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

NCT02788253 | Completed

• 1 other identifier: A15-D11-VOL.24
• Study Type: observational
• Target: 3,244
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation; Difficult

Keywords

Mallampati; Intubation difficult; Mask ventilation difficult

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of patient with difficult Face Mask Ventilation

  1 day

• Number of patients with difficult tracheal intubation

  1 day

Other Outcomes (1)

• Correct Reclassification rate of patients by best view of Mallampati

  1 day

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

University Hospital of Caen

Caen, 14033, France

Location

Related Publications (1)

• Hanouz JL, Lefrancois V, Boutros M, Fiant AL, Simonet T, Buleon C. Comparison of the modified Mallampati classification score versus the best visible Mallampati score in the prediction of difficult tracheal intubation: a single-centre prospective observational study. Can J Anaesth. 2024 Oct;71(10):1353-1362. doi: 10.1007/s12630-024-02815-0. Epub 2024 Aug 15.

  PMID: 39147992 DERIVED

Study Officials

• Jean-Luc Hanouz, M.D.,Ph.D.

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: June 2, 2016
• Study Start: June 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 8, 2023

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)