Intubation; Difficult Clinical Trial
Official title:
Comparison of the Mallampati Classification and Best Visible Mallampati for Prediction of Difficult Tracheal Intubation
Verified date | March 2017 |
Source | University Hospital, Caen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | University Hospital of Caen | Caen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Caen |
France,
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 |
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