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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMongi Slim Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

all patients scheduled for surgery under general anesthesia

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • upper airway sonography

    Diagnostic test

    clinical evaluation of upper airway, ultrasonographic assessement

  • upper airway sonography

    Diagnostic test

    clinical evaluation of upper airway, ultrasonographic assessement

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: difficult laryngoscopy1 intervention
Group B: Easy laryngoscopy1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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