Lingual Nerve Injury in Patients With Difficult Intubation | NCT04195152

Studies
Lingual Nerve Injury in Patients With Difficult Intubation

NCT04195152

Sponsor

Istanbul Medeniyet University

Status

Unknown status

Last Update Posted

Dec 11, 2019Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Difficult Intubation
Lingual Nerve Injuries

Interventions

Observational

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2019Actual

Primary Completion Date

Jun 30, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Dec 4, 2019

First Submission Date that Met QC Criteria

Dec 10, 2019

First Posted Date

Dec 11, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2019

Last Update Posted Date

Dec 11, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zeynep Nur Orhon, Principal Investigator, Istanbul Medeniyet UniversityPrincipal Investigator

Lead Sponsor

Istanbul Medeniyet UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Observational	Other	No intervention	Difficult intubation group Non difficult intubation group

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Rate of emergency tracheotomy		1 year
Incidence of cardiovascular complications		1 year
Percentage of patients with teeth injuries

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul MU Goztepe Training and Research Hospital		Istanbul		34730	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D061222	Lingual Nerve Injuries

Ancestor Terms

ID	Term
D061221	Trigeminal Nerve Injuries
D020433	Trigeminal Nerve Diseases
D005156	Facial Neuralgia
D005155	Facial Nerve Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D057832	Watchful Waiting

Ancestor Terms

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided