RSINCT05775029
RSI Observation Follow-up
An observational study of RSI and Rapid Sequence Induction, run by Jakob Zeuchner at 2 sites in Sweden.
Trial summary
The purpose of this prospective observational study is to determine if compliance to local guildelines for the RSI procedure, after introduction of a RSI-check list, persists over time (36-60months). Any changes in complication rates will also be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- RSI, Rapid Sequence Induction, Complication of Anesthesia
- How many people
- 2,300 participants
- Where
- 2 sitesSweden
- Study dates
- 5 May 2022to 31 Dec 2025
- 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: All staff members (specialist anaesthetist, nurse-anaesthetist, resident) performing RSI in adult patients.
Who may be able to join
- All staff members (specialist anaesthetist, nurse-anaesthetist, resident anaesthetist) performing RSI in adult patients >=18 years of age.
Who cannot join
- Refusal of staff member to participate
- RSI performed in patients < 18 years old.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Linköping University Hospital
Linköping, Östergötland County, 581 85
Vrinnevisjukhuset
Norrköping, Östergötland County, 60379
About this study
Official title: Rapid Sequence Induction Checklist and Its Effect on Compliance to Guidelines and Complications - Follow-up
The purpose of this prospective observational study is to determine if compliance to local guildelines for the RSI procedure, after introduction of a RSI-check list, persists over time (36-60months). Any changes in complication rates will also be evaluated.
Read the detailed description
A prospective observational study of long-term compliance to local RSI guidelines performed at two hospitals in Region Östergötland County, Sweden. All staff members (specialist anaesthetist, nurse-anaesthetist, resident anaesthetist) performing RSI in adult patients >=18 years of age are eligible for inclusion. Exclusion criteria are refusal to participate, or RSI performed in patients < 18 years old. All members of the staff at the participating centres will be given oral and written information about the study, and consent is implied by completion of the questionnaire.
A standard RSI checklist was introduced in the two hospitals during 2017-2018. The checklist is a 16-item document consisting of statements requiring binary yes/no and "check" type answers and was designed to encourage consistency and completeness in RSI preparations and execution. The statements were based on prior data in literature regarding the RSI procedure. Initial compliance was good when measured at 12 months after implementation of the RSI-checklist and a supporting educational program (Reference 1[Study results]).
The investigators plan to evaluate the long-term compliance to the RSI-checklist. Nurse anaesthetists or anaesthetists attending the patient during RSI will complete a predefined questionnaire about the conduct of RSI and RSI-related complications. The questionnaire will be completed immediately after induction when the patient is stable.
The investigators plan to conduct duplicate measurements in 20% of the observations to test inter-rater variability and to mitigate the risk of bias due to self-reporting.
Primary hypothesis: Compliance to local RSI-guidelines is maintained 36 months after introduction of a pre-RSI checklist.
Secondary hypothesis: Increased compliance to local RSI-guidelines 36 months after introduction of a pre-RSI checklist reduces the frequency of complications
Outcome:
Primary outcome: Compliance to local RSI-guidelines
Compliance categories were defined by consensus of the authors and individual parameters were not weighted. It is measured as a 7-point score, one point for the fulfilment of each seven parameters:
- 100% FiO2 with FGF >10 L/min for >3 minutes
- Use of Thiopental or Ketamine
- Use of Succinylcholine
- Use of an Orogastric tube
- Use of a stylet in the endotracheal tube
- Administration of Sodium Citrate
- Reverse Trendelenburg or supine patient position
Secondary outcome: Frequency of complications during RSI
Complications are defined as (according to the Swedish Perioperative Registry):
A111: Unexpected difficult airway; > 2 unsuccessful attempts to intubate the patient by an experienced anesthesiologist OR intubation by another, more experienced anesthesiologist than the anesthesiologist responsible for induction.
A126: Hypoxia that requires intervention, e.g. increased fiO2; Hypoxia SpO2 < 90%.
A215: Bradycardia that requires specific pharmacological intervention or change in anesthetic strategy A222: Hypotension that requires unplanned, continuous administration of vasopressor drug.
A514: Dental injury.
