Rapid Sequence Induction and IntubationNCT05343702
Comparison of Standard rapi̇d Sequential Intubation Protocol With Rocuronium in Emergency Department
An observational study of Rapid Sequence Induction and Intubation and Rocuronium, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Airway management and advanced airway management are the issues that are applied every day in emergency services and that the emergency physician should know best. Rapid sequential intubation is one of the most frequently used techniques in advanced airway management. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rapid Sequence Induction and Intubation, Rocuronium
- What is being tested?
- priming with rocuronium
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2021to 15 Jan 2022
- How long will I take part?
- 1 Day
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Our study is a prospective, observational and randomized study conducted between 15.07.2021 and 01.12.2021 in Ankara City Hospital Emergency Medicine Clinic, which is a third-level emergency department with approximately 450,000 patient admissions per year. Patients who applied to the emergency department and needed rapid sequential intubation were included in our study.
Who may be able to join
- Be over the age of 18
- Need for advanced airway
- To give consent or consent to participate in the study consent of relatives of those who are unable to give
Who cannot join
- Have an indication of a crush (rescue) airway
- Have one of the difficult airway predictor Look, Evaluate, Obstruction, Neck mobility criteria
- maxillofacial anomaly or trauma
- detected during laryngoscopy with a cormack-lehane score of 3 and 4 patients
- Those who have inconveniences in applying ketamine to the clinic of the patient
- with a rocuronium or ketamine allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Standard rapi̇d Sequential Intubation Protocol With Rocuronium Priming Technique in Patients Registering to the Emergency Department and With Indication of Elective Intubation
Airway management and advanced airway management are the issues that are applied every day in emergency services and that the emergency physician should know best. Rapid sequential intubation is one of the most frequently used techniques in advanced airway management. However, anesthetic agents and paralytic agents have some concerns with some side effects. In our study, This study aimed to compare the effect of standard rapid sequential intubation protocol and application of rocuronium priming technique on the procedure time and hemodynamic profile.
Read the detailed description
This study is a prospective, observational and randomized study conducted between 15.07.2021 and 01.12.2021 in Ankara City Hospital Emergency Medicine Clinic, which is a third-level emergency department with approximately 450,000 patient admissions per year. Patients who applied to the emergency department and needed rapid sequential intubation were included in our study. Randomization was done according to the order of arrival of the cases. The demographic characteristics of the patients included in the study and the presence of diabetes mellitus were recorded. Routine rapid sequential intubation was performed in the standard group. In the priming group, 10% of the rocuronium dose was administered approximately 3 minutes before the induction agent. Intubation time, amount of drug used, vital signs before and after intubation, and end tidal carbon dioxide level to confirm intubation were recorded.
- Being tested
- priming with rocuronium
- Keywords
- Rapid Sequence Induction and Intubation, Rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
priming with rocuroniumDrug
Following induction (paralysis after onset of the induction effect) in routine rapid sequence intubation protocols While paralysis is applied, it is aimed to shorten the half-life of rocuronium by administering a subparalytic dose of rocuronium approximately 3-5 minutes before induction in the priming technique
| Study group | Role | What they receive |
|---|---|---|
| standard | standard rapid sequence intubation group (paralysis following induction) | |
| priming | group primed with rocuronium before induction Receives: Drug: priming with rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation time
when successful endotracheal intubation is performed after induction
Measured: ten minutes
blood pressure systolic and diastolic
mmhg
Measured: ten minutes
heart rate
beats/minute
Measured: ten minutes
Secondary outcomes (1)
indirect perfusion
Indirect tissue perfusion interpretation with endtidal carbon dioxide levels
Measured: ten minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start15 Jul 2021
- Primary completion1 Dec 2021
- Study completion15 Jan 2022
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 Induction and IntubationStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurullah İshak Işık, Ankara City Hospital Bilkent
- Investigators
- NURULLAH İSHAK IŞIK, M.D., Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343702
- Sponsor's protocol ID
- nısık
- Status last verified
- Sep 2023
- First submitted
- 8 Apr 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Isik NI, Ozhasenekler A, Yildirim C, Sener A, Kahraman FA, Gunaydin GP. Comparison of rocuronium priming vs. standard rapid sequence intubation technique in emergency department patients requiring intubation. Rev Assoc Med Bras (1992). 2024 Apr 22;70(3):e20231029. doi: 10.1590/1806-9282.20231029. eCollection 2024.
