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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Nancy Abou Nafeh, MD contact

01350000

na181@aub.edu.lb

Thouraya HajAli contact

01350000 ext. 5738

th64@aub.edu.lb

Lebanon1 site, 1 recruiting
  • American University of Beirut Medical Center

    Beirut

    Nancy Abou Nafeh

    Recruiting

Other trials in Lebanon

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted10 Feb 2025
  2. Study start20 Feb 2025
  3. Primary completion1 Feb 2026 (estimated)
  4. Study completion1 Feb 2026 (estimated)

Resources

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)
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

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.

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