- Medical subject headings
- Cooperative Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group 1 | Short term compliance group | |
| Study group 2 | Long term compliance group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance to RSI guidelines
Measured: 3 years
Frequency of RSI complication
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start5 May 2022
- Primary completion1 Jun 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for RSIStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jakob Zeuchner
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Jakob Zeuchner, Linkoeping University
- Investigators
- Michelle Chew, M.D. Ph.D., Study director, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775029
- Sponsor's protocol ID
- 20220202
- Status last verified
- Oct 2026
- First submitted
- 5 May 2022
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stept WJ, Safar P. Rapid induction-intubation for prevention of gastric-content aspiration. Anesth Analg. 1970 Jul-Aug;49(4):633-6. No abstract available.
PubMed 5534675Klucka 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 32221099Jensen AG, Callesen T, Hagemo JS, Hreinsson K, Lund V, Nordmark J; Clinical Practice Committee of the Scandinavian Society of Anaesthesiology and Intensive Care Medicine. Scandinavian clinical practice guidelines on general anaesthesia for emergency situations. Acta Anaesthesiol Scand. 2010 Sep;54(8):922-50. doi: 10.1111/j.1399-6576.2010.02277.x.
PubMed 20701596Koerber JP, Roberts GE, Whitaker R, Thorpe CM. Variation in rapid sequence induction techniques: current practice in Wales. Anaesthesia. 2009 Jan;64(1):54-9. doi: 10.1111/j.1365-2044.2008.05681.x.
PubMed 19087008Pugel AE, Simianu VV, Flum DR, Patchen Dellinger E. Use of the surgical safety checklist to improve communication and reduce complications. J Infect Public Health. 2015 May-Jun;8(3):219-25. doi: 10.1016/j.jiph.2015.01.001. Epub 2015 Feb 26.
PubMed 25731674Sullivan A, Elshenawy S, Ades A, Sawyer T. Acquiring and Maintaining Technical Skills Using Simulation: Initial, Maintenance, Booster, and Refresher Training. Cureus. 2019 Sep 23;11(9):e5729. doi: 10.7759/cureus.5729.
PubMed 31723493Zeuchner J, Graf J, Elander L, Frisk J, Fredrikson M, Chew MS. Introduction of a rapid sequence induction checklist and its effect on compliance to guidelines and complications. Acta Anaesthesiol Scand. 2021 Oct;65(9):1205-1212. doi: 10.1111/aas.13947. Epub 2021 Jul 26.
PubMed 34173228
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Sequence Induction Checklist and Its Effect on Compliance to Guidelines and Complications - Follow-up
- ClinicalTrials.gov ID
- NCT05775029
- Acronym / sponsor ID
- 20220202
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,300 participants (actual)
- Lead sponsor
- Jakob ZeuchnerOther government
- Study start
- 5 May 2022 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 20 Mar 2023 (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.
The purpose of this prospective observational study is to determine if compliance to local guildelines for the RSI procedure, after introduction of a RSI-check list, persists over time (36-60months). Any changes in complication rates will also be evaluated.
Detailed description
A prospective observational study of long-term compliance to local RSI guidelines performed at two hospitals in Region Östergötland County, Sweden. All staff members (specialist anaesthetist, nurse-anaesthetist, resident anaesthetist) performing RSI in adult patients >=18 years of age are eligible for inclusion. Exclusion criteria are refusal to participate, or RSI performed in patients < 18 years old. All members of the staff at the participating centres will be given oral and written information about the study, and consent is implied by completion of the questionnaire.
A standard RSI checklist was introduced in the two hospitals during 2017-2018. The checklist is a 16-item document consisting of statements requiring binary yes/no and "check" type answers and was designed to encourage consistency and completeness in RSI preparations and execution. The statements were based on prior data in literature regarding the RSI procedure. Initial compliance was good when measured at 12 months after implementation of the RSI-checklist and a supporting educational program (Reference 1[Study results]).
The investigators plan to evaluate the long-term compliance to the RSI-checklist. Nurse anaesthetists or anaesthetists attending the patient during RSI will complete a predefined questionnaire about the conduct of RSI and RSI-related complications. The questionnaire will be completed immediately after induction when the patient is stable.
The investigators plan to conduct duplicate measurements in 20% of the observations to test inter-rater variability and to mitigate the risk of bias due to self-reporting.
Primary hypothesis: Compliance to local RSI-guidelines is maintained 36 months after introduction of a pre-RSI checklist.
