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

Intubation; Difficult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02788253
• Other study ID #: A15-D11-VOL.24
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2017
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3244
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intubation; Difficult

Locations

Country	Name	City	State
France	University Hospital of Caen	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correct Reclassification rate of patients by best view of Mallampati	Statistical analysis using reclassification methods (net reclassification improvement)	1 day
Primary	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	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
Secondary	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