IntubationNCT06815952
Enhancing Difficult Laryngoscopy Prediction Through A Mixed Scoring System
An observational study of Intubation and Laryngoscopy, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
This study aims to develop a comprehensive airway assessment score including traditional bedside clinical tests and ultrasound measurements with high accuracy in predicting difficult airway, and to validate it through testing it on a large population sample. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intubation, Laryngoscopy, Anesthesia
- How many people
- 1,100 participants
- Where
- 1 siteLebanon
- Study dates
- 20 Feb 2025to 1 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients undergoing general anesthesia, American Society of Anesthesiologists (ASA) classification, emergency or elective cases.
Who may be able to join
- Adult patients undergoing general anesthesia
- American Society of Anesthesiologists (ASA) classification 1-4
- Emergency or elective cases
Who cannot join
- Patients with confirmed history of difficult airway
- Patients with maxillofacial trauma or cervical spine injury or instability
- Pregnant patients
- Patients with a history of head and neck cancer
- Patients with known subglottic stenosis
- Patients requiring a double lumen tube insertion
- Patients with a history of neck radiotherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lebanon1 site, 1 recruiting
- Recruiting
American University of Beirut Medical Center
Beirut
Nancy Abou Nafeh
About this study
Official title: Enhancing Difficult Laryngoscopy Prediction: A Prospective Study on A Mixed Scoring System With Ultrasound and Traditional Metrics
This study aims to develop a comprehensive airway assessment score including traditional bedside clinical tests and ultrasound measurements with high accuracy in predicting difficult airway, and to validate it through testing it on a large population sample. The main question it aims to answer is: Is the comprehensive scoring system that includes clinical bedside and ultrasound measurements developed to predict difficult airways valid in a large population sample? Adult patients undergoing general anesthesia with American Society of Anesthesiologists (ASA) classification 1-4 will be recruited. Traditional and ultrasound measurements will be collected.
Read the detailed description
The ability to predict a difficult airway is the cornerstone of avoiding its dreaded complication. To standardize the task of airway assessment, multiple scores have been developed and subsequently validated, such as the Wilson risk sum score, El-ghanzouri risk index, Arne risk index…Despite utilizing these tools, there are situations in which subjects classified as easy airways surprisingly present with challenging airways. This has raised the need for developing and validating newer airway assessment scores, that include quantitative ultrasound measurements. This study aims to develop a comprehensive airway assessment score including traditional bedside clinical tests and ultrasound measurements with high accuracy in predicting difficult airway, and to validate it through testing it on a large population sample. After obtaining the consent from patients to participate in the study, the day before the surgery in the PAU or patients' rooms, a member of the research team with experience in ultrasound, will collect the required data either in the preoperative unit or in the patient room the day before the surgery (for admitted patients). The traditional metrics collected are: Modified Mallampati score, inter-incisor distance, upper lip bite test, the maximum range of head and neck movement, neck circumference, thyromental distance, receding mandible, buck teeth, edentulousness, presence of beard, and sternomental distance and the ultrasound measurements collected are a distance from skin to epiglottis (DSE), hyomental distance (HMD), the ratio of hyomental distance in maximal head extension to hyomental distance in neutral position (HMDR), tongue thickness (TT), the ratio of pre-epiglottic distance to the epiglottic distance at the midpoint of the VC (Pre-E/E-VC), distance from skin to the hyoid bone (DSHB), and distance from skin to vocal cords (DSVC). After induction, the level of difficulty of laryngoscopy will be collected by a member of the research team. For clinical and sonographic criteria with statistical significance, the investigators will calculate their sensitivity, specificity, and positive and negative predictive values. To determine the quantitative variable cut-off, the investigators will establish the ROC (Receiver Operating Characteristics). After checking that the area under the curve (AUC) is significantly >0.7, the investigators will choose as the cut-off, the value of the variable that corresponds to the best "sensitivity-specificity" pair. Finally, to identify independent criteria associated with difficult laryngoscopy, the investigators will perform multivariable analysis by logistic regression. These independent predictive criteria are the score parameters defined by values corresponding to their respective odd ratios. Then the investigators establish the cutoff value of the score from its ROC curve. As the patients in this study are almost all Lebanese or Arab, potential bias and influencing factors must be considered when the models are used for patients in other countries. Also, this is a single institution study, a multicenter and multiracial study is needed to develop a score that can be widely used internationally.
