Clinical trial NCT02788253: Mallampati Classification vs Best Visible Mallampati for Prediction of Difficult Tracheal Intubation
Official title: Comparison of the Mallampati Classification and Best Visible Mallampati for Prediction of Difficult Tracheal Intubation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation; Difficult
Keywords: Mallampati
Intubation difficult
Mask ventilation difficult
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2016-06-02
Enrollment: 3244
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (16 years older) scheduled for vascular, orthopedic, urologic, gynecologic, and abdominal surgery.

Airway evaluation must be possible in full Orotracheal intubation required for general anesthesia

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with difficult airway management
timeFrame: 1 day
Secondary outcomes:
measure: Number of patient with difficult Face Mask Ventilation
timeFrame: 1 day
measure: Number of patients with difficult tracheal intubation
timeFrame: 1 day
Other outcomes:
measure: Correct Reclassification rate of patients by best view of Mallampati
timeFrame: 1 day
Locations:
city: Caen
country: France
facility: University Hospital of Caen
Study officials:
affiliation: University Hospital, Caen
name: Jean-Luc Hanouz, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: