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

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.

Study Overview

• Status: Completed
• Conditions: Intubation; Difficult

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.

• Study Type: Observational
• Enrollment (Actual): 3244

Contacts and Locations

Study Locations

• France
  • Caen, France, 14033
    • University hospital of Caen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with difficult airway management	Occurence 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	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patient with difficult Face Mask Ventilation	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	1 day
Number of patients with difficult tracheal intubation	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)	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correct Reclassification rate of patients by best view of Mallampati	Statistical analysis using reclassification methods (net reclassification improvement)	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2017
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: February 9, 2016
• First Submitted That Met QC Criteria: May 27, 2016
• First Posted (ESTIMATE): June 2, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Mallampati; Intubation difficult; Mask ventilation difficult
• Other Study ID Numbers: A15-D11-VOL.24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO