UltrasoundNCT06052189
Ultrasonographic Parameters in Prediction of Difficult Laryngoscopy in Non-suspected Difficult Airway Patients
An observational study of Ultrasound and Difficult Laryngoscopy, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate the ultrasonographic parameters (distance from skin to epiglottis (DSE) and distance from skin to vocal cords (DSVC)) as preoperative predictors of difficult laryngoscopy in non-suspected difficult airway patients undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ultrasound, Difficult Laryngoscopy, Prediction
- What is being tested?
- Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 85 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 1 May 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective observational study will be carried out on 85 patients at Tanta University Hospital in the anesthesia department over a period of one year from May 2022 to May 2023, which may be extended after approval from the institutional ethical committee of the faculty of medicine at Tanta University. Laryngeal view grading according to the modified Cormack and Lehane grading scale where grades 1 and 2a are considered easy laryngoscopy and grades 2b, 3, and 4 are considered difficult laryngoscopy.
Who may be able to join
- Aged 18 - 65 years.
- Both sexes.
- Patients who aren't suspected to have a difficult airway after preoperative airway assessment by conventional clinical tests such as modified Mallampati classification (MMC), thyromental distance (TMD), inter-incisor distance (IID), cervical mobility (CM), And neck circumference (NC).
- American society of anesthesia (ASA) I, II, and III physical status.
- Scheduled for elective surgery under general anaethesia.
Who cannot join
- Patients with maxillofacial injury and airway trauma.
- Patients with a history of previous difficult intubation.
- Patients with anatomical abnormalities.
- Neck scarring, swelling, or burn.
- Pregnancy.
- Obesity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Ultrasonographic Parameters in Preoperative Prediction of Difficult Laryngoscopy in Non-suspected Difficult Airway Patients Undergoing Elective Surgery; a Prospective Observational Study
This study aims to evaluate the ultrasonographic parameters (distance from skin to epiglottis (DSE) and distance from skin to vocal cords (DSVC)) as preoperative predictors of difficult laryngoscopy in non-suspected difficult airway patients undergoing elective surgery.
Read the detailed description
Airway management is an integral part of general anesthesia. It simply aims to secure the patient's airway and achieve adequate ventilation and oxygenation for the patient undergoing surgery under general anesthesia. Unsuccessful airway management due to the unexpected difficulty in laryngoscopy is a life-threatening situation and may lead to morbidity and mortality.
Many conventional clinical tests are used in preoperative airway assessment such as modified Mallampati classification, Thyro-mental distance, inter-incisor distance, cervical mobility, and neck circumference, which are used to predict difficulty in the airway, but they have limited value and low sensitivity and specificity. Difficult laryngoscopy cannot be always predicted based on the preoperative assessment by conventional clinical tests. Some patients are thought to have an easy airway by clinical tests, but they show an unexpected difficulty in the laryngoscopy.
The laryngeal view of the patient can be assessed and graded during direct laryngoscopy using the Cormack and Lehane grading scale and its modification that describes the laryngoscopy as easy or difficult.
Ultrasonography is a valuable promising tool for preoperative airway evaluation through identifying important sonoanatomy of the upper airway such as epiglottis, thyroid cartilage, and vocal cords.
- Conditions
- Ultrasound, Difficult Laryngoscopy, Prediction
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
Ultrasonographic parameters: in the parasagittal plane (1cm from midline) with the patient lying supine, without a pillow, head, and neck in the neutral position, looking straight ahead with mouth closed and the tongue on the floor of the mouth without any movement.
| Study group | Role | What they receive |
|---|---|---|
| Easy laryngoscopy | Laryngeal view grading according to the modified Cormack and Lehane grading scale where grades 1 and 2a are considered easy laryngoscopy and grades 2b, 3, and 4 are considered difficult laryngoscopy. Receives: Procedure: Ultrasound | |
| Difficult laryngoscopy | Laryngeal view grading according to the modified Cormack and Lehane grading scale where grades 1 and 2a are considered easy laryngoscopy and grades 2b, 3, and 4 are considered difficult laryngoscopy. Receives: Procedure: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the ultrasonographic parameters and the modified Cormack and Lehane grading scale
Correlation between the ultrasonographic parameters (distance from skin to epiglottis ( DSE) and distance from skin to vocal cords (DSVC)) and the modified Cormack and Lehane grading scale of laryngoscopy as easy or difficult
Measured: 10 minutes during intubation.
Secondary outcomes (4)
Sensitivity of ultrasonographic distance from skin to epiglottis to predict difficult laryngoscopy.
Measurement of Sensitivity of ultrasonographic distance from skin to epiglottis to predict difficult laryngoscopy.
Laryngeal view grading according to the modified Cormack and Lehane grading scale where grades 1 and 2a are considered easy laryngoscopy and grades 2b, 3, and 4 are considered difficult laryngoscopy.
Measured: 10 minutes during intubation.
Sensitivity of ultrasonographic distance from skin to vocal cords to easy laryngoscopy.
Measurement of Sensitivity of ultrasonographic distance from skin to epiglottis to predict easy laryngoscopy.
Laryngeal view grading according to the modified Cormack and Lehane grading scale where grades 1 and 2a are considered easy laryngoscopy and grades 2b, 3, and 4 are considered difficult laryngoscopy.
Measured: 10 minutes during intubation.
Specificity of ultrasonographic distance from skin to epiglottis to predict difficult laryngoscopy.
Measurement of Specificity of ultrasonographic distance from skin to epiglottis to predict difficult laryngoscopy.
Laryngeal view grading according to the modified Cormack and Lehane grading scale where grades 1 and 2a are considered easy laryngoscopy and grades 2b, 3, and 4 are considered difficult laryngoscopy.
