Difficult Intubation and Tongue Protrusion

NCT ID: NCT02679027

Last Updated: 2016-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 223 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-12-31

Brief Summary

Objectives: The aim of study is to determine the possible usage of tongue movements out of the mouth in the prediction of difficult intubation.

Method: Two hundred twenty three patients undergoing abdominal surgery with general anesthesia between 2014 and 2015 were enrolled in this study. Difficult intubation was evaluated using the intubation difficulty scale (IDS) score. All intubations were performed by anesthesiologist to eliminate the differences among the anesthesiologists' experiences. IDS score were evaluated by anesthesiologists who had no idea about the measurements of the tongue movements and performed laryngeal intubation in all patients.

To define the tongue movements, horizontal lines were used. Horizontal line were passing through the mid points of mandible and upper lip height. Patients were asked to protrude tongue maximally and upward (PTMU), to protrude tongue maximally and downward (PTMD) in anatomical neutral position which was sitting down on a chair.

Conditions

Difficult Intubation, Tongue Mobility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Easy intubation

Intubation difficulty score \<5

Group Type: ACTIVE_COMPARATOR

Protrude tongue maximally and upward (PTMU)

Intervention Type: OTHER

The horizontal line was passing through the mid points of the distance between subnasale to stomion (upper lip height). Patients were asked to protrude tongue maximally and upward (PTMU).

Protrude tongue maximally and downward (PTMD)

Intervention Type: OTHER

The horizontal line was passing through the mid points of the distance between stomion to mentum (mandible height). Patients were asked to protrude tongue maximally and downward (PTMD).

Difficult intubation

Intubation difficulty score \>5

Group Type: ACTIVE_COMPARATOR

Protrude tongue maximally and upward (PTMU)

Intervention Type: OTHER

The horizontal line was passing through the mid points of the distance between subnasale to stomion (upper lip height). Patients were asked to protrude tongue maximally and upward (PTMU).

Protrude tongue maximally and downward (PTMD)

Intervention Type: OTHER

The horizontal line was passing through the mid points of the distance between stomion to mentum (mandible height). Patients were asked to protrude tongue maximally and downward (PTMD).

Interventions

Protrude tongue maximally and upward (PTMU)

The horizontal line was passing through the mid points of the distance between subnasale to stomion (upper lip height). Patients were asked to protrude tongue maximally and upward (PTMU).

Intervention Type: OTHER

Protrude tongue maximally and downward (PTMD)

The horizontal line was passing through the mid points of the distance between stomion to mentum (mandible height). Patients were asked to protrude tongue maximally and downward (PTMD).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Undergoing abdominal surgery with general anesthesia
• Able to sit

Exclusion Criteria

• Enable to sit,
• Patients had head or neck surgery,
• Patients with unstable cardiological and respiratory hemodynamic symptoms,
• Dental prosthesis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Trakya University

OTHER

Sponsor Role: lead

Responsible Party

Alkin Colak

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

tongueintubation

Identifier Type: -

Identifier Source: org_study_id