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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02922595 -
Comparison of iLTS-D® and ILMA® for Intubation With Fiberoptic Control
|
N/A | |
Completed |
NCT02051400 -
Evaluation of McGrath® MAC Video Laryngoscope
|
N/A | |
Completed |
NCT01965938 -
RIFL (Rigid and Flexing Laryngoscope) vs. Fiberoptic Bronchoscope
|
N/A | |
Completed |
NCT02769819 -
Identification of Morphological Characteristics to Predict Difficult Endotracheal Intubation Using a Flexible Fiberscope
|
N/A | |
Completed |
NCT02362568 -
Study of Interest on Cervical Ultrasound Exploration for Association With Difficult Intubation
|
N/A | |
Completed |
NCT01692522 -
Comparison of the Laryngeal Mask Ambu Aura-i Versus AirQ in Children
|
N/A | |
Recruiting |
NCT03035786 -
Airway Code Calls - Survey of Management
|
N/A | |
Completed |
NCT02290249 -
Intubation of a Pediatric Manikin in Difficult Airway by Novice Personnel: A Comparison of Glidescope and Airtraq
|
Phase 4 | |
Completed |
NCT01984970 -
McGrath Series 5 Videolaryngoscope for Double-lumen Tube Intubation
|
N/A | |
Completed |
NCT02326896 -
MACOCHA Score Predicts Intubation Failure
|
N/A | |
Completed |
NCT01474213 -
Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation
|
Phase 4 | |
Terminated |
NCT00464490 -
Use of Dexmedetomidine to Facilitate Extubation in Surgical ICU Patients Who Failed Previous Weaning Attempts
|
N/A | |
Not yet recruiting |
NCT02430415 -
Laryngoscope-assisted Lightwand Intubation and Cervical Spine Motion
|
N/A | |
Completed |
NCT01375634 -
Nasogastric Tube Insertion Using Midazolam in the Emergency Department
|
Phase 4 | |
Completed |
NCT01464489 -
Intubation Time With Low Dose Rocuronium
|
N/A | |
Terminated |
NCT01075789 -
Using Lignocaine Spray and Gel to Reduce the Pain Associated With Nasogastric Tube Insertion in Children
|
N/A | |
Recruiting |
NCT02501577 -
Comparison of Various Supraglottic Airway Devices for Fiberoptical Guided Tracheal Intubation
|
N/A | |
Completed |
NCT02566135 -
I-gel Versus Classic-Laryngeal Mask Airway (C-LMA) as a Conduit for Tracheal Intubation Using Ventilating Bougie
|
N/A | |
Recruiting |
NCT02493478 -
Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
|
||
Completed |
NCT02198742 -
A Comparison Between Two Video Laryngoscopes,in Successfully Intubating Pediatric Mannequins w/wo Difficult Airways
|
Phase 1 |