Measured: 10 minutes during intubation.
Specificity of ultrasonographic distance from skin to vocal cords to easy laryngoscopy.
Measurement of Specificity of ultrasonographic distance from skin to epiglottis to predict easy laryngoscopy.
Laryngeal view grading according to the modified Cormack and Lehane grading scale where grades 1 and 2a are considered easy laryngoscopy and grades 2b, 3, and 4 are considered difficult laryngoscopy.
Measured: 10 minutes during intubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start1 May 2022
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Other
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Salah Eldein Shalaby Abotaleb, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052189
- Sponsor's protocol ID
- 35566/6/22
- Status last verified
- Sep 2023
- First submitted
- 18 Sep 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of the study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ultrasonographic Parameters in Preoperative Prediction of Difficult Laryngoscopy in Non-suspected Difficult Airway Patients Undergoing Elective Surgery; a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06052189
- Acronym / sponsor ID
- 35566/6/22
- Conditions
- Ultrasound, Difficult Laryngoscopy, Prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 25 Sep 2023 (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 aims to evaluate the ultrasonographic parameters (distance from skin to epiglottis (DSE) and distance from skin to vocal cords (DSVC)) as preoperative predictors of difficult laryngoscopy in non-suspected difficult airway patients undergoing elective surgery.
Detailed description
Airway management is an integral part of general anesthesia. It simply aims to secure the patient's airway and achieve adequate ventilation and oxygenation for the patient undergoing surgery under general anesthesia. Unsuccessful airway management due to the unexpected difficulty in laryngoscopy is a life-threatening situation and may lead to morbidity and mortality.
Many conventional clinical tests are used in preoperative airway assessment such as modified Mallampati classification, Thyro-mental distance, inter-incisor distance, cervical mobility, and neck circumference, which are used to predict difficulty in the airway, but they have limited value and low sensitivity and specificity. Difficult laryngoscopy cannot be always predicted based on the preoperative assessment by conventional clinical tests. Some patients are thought to have an easy airway by clinical tests, but they show an unexpected difficulty in the laryngoscopy.
The laryngeal view of the patient can be assessed and graded during direct laryngoscopy using the Cormack and Lehane grading scale and its modification that describes the laryngoscopy as easy or difficult.
Ultrasonography is a valuable promising tool for preoperative airway evaluation through identifying important sonoanatomy of the upper airway such as epiglottis, thyroid cartilage, and vocal cords.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Easy laryngoscopy | – | Procedure: UltrasoundLaryngeal view grading according to the modified Cormack and Lehane grading scale where grades 1 and 2a are considered easy laryngoscopy and grades 2b, 3, and 4 are considered difficult laryngoscopy. |
| Difficult laryngoscopy | – | Procedure: UltrasoundLaryngeal view grading according to the modified Cormack and Lehane grading scale where grades 1 and 2a are considered easy laryngoscopy and grades 2b, 3, and 4 are considered difficult laryngoscopy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective observational study will be carried out on 85 patients at Tanta University Hospital in the anesthesia department over a period of one year from May 2022 to May 2023, which may be extended after approval from the institutional ethical committee of the faculty of medicine at Tanta University. Laryngeal view grading according to the modified Cormack and Lehane grading scale where grades 1 and 2a are considered easy laryngoscopy and grades 2b, 3, and 4 are considered difficult laryngoscopy.
Key inclusion criteria (5 listed)
- Aged 18 - 65 years.
- Both sexes.
- Patients who aren't suspected to have a difficult airway after preoperative airway assessment by conventional clinical tests such as modified Mallampati classification (MMC), thyromental distance (TMD), inter-incisor distance (IID), cervical mobility (CM), And neck circumference (NC).
- American society of anesthesia (ASA) I, II, and III physical status.
- Scheduled for elective surgery under general anaethesia.
Key exclusion criteria (6 listed)
- Patients with maxillofacial injury and airway trauma.
- Patients with a history of previous difficult intubation.
- Patients with anatomical abnormalities.
- Neck scarring, swelling, or burn.
- Pregnancy.
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 |
|---|---|---|
| UltrasoundUltrasonographic parameters: in the parasagittal plane (1cm from midline) with the patient lying supine, without a pillow, head, and neck in the neutral position, looking straight ahead with mouth closed and the tongue on the floor of the mouth without any movement. | Procedure or surgery | Difficult laryngoscopy, Easy laryngoscopy |
Primary outcome
Correlation between the ultrasonographic parameters and the modified Cormack and Lehane grading scale
Time frame: 10 minutes during intubation.
Correlation between the ultrasonographic parameters (distance from skin to epiglottis ( DSE) and distance from skin to vocal cords (DSVC)) and the modified Cormack and Lehane grading scale of laryngoscopy as easy or difficult
4 secondary outcomes
Sensitivity of ultrasonographic distance from skin to epiglottis to predict difficult laryngoscopy.
Time frame: 10 minutes during intubation.
Sensitivity of ultrasonographic distance from skin to vocal cords to easy laryngoscopy.
Time frame: 10 minutes during intubation.
Specificity of ultrasonographic distance from skin to epiglottis to predict difficult laryngoscopy.
Time frame: 10 minutes during intubation.
Specificity of ultrasonographic distance from skin to vocal cords to easy laryngoscopy.
Time frame: 10 minutes during intubation.
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 25 Sep 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of the study for one year.
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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 Ultrasound and Difficult Laryngoscopy, run by Tanta University at 1 site in Egypt.
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 5 inclusion and 6 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 25 Sep 2023. 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 Egypt. 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?
Correlation between the ultrasonographic parameters and the modified Cormack and Lehane grading scale (time frame: 10 minutes during intubation.). 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 25 Sep 2023.