Airway ManagementNCT02705794
Comparison of Modified Mallampati Classification With M-TAC in Difficult Airway
An observational study of Airway Management, run by Government Medical College, Haldwani.
Trial summary
The study title "Clinical trial of comparative evaluation of the Modified Mallampati Score and Modified Mallampati Score along with Thyromental distance, Anatomical abnormality, and Cervical mobility (M-TAC) in Predicting Difficult Airway " was undertaken to evaluate prediction of difficult airway by comparing… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Airway Management
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jan 2016
- How long will I take part?
- 8 Months
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patient admitted for various surgeries requiring general anesthesia with tracheal intubation in a tertiary care teaching institute
Who may be able to join
- -Adult patients aged 18-60 years.
- American Society of Anesthesiologists (ASA) I or II, scheduled for elective surgeries under general anaesthesia requiring endotracheal intubation
Who cannot join
- - Patient refusal
- ASA grade III and IV
- Cervical spine disorder
- Obstructive airway tumor
- Edentulous patients /Irregular dentition
- past history of difficult laryngoscopy and intubation.
Show all 10Show fewer
- trauma to the airways or to the cranial, cervical, and facial regions
- history of previous surgery, burns to airways \& adjacent structures
- Mouth opening<3 cm
- Age <18 years \& > 60 years
About this study
Official title: Clinical Trial of Comparative Evaluation of Modified Mallampati Score and Modified Mallampati Score Along With Thyromental Distance, Anatomical Abnormalities and Cervical Mobility in Predicting Difficult Airway
The study title "Clinical trial of comparative evaluation of the Modified Mallampati Score and Modified Mallampati Score along with Thyromental distance, Anatomical abnormality, and Cervical mobility (M-TAC) in Predicting Difficult Airway " was undertaken to evaluate prediction of difficult airway by comparing preoperative airway evaluation tests.
Mallampati classification is the most used screening test for detection of difficult intubation it is a classification of oropharyngeal view. Other tests include sternomental distance, thyromental distance, Wilson risk sum score, upper lip bite test, protrusion of mandible, tooth morphology, head extension, mouth opening, body mass index, 3-3-2 rule and ultrasonography of neck soft tissue. We studied 200 adult ASA I \& II patients of either sex, aged between 18-60 yrs undergoing elective surgery receiving general anesthesia.
Modified mallampati classification had four grades \& each grade was given a score, similarly thyromental distance (TMD), anatomical abnormality (AA) \& cervical mobility (CM) was classified into three grades \& each grade was given a score. For M-TAC individual scores were added.
Read the detailed description
The term 'airway' refers to the upper airway which may be defined as the extra-pulmonary air passage, consisting of the nasal and oral cavities, pharynx, larynx, trachea and large bronchi.
The most commonly applied methods of oxygenation is ventilation through a tracheal tube, a laryngeal mask, or a face mask. Problems with tracheal intubation remain the major cause of death and disability due to anaesthesia in analyses of records of the United Kingdom medical defence societies and in the American Society of Anaesthesiologists closed claims database.
'Difficult airway' is one in which there is a problem in establishing or maintaining gas exchange via a mask, an artificial airway or both. Prediction of difficult airway management remains a pivotal challenge for anaesthesiologists because accurate prediction gets altered the potentially dangerous unanticipated airway to an anticipated difficult airway with, predominantly, ample time for proper preparation. This is helpful in reducing potential complications by the allocation of experienced personnel and by using relevant equipment and well planned strategies .
However rare, in spite of this, occurrence of difficult airway management still occurs and it prompts to increase the risk of morbidity and mortality - especially when not anticipated. Unanticipated difficulty in intubation in patients for elective surgical procedures can occur in 1.5 to 13 percent cases with none of the above mentioned abnormalities resulting in both morbidity and mortality.
Several pre-operative risk factors for assessing airway difficulties have been identified, yet none have convincing diagnostic accuracy when using in isolation. Combining several risk factors increase the predictive value of the test and multivariable risk models have been developed.
