / sponsor ID
- RSIEU / RSI 2018 EU
- Conditions
- Rapid Sequence Induction
- Keywords
- crush induction, RSI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,921 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- European Society of Anaesthesiology
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 3 Oct 2018 (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.
Rapid sequence induction (RSI) is a common part of routine anesthesiology practice. However several steps of RSI are not based on evidence based data (EBM) and are considered controversial. In an electronic evaluation form that will be send to European Society of Anaesthesiology (ESA) members. The electronic survey will contain 22 question (11 for adult RSI and 11 for paediatric RSI). In the questionnaire the participants will have to describe their routine clinical practice in performing rapid sequence induction.
Detailed description
Rapid sequence induction (RSI) is a common part of routine anesthesiology practice. However several steps of RSI are not based on evidence based data (EBM) and are considered controversial. In an electronic evaluation form that will be send to European Society of Anaesthesiology (ESA) members. The electronic survey will contain 22 question (11 for adult RSI and 11 for paediatric RSI). In the questionnaire the participants will have to describe their routine clinical practice in performing rapid sequence induction.
The 11 will be consulted with the research committee of ESA.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Members of Europen Society of Anaesthesiology
Key inclusion criteria (1 listed)
- Members of European Society of Anaesthesiology
Key exclusion criteria (1 listed)
- not members of ESA
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 |
|---|---|---|
| questionnaireAlso: electronic surveyMembers of European society of anaesthesiology care will obtain an electronic survey considering their clinical practice in RSI | Other | – |
Primary outcome
RSI practice in European countries - questionnaire (electronic survey)
Time frame: 2 months
Evaluation of the clinical practice of the RSI European countries
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 13 Sep 2019.
- Derived from this study: PubMed 32221099Klucka J, Kosinova M, Zacharowski K, De Hert S, Kratochvil M, Toukalkova M, Stoudek R, Zelinkova H, Stourac P. Rapid sequence induction: An international survey. Eur J Anaesthesiol. 2020 Jun;37(6):435-442. doi: 10.1097/EJA.0000000000001194.
- Individual participant dataSharing planned: Undecided
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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.
Petr Štourač, doc.MD.Ph.D study chair
Brno University Hospital
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 Rapid Sequence Induction, run by Brno University Hospital at 1 site in Czechia.
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 13 Sep 2019. 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 Czechia. 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?
RSI practice in European countries - questionnaire (electronic survey) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03694860, which also lists 1 linked publication.
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 13 Sep 2019.