Evidence-based Algorithm for the Expected Difficult Intubation

NCT ID: NCT04863846

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1282 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-01-29

Brief 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).

Detailed 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'.

Conditions

Airway Management; Intubation, Intratracheal

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Clinical standard (first study phase)

Current clinical standard, non-algorithm-based decision-making (prior to implementation of the algorithm)

No intervention, observational study

Intervention Type: OTHER

Exposure of interest: clinical implementation of an algorithm

Algorithm-based allocation (second study phase)

New algorithm-based allocation to an intubation technique (after implementation of the algorithm)

No intervention, observational study

Intervention Type: OTHER

Exposure of interest: clinical implementation of an algorithm

Interventions

No intervention, observational study

Exposure of interest: clinical implementation of an algorithm

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Petzoldt, MD

Role: STUDY_CHAIR

Universitätsklinikum Hamburg-Eppendorf

Antonia Zapf, PhD

Role: STUDY_CHAIR

Universitätsklinikum Hamburg-Eppendorf

Christian Zöllner, MD

Role: STUDY_CHAIR

Universitätsklinikum Hamburg-Eppendorf

Locations

University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Countries

Germany

Other Identifiers

2021-10459-BO-ff

Identifier Type: -

Identifier Source: org_study_id