Intubation; DifficultNCT02788253
Mallampati Classification vs Best Visible Mallampati for Prediction of Difficult Tracheal Intubation
An observational study of Intubation; Difficult, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Intubation; Difficult
- How many people
- 3,244 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Scheduled or unscheduled surgery
- Airway evaluation possible in both sitting and supine position
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Mallampati Classification and Best Visible Mallampati for Prediction of Difficult Tracheal Intubation
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.
Read the 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.
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.
- Conditions
- Intubation; Difficult
- Keywords
- Mallampati, Intubation difficult, Mask ventilation difficult
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (2)
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
Measured: 1 day
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)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study start1 Jun 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intubation; DifficultStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,244 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc Hanouz, M.D.,Ph.D., Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788253
- Sponsor's protocol ID
- A15-D11-VOL.24
- Status last verified
- Mar 2017
- First submitted
- 9 Feb 2016
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 39147992
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Mallampati Classification and Best Visible Mallampati for Prediction of Difficult Tracheal Intubation
- ClinicalTrials.gov ID
- NCT02788253
- Acronym / sponsor ID
- A15-D11-VOL.24
- Conditions
- Intubation; Difficult
- Keywords
- Mallampati, Intubation difficult, Mask ventilation difficult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,244 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 2 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Scheduled or unscheduled surgery
- Airway evaluation possible in both sitting and supine position
Key exclusion criteria (7 listed)
- surgery of the neck, face, and upper airway
- lung and thoracic surgery
- pregnancy
- orotracheal intubation not indicated during surgery
- nasotracheal intubation required for surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with difficult airway management
Time frame: 1 day
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
2 secondary outcomes
Number of patient with difficult Face Mask Ventilation
Time frame: 1 day
Number of patients with difficult tracheal intubation
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 39147992Hanouz 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.
- Individual participant dataSharing planned: No
Related trials for Intubation; Difficult
Enrolling by invitation
Pediatric Intubation Simulations With Bougie
Difficult Airway Intubation
Not yet recruitingObservational study
Sniper Intubation for Training of Undergraduate Medical Student
Intubation;Difficult
RecruitingObservational study
Airway Ultrasound in Oncologic Maxillofacial Patients
Head and Neck Cancer
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Luc Hanouz, M.D.,Ph.D. principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation; Difficult, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with difficult airway management (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02788253, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.