Secondary hypothesis: Increased compliance to local RSI-guidelines 36 months after introduction of a pre-RSI checklist reduces the frequency of complications
Outcome:
Primary outcome: Compliance to local RSI-guidelines
Compliance categories were defined by consensus of the authors and individual parameters were not weighted. It is measured as a 7-point score, one point for the fulfilment of each seven parameters:
- 100% FiO2 with FGF >10 L/min for >3 minutes
- Use of Thiopental or Ketamine
- Use of Succinylcholine
- Use of an Orogastric tube
- Use of a stylet in the endotracheal tube
- Administration of Sodium Citrate
- Reverse Trendelenburg or supine patient position
Secondary outcome: Frequency of complications during RSI
Complications are defined as (according to the Swedish Perioperative Registry):
A111: Unexpected difficult airway; > 2 unsuccessful attempts to intubate the patient by an experienced anesthesiologist OR intubation by another, more experienced anesthesiologist than the anesthesiologist responsible for induction.
A126: Hypoxia that requires intervention, e.g. increased fiO2; Hypoxia SpO2 < 90%.
A215: Bradycardia that requires specific pharmacological intervention or change in anesthetic strategy A222: Hypotension that requires unplanned, continuous administration of vasopressor drug.
A514: Dental injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group 1 | – | –Short term compliance group |
| Study group 2 | – | –Long term compliance group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All staff members (specialist anaesthetist, nurse-anaesthetist, resident) performing RSI in adult patients.
Key inclusion criteria (1 listed)
- All staff members (specialist anaesthetist, nurse-anaesthetist, resident anaesthetist) performing RSI in adult patients >=18 years of age.
Key exclusion criteria (2 listed)
- Refusal of staff member to participate
- RSI performed in patients < 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compliance to RSI guidelines
Time frame: 3 years
Frequency of RSI complication
Time frame: 3 years
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 15 Oct 2026.
- Background: PubMed 5534675Stept WJ, Safar P. Rapid induction-intubation for prevention of gastric-content aspiration. Anesth Analg. 1970 Jul-Aug;49(4):633-6. No abstract available.
- Background: 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.
- Background: PubMed 20701596Jensen AG, Callesen T, Hagemo JS, Hreinsson K, Lund V, Nordmark J; Clinical Practice Committee of the Scandinavian Society of Anaesthesiology and Intensive Care Medicine. Scandinavian clinical practice guidelines on general anaesthesia for emergency situations. Acta Anaesthesiol Scand. 2010 Sep;54(8):922-50. doi: 10.1111/j.1399-6576.2010.02277.x.
- Background: PubMed 19087008Koerber JP, Roberts GE, Whitaker R, Thorpe CM. Variation in rapid sequence induction techniques: current practice in Wales. Anaesthesia. 2009 Jan;64(1):54-9. doi: 10.1111/j.1365-2044.2008.05681.x.
- Background: PubMed 25731674Pugel AE, Simianu VV, Flum DR, Patchen Dellinger E. Use of the surgical safety checklist to improve communication and reduce complications. J Infect Public Health. 2015 May-Jun;8(3):219-25. doi: 10.1016/j.jiph.2015.01.001. Epub 2015 Feb 26.
- Background: PubMed 31723493Sullivan A, Elshenawy S, Ades A, Sawyer T. Acquiring and Maintaining Technical Skills Using Simulation: Initial, Maintenance, Booster, and Refresher Training. Cureus. 2019 Sep 23;11(9):e5729. doi: 10.7759/cureus.5729.
- Results publication: PubMed 34173228Zeuchner J, Graf J, Elander L, Frisk J, Fredrikson M, Chew MS. Introduction of a rapid sequence induction checklist and its effect on compliance to guidelines and complications. Acta Anaesthesiol Scand. 2021 Oct;65(9):1205-1212. doi: 10.1111/aas.13947. Epub 2021 Jul 26.
- 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.
Michelle Chew, M.D. Ph.D. study director
Linkoeping University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of RSI and Rapid Sequence Induction, run by Jakob Zeuchner at 2 sites in Sweden.
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 2 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 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Compliance to RSI guidelines (time frame: 3 years). The study lists 2 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 NCT05775029, which also lists 7 linked publications.
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 15 Oct 2026.