Lingual Nerve Injury in Patients With Difficult Intubation

Difficult Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04195152
• Other study ID #: IstanbulMUzeynep
• Status: Active, not recruiting
• Start date: December 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2019
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Difficult Intubation
• Lingual Nerve Injuries
• Wounds and Injuries

Intervention

Other:
• Observational
No intervention

Locations

Country	Name	City	State
Turkey	Istanbul MU Goztepe Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of emergency tracheotomy		1 year
Secondary	Incidence of cardiovascular complications		1 year
Secondary	Percentage of patients with teeth injuries		1 year
Secondary	Percentage of patients with oral mucosa injuries		1 year
Secondary	Percentage of patients with temporary difficulty in swallowing		1 year
Secondary	Percentage of patients with temporary difficulty in breathing		1 year
Secondary	Incidence of inability to taste		1 year
Secondary	Incidence of numbness in the tongue		1 year
Secondary	Percentage of patients with metallic taste in the tongue		1 year