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Evaluation of Functional Dimensions of Macintosh Laryngoscope Blade During Direct Laryngoscopy in Patients With Normal Mouth Opening

NCT02639897 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-04-27

No results posted yet for this study

Summary

Direct laryngoscopy and intubation is an essential initial aspect of airway access during general anesthesia. To perform the procedure effectively, it requires adequate mouth opening, head and neck movement, and a normal temporo-mandibular joint mobility. Any issue with the above three results in a compromised upper airway at the outset and the condition is known as anticipated difficult airway, i.e. an airway that is difficult to access with conventional laryngoscopy and intubation methods. To overcome the difficulty, either one has to resort to newer advanced technique and equipment or the available conventional technique needs to be refined and modified to suit the requirement. While the former requires extraordinary expertise and finances, an option difficult to achieve in developing countries; the latter warrants focused interest to develop alternative approach with the same set of equipments.

Since submucous fibrosis and the associated restricted mouth opening have taken the proposition of an epidemic owing to widespread use of betel nut and tobacco; these patients, when requiring surgery, are difficult candidates for GA and airway control. The fact that, when they arrive as pre-surgical candidates, they have variable degree of mouth opening restriction, which if approached with a strategy, may be amenable to conventional control of airway. If investigators paint all the patients with mouth restriction as difficult airway, it will result in uncalled surgical, economic, health system and psychological burden. Therefore, it is prudent to undertake research relating to refinement of airway access techniques with the easily available, cheap and user- friendly equipment (conventional laryngoscope), such that a proportion of above stated burden can be reduced.

In view of the above, investigators plan to undertake a study to enhance our working knowledge with a conventional laryngoscope (Macintosh) to facilitate ways to control the airway difficulty secondary to mouth opening restriction. Investigators believe that the prospective knowledge thus generated would help us identify whether there is a feasibility of conventional airway management or an alternative advanced access technique is needed in the first place. This will prevent undue cancellations, delayed surgeries, and patient morbidity.

Conditions

  • Submucous Fibrosis

Interventions

OTHER

Direct Laryngoscopy

Tracheal intubation with direct laryngoscopy using Macintosh laryngoscope blade

Sponsors & Collaborators

  • Sir Ganga Ram Hospital

    lead OTHER

Principal Investigators

  • Amitabh Dutta, MD · Sir Ganga Ram Hospital, New Delhi, INDIA

  • Ameya Pappu, MBBS · Sir Ganga Ram Hospital, New Delhi, INDIA

  • Nitin Sethi, DNB · Sir Ganga Ram Hospital, New Delhi, INDIA

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2030-06-30
Completion
2030-07-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02639897 on ClinicalTrials.gov