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Completed

NCT Number: NCT02788253

Mallampati Classification vs 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.

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Key information

Conditions

Intubation; Difficult

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Caen

Caen, 14033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of patients with difficult airway management

    Time frame: 1 day

    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

Secondary outcomes

  1. Number of patient with difficult Face Mask Ventilation

    Time frame: 1 day

    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

  2. Number of patients with difficult tracheal intubation

    Time frame: 1 day

    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)

Other outcomes

  1. Correct Reclassification rate of patients by best view of Mallampati

    Time frame: 1 day

    Statistical analysis using reclassification methods (net reclassification improvement)

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 2, 2016
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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