Difficult IntubationNCT04226703
Indirect Laryngoscopy and Ultrasonography in Prediction of Difficult Airway
An observational study of Difficult Intubation, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
This study was designed to assess the success of indirect laryngoscopy and ultrasonographic measurements in the prediction of difficult airway. All patients were examined by indirect laryngoscopy and ultrasonography preoperatively and the predictive values for difficult airway of these methods were compared. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Difficult Intubation
- What is being tested?
- Ultrasonographic upper airway measurements
- Type of treatment
- Injection or infusion
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2019to 15 Dec 2019
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients who apply to ear, nose and throat department for any kind of otorhinolaryngological operation are included into the study.
Who may be able to join
- Subject is operated in ear, nose and throat department.
- Subject over the age of 18.
- Subject giving consent to participate in the study.
Who cannot join
- Subject under the age of 18
- Subject with a history of radiotherapy in the head and neck region,
- Subject with facial deformity,
- Subject whose neck movements have been restricted by previous trauma or surgery,
- Subject has laryngeal disease
- Previously operated subject with known airway assessment
- Morbidly obese subject with BMI> 40
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Istanbul Faculty of Medicine
Istanbul
About this study
Official title: The Role of Indirect Laryngoscopy, Clinical and Ultrasonographic Assessment in Prediction of Difficult Airway
This study was designed to assess the success of indirect laryngoscopy and ultrasonographic measurements in the prediction of difficult airway. All patients were examined by indirect laryngoscopy and ultrasonography preoperatively and the predictive values for difficult airway of these methods were compared.
Read the detailed description
Difficult airway is a condition that increases the patient's vital risk and leaves the anesthesia and surgical team in a difficult position. Failure to perform an adequate preoperative evaluation may result in the team being unprepared. Therefore, various methods have been investigated in the prediction of difficult airway from past to present. With the development of technology, imaging methods have become routine applications in clinical use. Ultrasonography and indirect laryngoscopy have been shown to be used in predicting difficult airway in the literature, but there is no study showing which is a better predictor.
- Conditions
- Difficult Intubation
- Being tested
- Ultrasonographic upper airway measurements
- Keywords
- airway, laryngoscopy, ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic upper airway measurementsDiagnostic test
Also called Indirect Laryngoscopy
Ultrasonographic upper airway measurements: Epiglottis-skin distance, Hyoid bone-skin distance, Anterior commissure-skin distance and Thickness of tounge root.
Indirect Laryngoscopy: Grading of laryngoscopic view (I=Visible anterior commissure and vocal cords, II= visible posterior part of vocal cords and posterior commissure, III= Visible posterior commissure and epiglottis, IV= Visible only epiglottis tip and posterior pharyngeal wall)
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients over the age of 18 who underwent surgery in the ear, nose and throat department. Receives: Diagnostic Test: Ultrasonographic upper airway measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cormack-Lehane Classification
The anesthesiologist, who is blind about indirect laryngoscopy findings and ultrasonographic airway measurements, performs intubation and evaluates the laryngeal view.
Measured: Three minutes after induction of anesthesia.
Epiglottis skin distance in centimeters.
The anesthesiologist, who is blind about indirect laryngoscopy findings and is experienced user of ultrasonography, measures epiglottis to skin distance.
Measured: Five minutes before induction of anesthesia.
Hyoid bone-skin distance in centimeters.
The anesthesiologist, who is blind about indirect laryngoscopy findings and is experienced user of ultrasonography, measures hyoid bone to skin distance.
Measured: Five minutes before induction of anesthesia.
Anterior commissure-skin distance in centimeters.
The anesthesiologist, who is blind about indirect laryngoscopy findings and is experienced user of ultrasonography, measures anterior commissure to skin distance.
Measured: Five minutes before induction of anesthesia.
Thickness of tongue root in centimeters.
The anesthesiologist, who is blind about indirect laryngoscopy findings and is experienced user of ultrasonography, measures thickness of tongue root.
Measured: Five minutes before induction of anesthesia.
Indirect Laryngoscopic Grade
The otolaryngologist,who is blind about ultrasonographic airway measurements of patients, performs indirect laryngoscopy and evaluates the laryngeal view.
Measured: The day before surgery
Secondary outcomes (5)
Body mass index (BMI)
Weight and height will be combined to report BMI in kg/m^2.Evaluated by the anesthesiologist who performs intubation.
Measured: The day before surgery
Thyromental distance in centimeters
The distance between thyroid notch and mentum. Evaluated by the anesthesiologist who performs intubation.
Measured: The day before surgery
Sternomental distance in centimeters.
The distance between sternal notch and mentum. Evaluated by the anesthesiologist who performs intubation.
Measured: The day before surgery
Neck circumference in centimeters.
Evaluated by the anesthesiologist who performs intubation.
Measured: The day before surgery
Mallampati classification
Evaluated by the anesthesiologist who performs intubation.
Measured: The day before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start15 Jun 2019
- Primary completion1 Nov 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Difficult IntubationStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Kara, Istanbul University
- Investigators
- Bora Başaran, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226703
- Sponsor's protocol ID
- 2019/722
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2020
- Last updated
- 13 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Parameswari A, Govind M, Vakamudi M. Correlation between preoperative ultrasonographic airway assessment and laryngoscopic view in adult patients: A prospective study. J Anaesthesiol Clin Pharmacol. 2017 Jul-Sep;33(3):353-358. doi: 10.4103/joacp.JOACP_166_17.
