Airway ManagementExpect-itNCT04863846
Evidence-based Algorithm for the Expected Difficult Intubation
An observational study of Airway Management and Intubation, Intratracheal, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Management, Intubation, Intratracheal
- How many people
- 1,282 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2021to 29 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients undergoing ENT or OMS surgery that require general anesthesia with tracheal intubation (either DL, VL or ATI)
- Age ≥ 18 years
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Implementation of an Evidence-based Clinical Algorithm for the Expected Difficult Intubation
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).
Read the 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
- Being tested
- No intervention, observational study
- Keywords
- Laryngoscopy, Laryngoscopes, Diagnostic Techniques, Respiratory System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, observational studyOther
Exposure of interest: clinical implementation of an algorithm
| Study group | Role | What they receive |
|---|---|---|
| Clinical standard (first study phase) | Current clinical standard, non-algorithm-based decision-making (prior to implementation of the algorithm) Receives: Other: No intervention, observational study | |
| Algorithm-based allocation (second study phase) | New algorithm-based allocation to an intubation technique (after implementation of the algorithm) Receives: Other: No intervention, observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
First phase: sensitivity and specificity (co-primary endpoints) of the clinical standard
Clinical assessment
Measured: 3 months
Second phase: sensitivity and specificity (co-primary endpoints) of 'ATI recommendation' by the algorithm vs. 'VL/DL'
Clinical assessment
Measured: 3 months
Second phase: sensitivity and specificity (co-primary endpoints) of 'DL recommendation' by the algorithm vs. 'VL/ATI'
Clinical assessment
Measured: 3 months
Second phase: sensitivity and specificity (co-primary endpoints) of 'VL recommendation' by the algorithm vs. 'DL/ATI'
Clinical assessment
Measured: 3 months
Secondary outcomes (17)
Post-intubation recommendation for an intubation method
Recommendation of the responsible anesthetist
Measured: 1 hour
Post-intubation recommendation for an anesthesia alert card
Recommendation of the responsible anesthetist
Measured: 1 hour
Post-intubation diagnosis 'difficult intubation'
Rating of the responsible anesthetist
Measured: 1 hour
Post-intubation diagnosis 'difficult face-mask-ventilation'
Rating of the responsible anesthetist
Measured: 1 hour
Classification of intubation difficulty (VIDIAC classification)
Rating between -1 and 5 points
Measured: 1 hour
Best glottic view
Grading according to 'Percentage of Glottis Opening' (POGO)
Measured: 1 hour
Best glottic view
Grading according to the Cormack Lehane classification (I-IV)
Measured: 1 hour
First pass success rate
Percentage of successful intubations with one attempt
Measured: 1 hour
Overall success rate of the first choice technique
Percentage of successful intubation without transition to another technique
Measured: 1 hour
Number of attempts
Total number of attempts until airway established
Measured: 1 hour
Intubation time
Time to successful tracheal intubation
Measured: 1 hour
Lowest oxygen saturation
Measured with pulse oxymetry during anesthesia induction
Measured: 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)
Measured: 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
Measured: 1 hour
Patient discomfort, satisfaction, symptoms
Clinical assessment during follow-up
Measured: 12 hours
Clinical evaluation of a core dataset 'anesthesia alert card'
Rating of various anesthetist
Measured: 10 months
Quality of care of the current clinical standard and the effects of algorithm implementation
Survey among anesthetist
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 May 2021
- Primary completion29 Jan 2022
- Study completion29 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Petzoldt, MD, Study chair, Universitätsklinikum Hamburg-EppendorfAntonia Zapf, PhD, Study chair, Universitätsklinikum Hamburg-EppendorfChristian Zöllner, MD, Study chair, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863846
- Sponsor's protocol ID
- 2021-10459-BO-ff
- Acronym
- Expect-it
- Status last verified
- Mar 2022
- First submitted
- 13 Apr 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Implementation of an Evidence-based Clinical Algorithm for the Expected Difficult Intubation
- ClinicalTrials.gov ID
- NCT04863846
- Acronym / sponsor ID
- Expect-it / 2021-10459-BO-ff
- Conditions
- Airway Management, Intubation, Intratracheal
- Keywords
- Laryngoscopy, Laryngoscopes, Diagnostic Techniques, Respiratory System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,282 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 29 Jan 2022 (actual)
- Study completion
- 29 Jan 2022 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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'.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical standard (first study phase) | – | Other: No intervention, observational studyCurrent clinical standard, non-algorithm-based decision-making (prior to implementation of the algorithm) |
| Algorithm-based allocation (second study phase) | – | Other: No intervention, observational studyNew algorithm-based allocation to an intubation technique (after implementation of the algorithm) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients undergoing ENT or OMS surgery that require general anesthesia with tracheal intubation (either DL, VL or ATI)
- Age ≥ 18 years
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention, observational studyExposure of interest: clinical implementation of an algorithm | Other | Algorithm-based allocation (second study phase), Clinical standard (first study phase) |
Primary outcome
First phase: sensitivity and specificity (co-primary endpoints) of the clinical standard
Time frame: 3 months
Clinical assessment
Second phase: sensitivity and specificity (co-primary endpoints) of 'ATI recommendation' by the algorithm vs. 'VL/DL'
Time frame: 3 months
Clinical assessment
Second phase: sensitivity and specificity (co-primary endpoints) of 'DL recommendation' by the algorithm vs. 'VL/ATI'
Time frame: 3 months
Clinical assessment
Second phase: sensitivity and specificity (co-primary endpoints) of 'VL recommendation' by the algorithm vs. 'DL/ATI'
Time frame: 3 months
Clinical assessment
17 secondary outcomes
Post-intubation recommendation for an intubation method
Time frame: 1 hour
Post-intubation recommendation for an anesthesia alert card
Time frame: 1 hour
Post-intubation diagnosis 'difficult intubation'
Time frame: 1 hour
Post-intubation diagnosis 'difficult face-mask-ventilation'
Time frame: 1 hour
Classification of intubation difficulty (VIDIAC classification)
Time frame: 1 hour
Best glottic view
Time frame: 1 hour
Best glottic view
Time frame: 1 hour
First pass success rate
Time frame: 1 hour
Overall success rate of the first choice technique
Time frame: 1 hour
Number of attempts
Time frame: 1 hour
Intubation time
Time frame: 1 hour
Lowest oxygen saturation
Time frame: 1 hour
Overall intubation difficulty, ease of intubation, quality of visualization
Time frame: 1 hour
Airway-related adverse events
Time frame: 1 hour
Patient discomfort, satisfaction, symptoms
Time frame: 12 hours
Clinical evaluation of a core dataset 'anesthesia alert card'
Time frame: 10 months
Quality of care of the current clinical standard and the effects of algorithm implementation
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Petzoldt, MD study chair
Universitätsklinikum Hamburg-Eppendorf
Antonia Zapf, PhD study chair
Universitätsklinikum Hamburg-Eppendorf
Christian Zöllner, MD study chair
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Management and Intubation, Intratracheal, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First phase: sensitivity and specificity (co-primary endpoints) of the clinical standard (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.