Lingual Nerve Injury in Patients With Difficult Intubation

NCT04195152 | Unknown

• 1 other identifier: İstanbulMUzeynep
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Difficult Intubation; Lingual Nerve Injuries

Keywords

Difficult intubation; Lingual nerve injury; Body mass index

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (2)

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

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

Interventions

Observational OTHER

No intervention

Difficult intubation group; Non difficult intubation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul MU Goztepe Training and Research Hospital

Istanbul, 34730, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lingual Nerve Injuries

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Trigeminal Nerve Injuries; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 11, 2019
• Study Start: December 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: December 11, 2019

Record last verified: 2019-12

Locations

TU (1)