As the anatomy of the head and neck region plays a leading role in deciding the fateful profile of the airway, especially associated with influential abnormality. So, simple bedside test, such as the modified Mallampati test, has been found to be of limited value and cannot be relied on for using in predicting difficult laryngoscopy. Exclusively when each individual was investigated in isolation using a single scoring test, as it has long been realized that difficult laryngoscopy is a multifactorial problem. Thus, effective prediction requires a combination of multiple tests to provide a high index of sensitivity and specificity for prediction of difficult airway. Thus, we ventured to combine Mallampati score with some other anatomical factors (thyromental distance, anatomical abnormality and cervical mobility) to develop a new and simpler clinical prediction model for a better predictive ability.
- Conditions
- Airway Management
- Keywords
- intubation, laryngoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulty of intubation
Difficulty of intubation is assessed by modified Cormack and Lehane grading. Modified Cormack and Lehane and grading consists of 4 grades. Grade 3 and 4 is considered as difficulty intubation.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startJun 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Government Medical College, Haldwani
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bikramjit Das, Government Medical College, Haldwani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705794
- Sponsor's protocol ID
- 124-IEC/01/13
- Status last verified
- Mar 2016
- First submitted
- 11 Feb 2016
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Ambesh SP, Singh N, Rao PB, Gupta D, Singh PK, Singh U. A combination of the modified Mallampati score, thyromental distance, anatomical abnormality, and cervical mobility (M-TAC) predicts difficult laryngoscopy better than Mallampati classification. Acta Anaesthesiol Taiwan. 2013 Jun;51(2):58-62. doi: 10.1016/j.aat.2013.06.005. Epub 2013 Jul 21.
PubMed 23968655Khan ZH, Mohammadi M, Rasouli MR, Farrokhnia F, Khan RH. The diagnostic value of the upper lip bite test combined with sternomental distance, thyromental distance, and interincisor distance for prediction of easy laryngoscopy and intubation: a prospective study. Anesth Analg. 2009 Sep;109(3):822-4. doi: 10.1213/ane.0b013e3181af7f0d.
PubMed 19690252
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Comparative Evaluation of Modified Mallampati Score and Modified Mallampati Score Along With Thyromental Distance, Anatomical Abnormalities and Cervical Mobility in Predicting Difficult Airway
- ClinicalTrials.gov ID
- NCT02705794
- Acronym / sponsor ID
- 124-IEC/01/13
- Conditions
- Airway Management
- Keywords
- intubation, laryngoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Government Medical College, HaldwaniUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 11 Mar 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.
The study title "Clinical trial of comparative evaluation of the Modified Mallampati Score and Modified Mallampati Score along with Thyromental distance, Anatomical abnormality, and Cervical mobility (M-TAC) in Predicting Difficult Airway " was undertaken to evaluate prediction of difficult airway by comparing preoperative airway evaluation tests.
Mallampati classification is the most used screening test for detection of difficult intubation it is a classification of oropharyngeal view. Other tests include sternomental distance, thyromental distance, Wilson risk sum score, upper lip bite test, protrusion of mandible, tooth morphology, head extension, mouth opening, body mass index, 3-3-2 rule and ultrasonography of neck soft tissue. We studied 200 adult ASA I \& II patients of either sex, aged between 18-60 yrs undergoing elective surgery receiving general anesthesia.
Modified mallampati classification had four grades \& each grade was given a score, similarly thyromental distance (TMD), anatomical abnormality (AA) \& cervical mobility (CM) was classified into three grades \& each grade was given a score. For M-TAC individual scores were added.
Detailed description
The term 'airway' refers to the upper airway which may be defined as the extra-pulmonary air passage, consisting of the nasal and oral cavities, pharynx, larynx, trachea and large bronchi.
The most commonly applied methods of oxygenation is ventilation through a tracheal tube, a laryngeal mask, or a face mask. Problems with tracheal intubation remain the major cause of death and disability due to anaesthesia in analyses of records of the United Kingdom medical defence societies and in the American Society of Anaesthesiologists closed claims database.
