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Airway Complication of AnesthesiaNCT06511427

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

An observational study of Airway Complication of Anesthesia and Ultrasound, run by Mongi Slim Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
upper airway sonography
How many people
200 participants
Where
No sites listed yet
Study dates
15 Aug 2024to 30 Dec 2024
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: all patients scheduled for surgery under general anesthesia

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: Validation of Clinical and Ultrasonographic Scores for Prediction of Difficult Laryngoscopy and Mask Ventilation: Prospective and Evaluative Study

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.

Read more

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.

Being tested
upper airway sonography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • upper airway sonographyDiagnostic test

    clinical evaluation of upper airway, ultrasonographic assessement

  • upper airway sonographyDiagnostic test

    clinical evaluation of upper airway, ultrasonographic assessement

Study groups in NCT06511427
Study groupRoleWhat they receive
difficult laryngoscopypatients with a cormack lehane classification after induction of anesthesia 3 or 4.
Receives: Diagnostic Test: upper airway sonography
Easy laryngoscopypatients with a cormack lehane classification after induction of anesthesia 1 or 2.
Receives: Diagnostic Test: upper airway sonography

What is being measured

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

  1. difficult laryngoscopy

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

    Measured: 3 min after induction of general anesthesia

Secondary outcomes (2)
  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)

    Measured: 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;

    Measured: 3 minutes after induction of general anesthesia

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2024
  2. Study start15 Aug 2024 (estimated)
  3. Primary completion15 Nov 2024 (estimated)
  4. Study completion30 Dec 2024 (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
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06511427
Sponsor's protocol ID
difficult airway scores
Status last verified
Jul 2024
First submitted
16 Jul 2024
Last updated
22 Jul 2024
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 Airway Complication of Anesthesia and Ultrasound, run by Mongi Slim Hospital.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

difficult laryngoscopy (time frame: 3 min after induction of general anesthesia). 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 22 Jul 2024.

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