PubMed 38655998
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Standard rapi̇d Sequential Intubation Protocol With Rocuronium Priming Technique in Patients Registering to the Emergency Department and With Indication of Elective Intubation
- ClinicalTrials.gov ID
- NCT05343702
- Acronym / sponsor ID
- nısık
- Keywords
- Rapid Sequence Induction and Intubation, Rocuronium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 25 Apr 2022 (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.
Airway management and advanced airway management are the issues that are applied every day in emergency services and that the emergency physician should know best. Rapid sequential intubation is one of the most frequently used techniques in advanced airway management. However, anesthetic agents and paralytic agents have some concerns with some side effects. In our study, This study aimed to compare the effect of standard rapid sequential intubation protocol and application of rocuronium priming technique on the procedure time and hemodynamic profile.
Detailed description
This study is a prospective, observational and randomized study conducted between 15.07.2021 and 01.12.2021 in Ankara City Hospital Emergency Medicine Clinic, which is a third-level emergency department with approximately 450,000 patient admissions per year. Patients who applied to the emergency department and needed rapid sequential intubation were included in our study. Randomization was done according to the order of arrival of the cases. The demographic characteristics of the patients included in the study and the presence of diabetes mellitus were recorded. Routine rapid sequential intubation was performed in the standard group. In the priming group, 10% of the rocuronium dose was administered approximately 3 minutes before the induction agent. Intubation time, amount of drug used, vital signs before and after intubation, and end tidal carbon dioxide level to confirm intubation were recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard | – | –standard rapid sequence intubation group (paralysis following induction) |
| priming | – | Drug: priming with rocuroniumgroup primed with rocuronium before induction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Our study is a prospective, observational and randomized study conducted between 15.07.2021 and 01.12.2021 in Ankara City Hospital Emergency Medicine Clinic, which is a third-level emergency department with approximately 450,000 patient admissions per year. Patients who applied to the emergency department and needed rapid sequential intubation were included in our study.
Key inclusion criteria (3 listed)
- Be over the age of 18
- Need for advanced airway
- To give consent or consent to participate in the study consent of relatives of those who are unable to give
Key exclusion criteria (6 listed)
- Have an indication of a crush (rescue) airway
- Have one of the difficult airway predictor Look, Evaluate, Obstruction, Neck mobility criteria
- maxillofacial anomaly or trauma
- detected during laryngoscopy with a cormack-lehane score of 3 and 4 patients
- Those who have inconveniences in applying ketamine to the clinic of the patient
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 |
|---|---|---|
| priming with rocuroniumFollowing induction (paralysis after onset of the induction effect) in routine rapid sequence intubation protocols While paralysis is applied, it is aimed to shorten the half-life of rocuronium by administering a subparalytic dose of rocuronium approximately 3-5 minutes before induction in the priming technique | Drug | priming |
Primary outcome
intubation time
Time frame: ten minutes
when successful endotracheal intubation is performed after induction
blood pressure systolic and diastolic
Time frame: ten minutes
mmhg
heart rate
Time frame: ten minutes
beats/minute
1 secondary outcome
indirect perfusion
Time frame: ten minutes
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 28 Sep 2023.
- Derived from this study: PubMed 38655998Isik NI, Ozhasenekler A, Yildirim C, Sener A, Kahraman FA, Gunaydin GP. Comparison of rocuronium priming vs. standard rapid sequence intubation technique in emergency department patients requiring intubation. Rev Assoc Med Bras (1992). 2024 Apr 22;70(3):e20231029. doi: 10.1590/1806-9282.20231029. eCollection 2024.
- Individual participant dataSharing planned: Yes
Related trials for Rapid Sequence Induction and Intubation
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Comparison of High-Flow Nasal Cannula and Tight Face Mask for Maintaining Oxygenation During Rapid Sequence Induction
Hypoxemia, Airway Management
RecruitingObservational study
Pain Assessment During Rapid Sequence Induction
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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
RecruitingPhase 4
Comparison of Intubation Conditions During Rapid Sequence Induction Obtained With Modified Time Principal Induction With a Standard Intubation Dose of Rocuronium Versus Succinylcholine
Anesthesia
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.
NURULLAH İSHAK IŞIK, M.D. principal investigator
Ankara City Hospital Bilkent
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 and Intubation and Rocuronium, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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 28 Sep 2023. 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 Turkey (Türkiye). 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?
intubation time (time frame: ten minutes). The study lists 3 primary outcomes in all. 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 NCT05343702, 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 28 Sep 2023.