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Mallampati Classification vs Best Visible Mallampati for Prediction of Difficult Tracheal Intubation

Comparison of the Mallampati Classification and Best Visible Mallampati for Prediction of Difficult Tracheal Intubation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02788253
Enrollment
3244
Registered
2016-06-02
Start date
2017-06-01
Completion date
2019-12-31
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation; Difficult

Keywords

Mallampati, Intubation difficult, Mask ventilation difficult

Brief summary

Mallampati score (classification of the visibility of oropharyngeal structures) should be performed in the sitting position, head in the neutral position, mouth widely open, and tongue protrudes, without phonation. However, phonation, and position modify the visibility of oropharyngeal structures and thus the Mallampati score. We aimed at evaluating the predictive value of the best observable Mallampati score as compare to the recommended Mallampati score.

Detailed description

Mallampati score (classification of the visibility of oropharyngeal structures) should be performed in the sitting position, head in the neutral position, mouth widely open, and tongue protrudes, without phonation. However, phonation, and position modify the visibility of oropharyngeal structures and thus the Mallampati score. We aimed at evaluating the predictive value of the best observable Mallampati score as compare to the recommended Mallampati score. This is a single center prospective observational study comparing the original Mallampati classification to the best visible Mallampati classification. Data and variables concerning airway management during induction of general anesthesia are recorded on a specific record sheet.

Interventions

None listed

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Scheduled or unscheduled surgery * Airway evaluation possible in both sitting and supine position

Exclusion criteria

* surgery of the neck, face, and upper airway * lung and thoracic surgery * pregnancy * orotracheal intubation not indicated during surgery * nasotracheal intubation required for surgery * selective intubation required for surgery * emergency surgery and procedure

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with difficult airway management1 dayOccurence of either difficult tracheal intubation or difficult face mask ventilation or both Difficult tracheal intubation was defined as an orotracheal intubation requiring more than 2 laryngoscopies, or lasting more than 10 min, or requiring an alternate device (gum elastic bougie, supraglottic device, videolaryngoscope) Difficult mask ventilation was defined as the inability for the anesthesiologist to provide adequate ventilation because of one or more of the following problems: inability for the unassisted anesthesiologists to maintain oxygen saturation \> 92% using 100% oxygen, excessive gas leak requiring use of the oxygen flush valve more than twice, excessive insufflation pressure (\> 25 cmH2O), absence of spirometric measures of exhaled gas flow or a tidal volume \< 3ml/kg, absence or inadequate exhaled carbon dioxide, necessity to perform two-handed mask ventilation

Secondary

MeasureTime frameDescription
Number of patient with difficult Face Mask Ventilation1 dayDifficult mask ventilation was defined as the inability for the anesthesiologist to provide adequate ventilation because of one or more of the following problems: inability for the unassisted anesthesiologists to maintain oxygen saturation \> 92% using 100% oxygen, excessive gas leak requiring use of the oxygen flush valve more than twice, excessive insufflation pressure (\> 25 cmH2O), absence of spirometric measures of exhaled gas flow or a tidal volume \< 3ml/kg, absence or inadequate exhaled carbon dioxide, necessity to perform two-handed mask ventilation
Number of patients with difficult tracheal intubation1 dayDifficult tracheal intubation was defined as an orotracheal intubation requiring more than 2 laryngoscopies, or lasting more than 10 min, or requiring an alternate device (gum elastic bougie, supraglottic device, videolaryngoscope)

Other

MeasureTime frameDescription
Correct Reclassification rate of patients by best view of Mallampati1 dayStatistical analysis using reclassification methods (net reclassification improvement)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026