NCT05775029

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

May 5, 2022

Completed
11 months until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

March 7, 2025

Status Verified

March 1, 2025

Enrollment Period

3.1 years

First QC Date

May 5, 2022

Last Update Submit

March 4, 2025

Conditions

RSIRapid Sequence InductionComplication of AnesthesiaCompliant Behavior

Outcome Measures

Primary Outcomes (2)

  • Compliance to RSI guidelines

    3 years

  • Change in RSI complication

    3 years

Study Arms (2)

Study group 1

Short term compliance group

Study group 2

Long term compliance group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All staff members (specialist anaesthetist, nurse-anaesthetist, resident) performing RSI in adult patients.

You may qualify if:

  • All staff members (specialist anaesthetist, nurse-anaesthetist, resident anaesthetist) performing RSI in adult patients \>=18 years of age.

You may not qualify if:

  • Refusal of staff member to participate
  • RSI performed in patients \< 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Linköping University Hospital

Linköping, Östergötland County, 581 85, Sweden

Location

Vrinnevisjukhuset

Norrköping, Östergötland County, 60379, Sweden

Location

Related Publications (7)

  • 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.

    PMID: 5534675BACKGROUND

  • Zeuchner 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.

    PMID: 34173228BACKGROUND

  • 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.

    PMID: 32221099BACKGROUND

  • Jensen 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.

    PMID: 20701596BACKGROUND

  • Koerber 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.

    PMID: 19087008BACKGROUND

  • Pugel 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.

    PMID: 25731674BACKGROUND

  • Sullivan 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.

    PMID: 31723493BACKGROUND

MeSH Terms

Conditions

Cooperative Behavior

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Michelle Chew, M.D. Ph.D.

    Linkoeping University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 5, 2022

First Posted

March 20, 2023

Study Start

May 5, 2022

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

March 7, 2025

Record last verified: 2025-03

Locations

SE(2)