Evidence-based Algorithm for the Expected Difficult Intubation

Airway Management Clinical Trial

— Expect-it  

Official title:

Development and Implementation of an Evidence-based Clinical Algorithm for the Expected Difficult Intubation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04863846
• Other study ID #: 2021-10459-BO-ff
• Status: Completed
• Start date: May 1, 2021
• Est. completion date: January 29, 2022

Study information

• Verified date: March 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Description:

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'.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1282
• Est. completion date: January 29, 2022
• Est. primary completion date: January 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing ENT or OMS surgery that require general anesthesia with tracheal intubation (either DL, VL or ATI)

• Age = 18 years

Exclusion Criteria:

• Denial of consent

• Planned intubation technique is not designated in the study protocol as it differs from either DL, VL, ATI (e.g. primary tracheotomy or rigid bronchoscopy)

Related Conditions & MeSH terms

• Airway Management
• Intubation, Intratracheal

Intervention

Other:
• No intervention, observational study
Exposure of interest: clinical implementation of an algorithm

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First phase: sensitivity and specificity (co-primary endpoints) of the clinical standard	Clinical assessment	3 months
Primary	Second phase: sensitivity and specificity (co-primary endpoints) of 'ATI recommendation' by the algorithm vs. 'VL/DL'	Clinical assessment	3 months
Primary	Second phase: sensitivity and specificity (co-primary endpoints) of 'DL recommendation' by the algorithm vs. 'VL/ATI'	Clinical assessment	3 months
Primary	Second phase: sensitivity and specificity (co-primary endpoints) of 'VL recommendation' by the algorithm vs. 'DL/ATI'	Clinical assessment	3 months
Secondary	Post-intubation recommendation for an intubation method	Recommendation of the responsible anesthetist	1 hour
Secondary	Post-intubation recommendation for an anesthesia alert card	Recommendation of the responsible anesthetist	1 hour
Secondary	Post-intubation diagnosis 'difficult intubation'	Rating of the responsible anesthetist	1 hour
Secondary	Post-intubation diagnosis 'difficult face-mask-ventilation'	Rating of the responsible anesthetist	1 hour
Secondary	Classification of intubation difficulty (VIDIAC classification)	Rating between -1 and 5 points	1 hour
Secondary	Best glottic view	Grading according to 'Percentage of Glottis Opening' (POGO)	1 hour
Secondary	Best glottic view	Grading according to the Cormack Lehane classification (I-IV)	1 hour
Secondary	First pass success rate	Percentage of successful intubations with one attempt	1 hour
Secondary	Overall success rate of the first choice technique	Percentage of successful intubation without transition to another technique	1 hour
Secondary	Number of attempts	Total number of attempts until airway established	1 hour
Secondary	Intubation time	Time to successful tracheal intubation	1 hour
Secondary	Lowest oxygen saturation	Measured with pulse oxymetry during anesthesia induction	1 hour
Secondary	Overall intubation difficulty, ease of intubation, quality of visualization	Subjective ratings on visual analogue scales (0 to 100 with 0 being the best)	1 hour
Secondary	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	1 hour
Secondary	Patient discomfort, satisfaction, symptoms	Clinical assessment during follow-up	12 hours
Secondary	Clinical evaluation of a core dataset 'anesthesia alert card'	Rating of various anesthetist	10 months
Secondary	Quality of care of the current clinical standard and the effects of algorithm implementation	Survey among anesthetist	7 months