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Not yet recruitingNCT06511427Updated Jul 22, 2024

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

An observational study in Airway Complication of Anesthesia, Ultrasound and Laryngoscopy, sponsored by Mongi Slim Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-22.

Sponsored by Mongi Slim Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 11 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

The airway assessment was conducted in two phases: evaluation of clinical parameters and ultrasound parameters. Basics demographics such as age, gender, height, weight, BMI and comorbidities were noted along with the ASA classification and urgent or elective nature of the surgery. 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 using a sonosite portable sonography machine with a high-frequency linear probe (10MHz) as well as a convex probe (3.5-5 MHz), with the patient lying supine and keeping the head in a neutral position. 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). TT was measured with a low-frequency convex probe which was places submandibularly in a perpendicular plane, the cross-sectional plane was the one passing through the two lingual arteries, we considered the widest diameter. SHB was measured by placing the linear high-frequency ultrasound probe transversely over the hyoid bone. Similarly, distance from skin to the thyrohyoid membrane (STM) was measured midway between hyoid and thyroid cartilage at the level of the epiglottis.

The hyoid bone was identified as a curved echogenic structure with posterior acoustic shadow and epiglottis was identified as a curvilinear hypoechoic structure with a bright posterior air mucosal interface and hyperechoic pre-epiglottic space. 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. The patient was then shifted to the operating room; electrocardioscope, pulse oximetry, gas analyzer, capnography monitoring, non-invasive blood pressure, and neuromuscular blockade monitoring were connected. Other monitoring methods could be used depending on the patient condition and surgical risk, and their choice was left to the discretion of the anesthesiologist in charge of the patient. After pre-oxygenation with 100% oxygen, they were induced with intravenous injections of Sufentanil 0.3µg/kg, Propofol 3mg/kg and cisatracurium 0.15mg/kg or succinylcholine in case of a CRUSH induction. 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.

02

Conditions studied

  • Airway Complication of Anesthesia
  • Ultrasound
  • Laryngoscopy
  • Difficult Airways
03

In context

Lead sponsor

Mongi Slim Hospital is the lead sponsor of 38 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

all patients scheduled for surgery under general anesthesia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • difficult laryngoscopy

    patients with a cormack lehane classification after induction of anesthesia 3 or 4.

    Diagnostic Test: upper airway sonography

  • Easy laryngoscopy

    patients with a cormack lehane classification after induction of anesthesia 1 or 2.

    Diagnostic Test: upper airway sonography

Interventions

  • Diagnostic testupper airway sonography

    clinical evaluation of upper airway, ultrasonographic assessement

  • Diagnostic testupper airway sonography

    clinical evaluation of upper airway, ultrasonographic assessement

06

What researchers measure

Primary outcomes

  1. difficult laryngoscopy

    cormack-lehane grade (from 1 to 4: 1 and 2 correspond to easy laryngoscopy and 3 or 4 to difficult laryngoscopy

    Time frame: 3 min after induction of general anesthesia

Secondary outcomes

  1. Difficult intubation

    intubation requiring more than two laryngoscopies and/or the use of an alternative technique after optimizing head position (amended Jackson), with or without external laryngeal manipulation (BURP: backwards, upwards, and rightwards pressure)

    Time frame: 3 minutes after induction of general anesthesia

  2. Difficult mask ventilation

    1. Inability to achieve sufficient chest expansion or a tidal volume greater than dead space (3 ml/kg), an identifiable capnographic trace, or maintain SpO2 \> 92% or the Necessity to use rapid oxygen multiple times or call for another operator or the Insufflation pressure greater than 25 cmH2O;

    Time frame: 3 minutes after induction of general anesthesia

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2024; primary completion for Nov 2024, 3 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 16, 2024
First posted
Jul 22, 2024
StartEst.
Aug 15, 2024
Primary completionEst.
Nov 15, 2024
CompletionEst.
Dec 30, 2024
Last update
Jul 22, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06511427
Lead sponsor
Mongi Slim Hospital
Responsible party
Mhamed Sami Mebazaa (Professor, Mongi Slim Hospital) — Principal investigator
First posted
Jul 22, 2024
Start date
Aug 15, 2024 (estimated)
Primary completion
Nov 15, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Jul 22, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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