RSI Observation Follow-up

March 23, 2023 updated by: Jakob Zeuchner

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

3600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Study group 1
Short term compliance group
Study group 2
Long term compliance group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compliance to RSI guidelines
Time Frame: 3 years
3 years
Change in RSI complication
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jakob Zeuchner

Investigators

  • Study Director: Michelle Chew, M.D. Ph.D., Linkoeping University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2022

Primary Completion (Anticipated)

June 2, 2024

Study Completion (Anticipated)

October 2, 2024

Study Registration Dates

First Submitted

May 5, 2022

First Submitted That Met QC Criteria

March 7, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 20220202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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