Difficult IntubationNCT04195152
Lingual Nerve Injury in Patients With Difficult Intubation
An observational study of Difficult Intubation and Lingual Nerve Injuries, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult Intubation, Lingual Nerve Injuries
- What is being tested?
- Observational
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2019to 31 Dec 2020
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients undergo general anesthesia who have difficulty in intubation will be included in the study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul MU Goztepe Training and Research Hospital
Istanbul, 34730
About this study
Official title: 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
Read the 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.
- Conditions
- Difficult Intubation, Lingual Nerve Injuries
- Being tested
- Observational
- Keywords
- Difficult intubation, Lingual nerve injury, Body mass index
- Medical subject headings
- Lingual Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (9)
Rate of emergency tracheotomy
Measured: 1 year
Incidence of cardiovascular complications
Measured: 1 year
Percentage of patients with teeth injuries
Measured: 1 year
Percentage of patients with oral mucosa injuries
Measured: 1 year
Percentage of patients with temporary difficulty in swallowing
Measured: 1 year
Percentage of patients with temporary difficulty in breathing
Measured: 1 year
Incidence of inability to taste
Measured: 1 year
Incidence of numbness in the tongue
Measured: 1 year
Percentage of patients with metallic taste in the tongue
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start1 Dec 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Nur Orhon, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195152
- Sponsor's protocol ID
- İstanbulMUzeynep
- Status last verified
- Dec 2019
- First submitted
- 4 Dec 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Incidence of Lingual Nerve Injury and Related Factors in Patients With Difficult Intubation
- ClinicalTrials.gov ID
- NCT04195152
- Acronym / sponsor ID
- İstanbulMUzeynep
- Conditions
- Difficult Intubation, Lingual Nerve Injuries
- Keywords
- Difficult intubation, Lingual nerve injury, Body mass index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Difficult intubation group | – | Other: ObservationalAn intubation is called difficult if a normally trained anesthesiologist needs more than 3 attempts or more than 10 min for a successful endotracheal intubation. |
| Non difficult intubation group | – | Other: ObservationalAn intubation is called non difficult if a normally trained anesthesiologist needs only one attempt for a successful endotracheal intubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients undergo general anesthesia who have difficulty in intubation will be included in the study.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalNo intervention | Other | Difficult intubation group, Non difficult intubation group |
Primary outcome
The incidence of lingual nerve injury
Time frame: 1 year
The frequency of lingual nerve injury in patients with difficult intubation seen in one year period will be determined.
9 secondary outcomes
Rate of emergency tracheotomy
Time frame: 1 year
Incidence of cardiovascular complications
Time frame: 1 year
Percentage of patients with teeth injuries
Time frame: 1 year
Percentage of patients with oral mucosa injuries
Time frame: 1 year
Percentage of patients with temporary difficulty in swallowing
Time frame: 1 year
Percentage of patients with temporary difficulty in breathing
Time frame: 1 year
Incidence of inability to taste
Time frame: 1 year
Incidence of numbness in the tongue
Time frame: 1 year
Percentage of patients with metallic taste in the tongue
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Difficult Intubation and Lingual Nerve Injuries, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of lingual nerve injury (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.