Rapid Sequence InductionRSICZNCT02985970
Rapid Sequence Induction Czech Republic: Survey
An observational study of Rapid Sequence Induction, run by Brno University Hospital.
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. Read more about this study
- Who is it for?
- Ages 4 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Rapid Sequence Induction
- What is being tested?
- questionnaire
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Apr 2017
- 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 4 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Anesthesiologists - members of the ČSARIM and www.akutne.cz
Who may be able to join
- all members of ČSARIM and www.akutne.cz
Who cannot join
- not members of ČSARIM and www.akutne.cz
About this study
Official title: Rapid Sequence Induction in Czech Republic: 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 Czech society of anesthesiology, resuscitation and intensive care (ČSARIM) members, the investigators bring 4 clinical scenarios in which RSI should be used. In the questionnaire the participants have to choose RSI or no and they have to describe all the next steps on anesthesia induction process in each single clinical scenario.
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 Czech society of anesthesiology, resuscitation and intensive care (ČSARIM) members, the investigators bring 4 clinical scenarios in which RSI should be used. In the questionnaire the participants have to choose RSI or no and they have to describe all the next steps on anesthesia induction process in each single clinical scenario.
- 1st. scenario - adult patient with acute abdomen in the OR to be anesthetized
- 2nd. scenario - 4 years old child with acute abdomen in the OR scheduled for an acute surgery
- 3rd. scenario - pregnant women scheduled for an elective caesarean section in the OR
- 4th. scenario - geriatric patient with hiatal hernia scheduled for an elective laparoscopic cholecystectomy.
In each scenario the several steps of the RSI sequence has to be answered:
Is RSI indicated? Y N
Peripheral vein line before induction? Y N
Nasogastric tube before/after induction or without?
Patients position: neutral, head-up, head-down?
Preoxygenation - 3/5minutes, breaths, (CPAP)/Positive end-expiratory pressure (PEEP)?
Sellick manoeuver? Y N
Drugs for induction (order with the number in the row) - propofol, etomidate, ketamine, thiopental, midazolam, suxamethonium, rocuronium, cisatracurium, atracurium, vecuronium
Manual hand-bag ventilation after induction: with limited pressure/contraindicated
Airway: tracheal tube with the cuff/without cuff/laryngeal mask
Comments
- 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 survey
The questionnaire will be send to all members of ČSARIM with the selected 4 controversial clinical scenarios in which the RSI should be used
| Study group | Role | What they receive |
|---|---|---|
| ČSARIM - questionnaire | Members of Czech society of anesthesiology, resuscitation and intensive care will obtain the questionnaire Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
RSI practice in Czech Republic - questionnaire
Evaluation of the clinical practice of the RSI in Czech Republic
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionFeb 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- 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
- NCT02985970
- Sponsor's protocol ID
- RSI 2016CZ
- Acronym
- RSICZ
- Status last verified
- Apr 2017
- First submitted
- 30 Nov 2016
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Sequence Induction in Czech Republic: Survey
- ClinicalTrials.gov ID
- NCT02985970
- Acronym / sponsor ID
- RSICZ / RSI 2016CZ
- Conditions
- Rapid Sequence Induction
- Keywords
- crush induction, RSI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 7 Dec 2016 (estimated)
- 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 Czech society of anesthesiology, resuscitation and intensive care (ČSARIM) members, the investigators bring 4 clinical scenarios in which RSI should be used. In the questionnaire the participants have to choose RSI or no and they have to describe all the next steps on anesthesia induction process in each single clinical scenario.
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 Czech society of anesthesiology, resuscitation and intensive care (ČSARIM) members, the investigators bring 4 clinical scenarios in which RSI should be used. In the questionnaire the participants have to choose RSI or no and they have to describe all the next steps on anesthesia induction process in each single clinical scenario.
- 1st. scenario - adult patient with acute abdomen in the OR to be anesthetized
- 2nd. scenario - 4 years old child with acute abdomen in the OR scheduled for an acute surgery
- 3rd. scenario - pregnant women scheduled for an elective caesarean section in the OR
- 4th. scenario - geriatric patient with hiatal hernia scheduled for an elective laparoscopic cholecystectomy.
In each scenario the several steps of the RSI sequence has to be answered:
Is RSI indicated? Y N
Peripheral vein line before induction? Y N
Nasogastric tube before/after induction or without?
Patients position: neutral, head-up, head-down?
Preoxygenation - 3/5minutes, breaths, (CPAP)/Positive end-expiratory pressure (PEEP)?
Sellick manoeuver? Y N
Drugs for induction (order with the number in the row) - propofol, etomidate, ketamine, thiopental, midazolam, suxamethonium, rocuronium, cisatracurium, atracurium, vecuronium
Manual hand-bag ventilation after induction: with limited pressure/contraindicated
Airway: tracheal tube with the cuff/without cuff/laryngeal mask
Comments
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ČSARIM - questionnaire | – | Other: questionnaireMembers of Czech society of anesthesiology, resuscitation and intensive care will obtain the questionnaire |
Who may qualify
- Ages
- 4 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Anesthesiologists - members of the ČSARIM and www.akutne.cz
Key inclusion criteria (1 listed)
- all members of ČSARIM and www.akutne.cz
Key exclusion criteria (1 listed)
- not members of ČSARIM and www.akutne.cz
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: surveyThe questionnaire will be send to all members of ČSARIM with the selected 4 controversial clinical scenarios in which the RSI should be used | Other | ČSARIM - questionnaire |
Primary outcome
RSI practice in Czech Republic - questionnaire
Time frame: one month
Evaluation of the clinical practice of the RSI in Czech Republic
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 24 Apr 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Rapid Sequence Induction
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Delayed Against Rapid Sequence Induction in Adults With Medical Diseases Undergoing Emergency Endotracheal Intubation.
Intubation in Intensive Care Units
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Comparison of High-Flow Nasal Cannula and Tight Face Mask for Maintaining Oxygenation During Rapid Sequence Induction
Hypoxemia, Airway Management
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Pain Assessment During Rapid Sequence Induction
Rapide Sequence Induction, Tracheal Intubation
Not yet recruiting
Which Rapid Sequence Induction Technique Should be Used in Urgent Surgery in Children?
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Recruiting
Comparison of Peri-intubation Oxygenation Values and Complications in Patients Intubated With the Delayed Versus Rapid Sequence Intubation Protocols
Delayed Sequence Intubation, Rapid Sequence Induction and Intubation
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
Questions about this trial
What is this clinical trial studying?
An observational study of Rapid Sequence Induction, run by Brno University Hospital.
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 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Czech Republic - questionnaire (time frame: one month). 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 24 Apr 2017.