'Difficult airway' is one in which there is a problem in establishing or maintaining gas exchange via a mask, an artificial airway or both. Prediction of difficult airway management remains a pivotal challenge for anaesthesiologists because accurate prediction gets altered the potentially dangerous unanticipated airway to an anticipated difficult airway with, predominantly, ample time for proper preparation. This is helpful in reducing potential complications by the allocation of experienced personnel and by using relevant equipment and well planned strategies .
However rare, in spite of this, occurrence of difficult airway management still occurs and it prompts to increase the risk of morbidity and mortality - especially when not anticipated. Unanticipated difficulty in intubation in patients for elective surgical procedures can occur in 1.5 to 13 percent cases with none of the above mentioned abnormalities resulting in both morbidity and mortality.
Several pre-operative risk factors for assessing airway difficulties have been identified, yet none have convincing diagnostic accuracy when using in isolation. Combining several risk factors increase the predictive value of the test and multivariable risk models have been developed.
As the anatomy of the head and neck region plays a leading role in deciding the fateful profile of the airway, especially associated with influential abnormality. So, simple bedside test, such as the modified Mallampati test, has been found to be of limited value and cannot be relied on for using in predicting difficult laryngoscopy. Exclusively when each individual was investigated in isolation using a single scoring test, as it has long been realized that difficult laryngoscopy is a multifactorial problem. Thus, effective prediction requires a combination of multiple tests to provide a high index of sensitivity and specificity for prediction of difficult airway. Thus, we ventured to combine Mallampati score with some other anatomical factors (thyromental distance, anatomical abnormality and cervical mobility) to develop a new and simpler clinical prediction model for a better predictive ability.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 8 Months
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patient admitted for various surgeries requiring general anesthesia with tracheal intubation in a tertiary care teaching institute
Key inclusion criteria (2 listed)
- -Adult patients aged 18-60 years.
- American Society of Anesthesiologists (ASA) I or II, scheduled for elective surgeries under general anaesthesia requiring endotracheal intubation
Key exclusion criteria (10 listed)
- - Patient refusal
- ASA grade III and IV
- Cervical spine disorder
- Obstructive airway tumor
- Edentulous patients /Irregular dentition
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
Difficulty of intubation
Time frame: 10 minutes
Difficulty of intubation is assessed by modified Cormack and Lehane grading. Modified Cormack and Lehane and grading consists of 4 grades. Grade 3 and 4 is considered as difficulty intubation.
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 15 Mar 2016.
- Background: PubMed 23968655Ambesh SP, Singh N, Rao PB, Gupta D, Singh PK, Singh U. A combination of the modified Mallampati score, thyromental distance, anatomical abnormality, and cervical mobility (M-TAC) predicts difficult laryngoscopy better than Mallampati classification. Acta Anaesthesiol Taiwan. 2013 Jun;51(2):58-62. doi: 10.1016/j.aat.2013.06.005. Epub 2013 Jul 21.
- Background: PubMed 19690252Khan ZH, Mohammadi M, Rasouli MR, Farrokhnia F, Khan RH. The diagnostic value of the upper lip bite test combined with sternomental distance, thyromental distance, and interincisor distance for prediction of easy laryngoscopy and intubation: a prospective study. Anesth Analg. 2009 Sep;109(3):822-4. doi: 10.1213/ane.0b013e3181af7f0d.
- Individual participant dataSharing planned: Yes
Related trials for Airway Management
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Not yet recruitingPhase 4
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion
Airway Management, Supraglottic Airway Device Insertion
Not yet recruiting
Video Laryngeal Mask SaCoVLM Versus LMA Supreme and Ambu AuraGain in Children
Airway Management, Anesthesia, General
Not yet recruitingObservational study
Prediction of Difficult Mask Ventilation in Obese Population Undergoing Emergency Surgery
Difficult Airway Management
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Management, run by Government Medical College, Haldwani.
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 10 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 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Difficulty of intubation (time frame: 10 minutes). 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 NCT02705794, which also lists 2 linked publications.
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 15 Mar 2016.