Not Yet RecruitingNot Applicable

Difficult Airways Scores Validation Difficult Laryngoscopy and Mask Ventilation: Prospective and Evaluative Study

200 participantsStarted 2024-08-15

Plain-language summary

Clinical screening tests were included to define a difficult laryngoscopy such as history of difficult or impossible intubation, NC, MMS, retrognathia, protrusion of the upper incisors, TMD, mouth opening, dentition, macroglossia, presence of a beard, UBLT, spine mobility and palm print test for diabetes. Ultrasound airway assessment was performed: Clinical screening tests were included to define a difficult laryngoscopy such as history of difficult or impossible intubation, NC, MMS, retrognathia, protrusion of the upper incisors, TMD, mouth opening, dentition, macroglossia, presence of a beard, UBLT, spine mobility and palm print test for diabetes. Ultrasound airway assessment was performed Three parameters were measured to calculate the scores: Tongue thickness (TT) in coronal plane, Distance from the skin to hyoid bone (SHB), Distance from the skin to the thyrohyoid membrane (STM). Two scores were developed from a study conducted in 2019. The first score, to predict a difficult laryngoscopy, uses two parameters: the modified MALLAMPATI class (MMS) and the STM. A score strictly greater than 2 is predictive of a difficult laryngoscopy. The second score, to predict difficult ventilation, uses four parameters: BMI, NC, TT in coronal plane, and SHB. A score strictly greater than 20 is predictive of difficult ventilation. A well-experienced anesthesiologist performed a direct laryngoscopy and graded it as Cormack-Lehane's grading. Difficulty in intubation and/or mask ventilation was managed according to the 2017 SFAR guidelines.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Patients aged over 18 years, scheduled for visceral or orthopedic surgery, elective or otherwise requiring general anesthesia with primary intubation and laryngoscopy, receiving a muscle relaxant before exposure were eligible for this study. Exclusion Criteria: Patients with conditions preventing the evaluation of clinical intubation criteria, such as altered consciousness, agitation, dementia, craniofacial or cervical spine trauma, upper areodigestive tract tumors, upper airway abnormalities or malformations, history of cervical burns or radiation therapy, thyroid goiter, tracheal stenosis, pregnancy, up to 6 weeks post-partum and situations involving extremely urgent with an immediate life- threatening prognosis as well as those undergoing intubation techniques not relying on primary laryngoscopy (e.g. optical fiberscope for mouth opening under 2.5 cm and fixed cervical spine ) were not included in this study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

difficult laryngoscopy

Timeframe: 3 min after induction of general anesthesia

Trial details

NCT IDNCT06511427

SponsorMongi Slim Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-11-15

View on ClinicalTrials.gov More Airway Complication of Anesthesia trials