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Sponsor study identifier
observational
100
1 country
1
Study Start
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 13, 2015
Actual (reported)December 28, 2015
Actual (reported)October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Macintosh Blade Length Measurement (in centimeters)
Length of Macintosh blade size 3 and 4 as such (static) and during active direct laryngoscopy (active).
0 to 5-minutes
Macintosh Blade Width Measurement (in centimeters)
Width of Macintosh blade size 3 and 4 as such (static) and during active direct laryngoscopy (active).
0 to 5-minutes
Inter-incisor Angle on Macintosh Blade Contact Point (in degrees)
The angle formed by the line between the two contact points, viz. a point formed by upper incisor contact of upper flange curve (convex) of the Macintosh laryngoscope blade, and a point of contact between the lower incisor contact with lower flange curve (concave curve) of the Macintosh laryngoscope blade. The line formed by joining these two contact points with the baseline of the laryngoscope will form an angle. This angle will be noted as functional separation of eugnathic, retrognathic or prognathic maxilo-mandibular orientation
0 to 5-minutes
Upper Airway Measurements (in centimeters)
0 to 5-minutes
Correlation Assessment
0 to 5-minutes
Tracheal intubation with direct laryngoscopy using Macintosh laryngoscope blade
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients scheduled for surgery under general anaesthesia with airway control by direct laryngoscopy and tracheal intubation
Sir Ganga Ram Hospital
New Delhi, 110060, India
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
First Submitted
December 13, 2015
First Posted
December 28, 2015
Study Start
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 2030
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 26, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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