An observational study in Airway Management and Intubation, Intratracheal, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-02.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational
The Expect-it study aims to accompany the development and clinical implementation process of a new algorithm for the management of expected difficult intubation. The new algorithm is designed to allocate patients to specific tracheal intubation techniques. After assessing the status quo (non-algorithm-based decision-making) the new algorithm-based allocation will be compared with this clinical standard within a confirmatory diagnostic accuracy study (post-implementation).
Difficult tracheal intubation is one of the major reasons for anesthesia-related adverse events. Patients undergoing ear, nose \& throat (ENT) or oral and maxillofacial (OMS) surgery often require tracheal intubation for general anesthesia but are at increased risk for difficult tracheal intubation. Currently, existing preoperative tests for the prediction of difficult intubation show low diagnostic accuracy. Moreover, as the results of these prediction tests are not coupled with concrete treatment recommendations, they cannot be used targeted within preventive concepts. An evidence based rational algorithm for the management of expected difficult intubation has not been developed yet. It is unknown, if an algorithm-based allocation to an intubation approach might be advantageous compared with a non-algorithm-based allocation strategy.
The Expect-it study aims to accompany the development and clinical implementation process of a new algorithm for the management of expected difficult intubation. This new algorithm is designed to provide an evidence-based decision-making tool for a rational pre-choice of tracheal intubation techniques, anesthetized intubation by direct laryngoscopy (DL) or videolaryngoscopy (VL) or awake tracheal intubation (ATI). In the first study phase the status quo (clinical standard, non-algorithm-based decision-making) will be assessed (three-month period with an approximated case number of up to 600 patients). The Expect-it algorithm will be implemented thereafter. Between both study phases, the algorithm will be updated (based on the findings of the first phase), sensitivity and specificity of the clinical standard will be calculated, sample size will critically be appraised and readjusted (approximately 600 within at least three months), if appropriate. The second study phase is a confirmatory diagnostic accuracy study for the new algorithm with a single test study design, that aims to proof, if the new Expect-it algorithm is superior or at least non-inferior to the clinical standard, defined as superiority in either the specificity or sensitivity and non-inferiority in the other co-primary endpoint in each domain (ATI, DL, VL) (pre-planned preliminary analysis of the first study phase; IRB amendment 2021-10459_2-BO-ff, December 3, 2021). Sensitivity and specificity are considered co-primary endpoints. Study planning and conduction is in accordance with the Standards for Reporting Diagnostic accuracy studies (STARD) statement. The Expect-it study will further include two surveys among anesthetist in the study center in order to evaluate challenges and obstacles associated with the implementation process and possible clinical implications of the algorithm. An additional analysis will be performed to test a core data set for an 'anesthesia alert card'.
Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive sampling: Adult patients that undergo ENT or OMS surgery in a tertiary care hospital who require tracheal intubation and consent to participate within two predefined study periods of at least 3 months.
Exclusion Criteria:
Current clinical standard, non-algorithm-based decision-making (prior to implementation of the algorithm)
Other: No intervention, observational study
New algorithm-based allocation to an intubation technique (after implementation of the algorithm)
Other: No intervention, observational study
Exposure of interest: clinical implementation of an algorithm
First phase: sensitivity and specificity (co-primary endpoints) of the clinical standard
Clinical assessment
Time frame: 3 months
Second phase: sensitivity and specificity (co-primary endpoints) of 'ATI recommendation' by the algorithm vs. 'VL/DL'
Clinical assessment
Time frame: 3 months
Second phase: sensitivity and specificity (co-primary endpoints) of 'DL recommendation' by the algorithm vs. 'VL/ATI'
Clinical assessment
Time frame: 3 months
Second phase: sensitivity and specificity (co-primary endpoints) of 'VL recommendation' by the algorithm vs. 'DL/ATI'
Clinical assessment
Time frame: 3 months
Post-intubation recommendation for an intubation method
Recommendation of the responsible anesthetist
Time frame: 1 hour
Post-intubation recommendation for an anesthesia alert card
Recommendation of the responsible anesthetist
Time frame: 1 hour
Post-intubation diagnosis 'difficult intubation'
Rating of the responsible anesthetist
Time frame: 1 hour
Post-intubation diagnosis 'difficult face-mask-ventilation'
Rating of the responsible anesthetist
Time frame: 1 hour
Classification of intubation difficulty (VIDIAC classification)
Rating between -1 and 5 points
Time frame: 1 hour
Best glottic view
Grading according to 'Percentage of Glottis Opening' (POGO)
Time frame: 1 hour
Best glottic view
Grading according to the Cormack Lehane classification (I-IV)
Time frame: 1 hour
First pass success rate
Percentage of successful intubations with one attempt
Time frame: 1 hour
Overall success rate of the first choice technique
Percentage of successful intubation without transition to another technique
Time frame: 1 hour
Number of attempts
Total number of attempts until airway established
Time frame: 1 hour
Intubation time
Time to successful tracheal intubation
Time frame: 1 hour
Lowest oxygen saturation
Measured with pulse oxymetry during anesthesia induction
Time frame: 1 hour
Overall intubation difficulty, ease of intubation, quality of visualization
Subjective ratings on visual analogue scales (0 to 100 with 0 being the best)
Time frame: 1 hour
Airway-related adverse events
Laryngospasm, bronchospasm, larynx trauma, airway trauma, soft tissue trauma, oral bleeding, edema, dental damage, corticosteroid application, accidental esophageal intubation, aspiration, hypotension or hypoxia
Time frame: 1 hour
Patient discomfort, satisfaction, symptoms
Clinical assessment during follow-up
Time frame: 12 hours
Clinical evaluation of a core dataset 'anesthesia alert card'
Rating of various anesthetist
Time frame: 10 months
Quality of care of the current clinical standard and the effects of algorithm implementation
Survey among anesthetist
Time frame: 7 months
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Universitätsklinikum Hamburg-Eppendorf