PubMed 29109635Sanchez-Morillo J, Estruch-Perez MJ, Hernandez-Cadiz MJ, Tamarit-Conejeros JM, Gomez-Diago L, Richart-Aznar M. Indirect laryngoscopy with rigid 70-degree laryngoscope as a predictor of difficult direct laryngoscopy. Acta Otorrinolaringol Esp. 2012 Jul-Aug;63(4):272-9. doi: 10.1016/j.otorri.2012.01.007. Epub 2012 Mar 17. English, Spanish.
PubMed 22425162
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Indirect Laryngoscopy, Clinical and Ultrasonographic Assessment in Prediction of Difficult Airway
- ClinicalTrials.gov ID
- NCT04226703
- Acronym / sponsor ID
- 2019/722
- Conditions
- Difficult Intubation
- Keywords
- airway, laryngoscopy, ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 13 Jan 2020 (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.
This study was designed to assess the success of indirect laryngoscopy and ultrasonographic measurements in the prediction of difficult airway. All patients were examined by indirect laryngoscopy and ultrasonography preoperatively and the predictive values for difficult airway of these methods were compared.
Detailed description
Difficult airway is a condition that increases the patient's vital risk and leaves the anesthesia and surgical team in a difficult position. Failure to perform an adequate preoperative evaluation may result in the team being unprepared. Therefore, various methods have been investigated in the prediction of difficult airway from past to present. With the development of technology, imaging methods have become routine applications in clinical use. Ultrasonography and indirect laryngoscopy have been shown to be used in predicting difficult airway in the literature, but there is no study showing which is a better predictor.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: Ultrasonographic upper airway measurementsPatients over the age of 18 who underwent surgery in the ear, nose and throat department. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who apply to ear, nose and throat department for any kind of otorhinolaryngological operation are included into the study.
Key inclusion criteria (3 listed)
- Subject is operated in ear, nose and throat department.
- Subject over the age of 18.
- Subject giving consent to participate in the study.
Key exclusion criteria (7 listed)
- Subject under the age of 18
- Subject with a history of radiotherapy in the head and neck region,
- Subject with facial deformity,
- Subject whose neck movements have been restricted by previous trauma or surgery,
- Subject has laryngeal disease
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 |
|---|---|---|
| Ultrasonographic upper airway measurementsAlso: Indirect LaryngoscopyUltrasonographic upper airway measurements: Epiglottis-skin distance, Hyoid bone-skin distance, Anterior commissure-skin distance and Thickness of tounge root. Indirect Laryngoscopy: Grading of laryngoscopic view (I=Visible anterior commissure and vocal cords, II= visible posterior part of vocal cords and posterior commissure, III= Visible posterior commissure and epiglottis, IV= Visible only epiglottis tip and posterior pharyngeal wall) | Diagnostic test | Study group |
Primary outcome
Cormack-Lehane Classification
Time frame: Three minutes after induction of anesthesia.
The anesthesiologist, who is blind about indirect laryngoscopy findings and ultrasonographic airway measurements, performs intubation and evaluates the laryngeal view.
Epiglottis skin distance in centimeters.
Time frame: Five minutes before induction of anesthesia.
The anesthesiologist, who is blind about indirect laryngoscopy findings and is experienced user of ultrasonography, measures epiglottis to skin distance.
Hyoid bone-skin distance in centimeters.
Time frame: Five minutes before induction of anesthesia.
The anesthesiologist, who is blind about indirect laryngoscopy findings and is experienced user of ultrasonography, measures hyoid bone to skin distance.
Anterior commissure-skin distance in centimeters.
Time frame: Five minutes before induction of anesthesia.
The anesthesiologist, who is blind about indirect laryngoscopy findings and is experienced user of ultrasonography, measures anterior commissure to skin distance.
Thickness of tongue root in centimeters.
Time frame: Five minutes before induction of anesthesia.
The anesthesiologist, who is blind about indirect laryngoscopy findings and is experienced user of ultrasonography, measures thickness of tongue root.
Indirect Laryngoscopic Grade
Time frame: The day before surgery
The otolaryngologist,who is blind about ultrasonographic airway measurements of patients, performs indirect laryngoscopy and evaluates the laryngeal view.
5 secondary outcomes
Body mass index (BMI)
Time frame: The day before surgery
Thyromental distance in centimeters
Time frame: The day before surgery
Sternomental distance in centimeters.
Time frame: The day before surgery
Neck circumference in centimeters.
Time frame: The day before surgery
Mallampati classification
Time frame: The day before surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Background: PubMed 29109635Parameswari A, Govind M, Vakamudi M. Correlation between preoperative ultrasonographic airway assessment and laryngoscopic view in adult patients: A prospective study. J Anaesthesiol Clin Pharmacol. 2017 Jul-Sep;33(3):353-358. doi: 10.4103/joacp.JOACP_166_17.
- Background: PubMed 22425162Sanchez-Morillo J, Estruch-Perez MJ, Hernandez-Cadiz MJ, Tamarit-Conejeros JM, Gomez-Diago L, Richart-Aznar M. Indirect laryngoscopy with rigid 70-degree laryngoscope as a predictor of difficult direct laryngoscopy. Acta Otorrinolaringol Esp. 2012 Jul-Aug;63(4):272-9. doi: 10.1016/j.otorri.2012.01.007. Epub 2012 Mar 17. English, Spanish.
- 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.
Bora Başaran principal investigator
Istanbul University
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, run by Istanbul 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 13 Jan 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cormack-Lehane Classification (time frame: Three minutes after induction of anesthesia.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04226703, which also lists 2 linked publications.
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 13 Jan 2020.