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Mallampati Score in Sitting or Supine Position With or Without Phonation

Sponsor
University Hospital, Caen (Other)
Overall Status
Unknown status
CT.gov ID
NCT02788253
Collaborator
(none)
2,000
Enrollment
1
Location
31
Duration (Months)
64.5
Patients Per Site Per Month

Study Details

Study Description

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. Furthermore, some patients cannot be evaluated in sitting position because (emergency, fractures, pain, supine position require for medical or surgical pathology...).

We aimed at evaluating the predictive value of the best observable Mallampati score as compare to the recommended Mallampati score.

Condition or Disease Intervention/Treatment Phase

    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. Furthermore, some patients cannot be evaluated in sitting position because (emergency, fractures, pain, supine position require for medical or surgical pathology...).

    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 Mallampati score in sitting position and supine position by 2 independent observers.

    The Mallampati score in sitting position is evaluated during anesthesia consultation.

    The Mallampati score in supine position is evaluated in the operating room before anesthesia procedure started.

    Data and variables concerning airway management during induction of general anesthesia are recorded on a specific record sheet.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Comparison of the Mallampati Score in Supine or Sitting Position With and Without Phonation to Predict Difficult Airway Management
    Study Start Date :
    Jun 1, 2015
    Anticipated Primary Completion Date :
    Dec 31, 2017
    Anticipated Study Completion Date :
    Dec 31, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with difficult tracheal intubation [1 year]

      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)

    Secondary Outcome Measures

    1. Number of patient with difficult Face Mask Ventilation [1 year]

      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

    Other Outcome Measures

    1. Correct Reclassification rate of patients by best view of Mallampati [1 year]

      Statistical analysis using reclassification methods (net reclassification improvement)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Scheduled 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital of Caen Caen France 14033

    Sponsors and Collaborators

    • University Hospital, Caen

    Investigators

    • Principal Investigator: Jean-Luc Hanouz, M.D.,Ph.D., University Hospital, Caen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Caen
    ClinicalTrials.gov Identifier:
    NCT02788253
    Other Study ID Numbers:
    • A15-D11-VOL.24
    First Posted:
    Jun 2, 2016
    Last Update Posted:
    Apr 4, 2017
    Last Verified:
    Mar 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by University Hospital, Caen
    Mallampati
    Intubation difficult
    Mask ventilation difficult

    Study Results

    No Results Posted as of Apr 4, 2017