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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02788253
Other study ID # A15-D11-VOL.24
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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