- Conditions
- Intubation, Laryngoscopy, Anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with difficult laryngoscopy
Intubation requiring up to three attempts, an intubation time of more than 10 min, a Cormack Lehane score more than or equal to 3, or the use of a bougie, stylet or a videolaryngoscope
Measured: 20 minutes following the scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start20 Feb 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Abou Nafeh, American University of Beirut Medical Center
- Investigators
- Nancy Abou Nafeh, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815952
- Sponsor's protocol ID
- BIO-2024-0255
- Status last verified
- Feb 2025
- First submitted
- 30 Jan 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Difficult Laryngoscopy Prediction: A Prospective Study on A Mixed Scoring System With Ultrasound and Traditional Metrics
- ClinicalTrials.gov ID
- NCT06815952
- Acronym / sponsor ID
- BIO-2024-0255
- Conditions
- Intubation, Laryngoscopy, Anesthesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 10 Feb 2025 (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.
This study aims to develop a comprehensive airway assessment score including traditional bedside clinical tests and ultrasound measurements with high accuracy in predicting difficult airway, and to validate it through testing it on a large population sample. The main question it aims to answer is: Is the comprehensive scoring system that includes clinical bedside and ultrasound measurements developed to predict difficult airways valid in a large population sample? Adult patients undergoing general anesthesia with American Society of Anesthesiologists (ASA) classification 1-4 will be recruited. Traditional and ultrasound measurements will be collected.
Detailed description
The ability to predict a difficult airway is the cornerstone of avoiding its dreaded complication. To standardize the task of airway assessment, multiple scores have been developed and subsequently validated, such as the Wilson risk sum score, El-ghanzouri risk index, Arne risk index…Despite utilizing these tools, there are situations in which subjects classified as easy airways surprisingly present with challenging airways. This has raised the need for developing and validating newer airway assessment scores, that include quantitative ultrasound measurements. This study aims to develop a comprehensive airway assessment score including traditional bedside clinical tests and ultrasound measurements with high accuracy in predicting difficult airway, and to validate it through testing it on a large population sample. After obtaining the consent from patients to participate in the study, the day before the surgery in the PAU or patients' rooms, a member of the research team with experience in ultrasound, will collect the required data either in the preoperative unit or in the patient room the day before the surgery (for admitted patients). The traditional metrics collected are: Modified Mallampati score, inter-incisor distance, upper lip bite test, the maximum range of head and neck movement, neck circumference, thyromental distance, receding mandible, buck teeth, edentulousness, presence of beard, and sternomental distance and the ultrasound measurements collected are a distance from skin to epiglottis (DSE), hyomental distance (HMD), the ratio of hyomental distance in maximal head extension to hyomental distance in neutral position (HMDR), tongue thickness (TT), the ratio of pre-epiglottic distance to the epiglottic distance at the midpoint of the VC (Pre-E/E-VC), distance from skin to the hyoid bone (DSHB), and distance from skin to vocal cords (DSVC). After induction, the level of difficulty of laryngoscopy will be collected by a member of the research team. For clinical and sonographic criteria with statistical significance, the investigators will calculate their sensitivity, specificity, and positive and negative predictive values. To determine the quantitative variable cut-off, the investigators will establish the ROC (Receiver Operating Characteristics). After checking that the area under the curve (AUC) is significantly >0.7, the investigators will choose as the cut-off, the value of the variable that corresponds to the best "sensitivity-specificity" pair. Finally, to identify independent criteria associated with difficult laryngoscopy, the investigators will perform multivariable analysis by logistic regression. These independent predictive criteria are the score parameters defined by values corresponding to their respective odd ratios. Then the investigators establish the cutoff value of the score from its ROC curve. As the patients in this study are almost all Lebanese or Arab, potential bias and influencing factors must be considered when the models are used for patients in other countries. Also, this is a single institution study, a multicenter and multiracial study is needed to develop a score that can be widely used internationally.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing general anesthesia, American Society of Anesthesiologists (ASA) classification, emergency or elective cases.
Key inclusion criteria (3 listed)
- Adult patients undergoing general anesthesia
- American Society of Anesthesiologists (ASA) classification 1-4
- Emergency or elective cases
Key exclusion criteria (7 listed)
- Patients with confirmed history of difficult airway
- Patients with maxillofacial trauma or cervical spine injury or instability
- Pregnant patients
- Patients with a history of head and neck cancer
- Patients with known subglottic stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with difficult laryngoscopy
Time frame: 20 minutes following the scan
Intubation requiring up to three attempts, an intubation time of more than 10 min, a Cormack Lehane score more than or equal to 3, or the use of a bougie, stylet or a videolaryngoscope
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Nancy Abou Nafeh, MD principal investigator
American University of Beirut Medical Center
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 Intubation and Laryngoscopy, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 21 Feb 2025. 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 Lebanon. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy Abou Nafeh, MD (01350000, na181@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with difficult laryngoscopy (time frame: 20 minutes following the scan). 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 21 Feb 2025.