NCT04863846

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,282

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2022

Completed
Last Updated

March 2, 2022

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

April 13, 2021

Last Update Submit

March 1, 2022

Conditions

Airway ManagementIntubation, Intratracheal

Keywords

LaryngoscopyLaryngoscopesDiagnostic Techniques, Respiratory System

Outcome Measures

Primary Outcomes (4)

  • First phase: sensitivity and specificity (co-primary endpoints) of the clinical standard

    Clinical assessment

    3 months

  • Second phase: sensitivity and specificity (co-primary endpoints) of 'ATI recommendation' by the algorithm vs. 'VL/DL'

    Clinical assessment

    3 months

  • Second phase: sensitivity and specificity (co-primary endpoints) of 'DL recommendation' by the algorithm vs. 'VL/ATI'

    Clinical assessment

    3 months

  • Second phase: sensitivity and specificity (co-primary endpoints) of 'VL recommendation' by the algorithm vs. 'DL/ATI'

    Clinical assessment

    3 months

Secondary Outcomes (17)

  • Post-intubation recommendation for an intubation method

    1 hour

  • Post-intubation recommendation for an anesthesia alert card

    1 hour

  • Post-intubation diagnosis 'difficult intubation'

    1 hour

  • Post-intubation diagnosis 'difficult face-mask-ventilation'

    1 hour

  • Classification of intubation difficulty (VIDIAC classification)

    1 hour

  • +12 more secondary outcomes

Study Arms (2)

Clinical standard (first study phase)

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

Other: No intervention, observational study

Algorithm-based allocation (second study phase)

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

Other: No intervention, observational study

Interventions

No intervention, observational studyOTHER

Exposure of interest: clinical implementation of an algorithm

Algorithm-based allocation (second study phase)Clinical standard (first study phase)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • Patients undergoing ENT or OMS surgery that require general anesthesia with tracheal intubation (either DL, VL or ATI)
  • Age ≥ 18 years

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Martin Petzoldt, MD

    Universitätsklinikum Hamburg-Eppendorf

    STUDY CHAIR

  • Antonia Zapf, PhD

    Universitätsklinikum Hamburg-Eppendorf

    STUDY CHAIR

  • Christian Zöllner, MD

    Universitätsklinikum Hamburg-Eppendorf

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2021

First Posted

April 28, 2021

Study Start

May 1, 2021

Primary Completion

January 29, 2022

Study Completion

January 29, 2022

Last Updated

March 2, 2022

Record last verified: 2022-03

Locations

DE(1)