NCT02705794

Brief 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 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 11, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 11, 2016

Completed
Last Updated

March 15, 2016

Status Verified

March 1, 2016

Enrollment Period

7 months

First QC Date

February 11, 2016

Last Update Submit

March 12, 2016

Conditions

Keywords

intubation, laryngoscopy

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 minutes

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patient admitted for various surgeries requiring general anesthesia with tracheal intubation in a tertiary care teaching institute

You may qualify if:

  • Adult patients aged 18-60 years.
  • American Society of Anesthesiologists (ASA) I or II, scheduled for elective surgeries under general anaesthesia requiring endotracheal intubation

You may not qualify if:

  • \- Patient refusal
  • ASA grade III and IV
  • Cervical spine disorder
  • Obstructive airway tumor
  • Edentulous patients /Irregular dentition
  • past history of difficult laryngoscopy and intubation.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 23968655BACKGROUND
  • Khan 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.

    PMID: 19690252BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Target Duration
8 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 11, 2016

First Posted

March 11, 2016

Study Start

June 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 15, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will share