Lingual Nerve Injury in Patients With Difficult Intubation

Investigation of the Incidence of Lingual Nerve Injury and Related Factors in Patients With Difficult Intubation

The aim of this study is to investigate the incidence of lingual nerve injury and related factors in difficult intubation cases.

Demographic data of difficult intubation cases and body mass indices, thyromental and sternomental distances, mallampati classification, neck circumference, maximum mouth opening be recorded.Numbness of the tongue and metallic taste will be questioned

Study Overview

• Status: Unknown
• Conditions: Difficult Intubation; Lingual Nerve Injuries
• Intervention / Treatment: Other: Observational

Detailed Description

The lingual nerve is the anterior descending branch of the posterior trunk of the mandibular division of the trigeminal nerve.

Lingual nerve injury is a recognised complication of orotracheal intubation and has been associated with forceful laryngoscopy.

Although left-sided neuropraxia has been reported, right-sided lesions are thought to be more common because the standard Macintosh laryngoscope exerts pressure on the right side of the tongue.

Lingual nerve injury following orotracheal intubation was first described in 1971 by Teichner who reported a right-sided neuropraxia which was attributed to direct pressure from the laryngoscope.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34730
    • Istanbul MU Goztepe Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All adult patients undergo general anesthesia who have difficulty in intubation will be included in the study.

Description

Inclusion Criteria:

All adult patients undergo general anesthesia who have difficulty in intubation will be included in the study. The same number of patients without intubation difficulties will be included in the study as a control group.

Exclusion Criteria:

1. Patients who are not intubated under general anesthesia
2. Patients undergoing regional anesthesia or peripheral nerve block
3. Patients with laryngeal mask placed will not be included in the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Difficult intubation group; An intubation is called difficult if a normally trained anesthesiologist needs more than 3 attempts or more than 10 min for a successful endotracheal intubation.	Other: Observational; No intervention
Non difficult intubation group; An intubation is called non difficult if a normally trained anesthesiologist needs only one attempt for a successful endotracheal intubation.	Other: Observational; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of lingual nerve injury	The frequency of lingual nerve injury in patients with difficult intubation seen in one year period will be determined.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of emergency tracheotomy	1 year
Incidence of cardiovascular complications	1 year
Percentage of patients with teeth injuries	1 year
Percentage of patients with oral mucosa injuries	1 year
Percentage of patients with temporary difficulty in swallowing	1 year
Percentage of patients with temporary difficulty in breathing	1 year
Incidence of inability to taste	1 year
Incidence of numbness in the tongue	1 year
Percentage of patients with metallic taste in the tongue	1 year

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Actual): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Difficult intubation; Body mass index; Lingual nerve injury
• Additional Relevant MeSH Terms: Nervous System Diseases; Stomatognathic Diseases; Mouth Diseases; Craniocerebral Trauma; Trauma, Nervous System; Cranial Nerve Diseases; Facial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Cranial Nerve Injuries; Trigeminal Nerve Injuries; Wounds and Injuries; Lingual Nerve Injuries
• Other Study ID Numbers: İstanbulMUzeynep

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No