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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.
Full 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:
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.
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Inclusion criteria
• All staff members (specialist anaesthetist, nurse-anaesthetist, resident anaesthetist) performing RSI in adult patients >=18 years of age.
Exclusion criteria
2,300 participants in 2 patient groups
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Central trial contact
Jakob Zeuchner, M.D.; Martin Ingves, M.D.
Data sourced from clinicaltrials.gov
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