Clinical trial NCT05775029: RSI Observation Follow-up
Official title: Rapid Sequence Induction Checklist and Its Effect on Compliance to Guidelines and Complications - Follow-up
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: RSI
Rapid Sequence Induction
Complication of Anesthesia
Compliant Behavior
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2023-03-20
Enrollment: 2300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All staff members (specialist anaesthetist, nurse-anaesthetist, resident) performing RSI in adult patients.

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.

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:

1. 100% FiO2 with FGF \>10 L/min for \>3 minutes
2. Use of Thiopental or Ketamine
3. Use of Succinylcholine
4. Use of an Orogastric tube
5. Use of a stylet in the endotracheal tube
6. Administration of Sodium Citrate
7. 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Compliance to RSI guidelines
timeFrame: 3 years
measure: Change in RSI complication
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University Hospital
state: Östergötland
city: Norrköping
country: Sweden
facility: Vrinnevisjukhuset
state: Östergötland
Study officials:
affiliation: Linkoeping University
name: Michelle Chew, M.D. Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.