Difficult Airway IntubationNCT04205331
Validity Of Ultrasound As Regards Correlation To Cormack-Lehane Grading In Obese Patients
An observational study of Difficult Airway Intubation, run by Zagazig University at 1 site in Egypt.
Trial summary
Since the introduction of real-time ultrasound (US) capabilities, ultrasound technology has been adopted and incorporated into daily practice by many medical and surgical specialties. Using US to help assess the difficult airway constitutes just yet another valuable application of this versatile technology . Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Difficult Airway Intubation
- What is being tested?
- Assessing validity of ultrasound as regards correlation to Cormack-Lehane grading in obese patients
- Type of treatment
- Medical device
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Dec 2019to 20 Oct 2020
- 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study will be conducted at Zagazig University Hospitals.The study is cross sectional observational study in which obese patients will be assessed using conventional clinical methods of airway assessment and by using US for the same patient before induction of anesthesia then correlated to the Cormack-Lehane finding after induction of anesthesia.
Who may be able to join
- Age of the patient : (21-60) years old.
- Sex : male \& female.
- Physical Status : The American Society of Anesthesiologists (ASA) II-III patients.
- Body mass index : 30 to more than 30 kg / m² .
- Operations: Laparoscopic surgeries,bariatric surgeries and any operation that requires general anesthesia with endotracheal tube placement .
Who cannot join
- Patient refusal.
- Deformity of the airway anatomy [by masses or tumors].
- Patients with thyroid swellings 'Goitre'.
- Pathology of the airway [edema,burn and arthritis].
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity Of Ultrasound As Regards Correlation To Cormack-Lehane Grading In Obese Patients: A Cross Sectional Observational Study
Since the introduction of real-time ultrasound (US) capabilities, ultrasound technology has been adopted and incorporated into daily practice by many medical and surgical specialties. Using US to help assess the difficult airway constitutes just yet another valuable application of this versatile technology . Since many anesthesia providers had already acquired proficiency in US techniques in US guided vascular access and regional nerve blocks, using US to evaluate the airway could be learned and mastered without too much difficulty. Ultrasound of the upper airway may prove to become a useful adjunct to conventional clinical assessment tools, as it has been successful in visualizing the relevant anatomy and critical structures of the airway..
Read the detailed description
The study is cross sectional observational study in which obese patients will be assessed using conventional clinical methods of airway assessment and by using US for the same patient before induction of anesthesia then correlated to the Cormack-Lehane finding after induction of anesthesia..
- Conditions
- Difficult Airway Intubation
- Being tested
- Assessing validity of ultrasound as regards correlation to Cormack-Lehane grading in obese patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessing validity of ultrasound as regards correlation to Cormack-Lehane grading in obese patientsDevice
Assessing validity of ultrasound as regards correlation to Cormack-Lehane grading in obese patients
| Study group | Role | What they receive |
|---|---|---|
| obese patients | compare between ultrasonography and conventional clinical methods of airway assessment prior to induction of anesthesia correlating it to the Cormack-Lehane scoring system after induction of anesthesia in obese patients Receives: Device: Assessing validity of ultrasound as regards correlation to Cormack-Lehane grading in obese patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of the depth of the pre-epiglottic space (Pre-E) to the distance from the epiglottis to the mid-point of the distance between the vocal cords (E-VC).
If It is [0-1] ,this suspects Cormack-Lehane Grade 1.If it is [1-2],this suspects Cormack-Lehane Grade 2.If it is [2-3],this suspects Cormack-Lehane Grade 3
Measured: through study completion, an average of 1 year
The anterior neck soft tissue thickness at the level of the vocal cords (ANS-VC)
ANS-VC >0.23 cm had a sensitivity of 85.7% in predicting a Cormack-Lehan Grade 3 or 4
Measured: through study completion, an average of 1 year
Secondary outcomes (8)
The anterior neck soft tissue thickness at the level of the hyoid bone (ANS-Hyoid)
If it is 1.69 cm [1.19 cm to 2.19 cm],this suspects difficult laryngoscopy.If it is 1.37cm [1.27 cm to 1.46 cm], this suspects easy laryngoscopy
Measured: through study completion, an average of 1 year
The hyomental distance of the patient in neutral position of the neck and in fully extended neck calculating the ratio between both of them
If The mean hyomental distance ratios is (1.02 ± 0.01) ,this suspects difficult intubation.If it is (1.14 ± 0.02) ,this suspects easy intubation
Measured: through study completion, an average of 1 year
Tongue volume will be derived from multiplication of the midsagittal cross-sectional area of the tongue by its width obtained from transverse sonograms
Large tongue volume suspects difficult laryngoscopy
Measured: through study completion, an average of 1 year
Modified Mallampati classification
Class I is visualization of the hard palate, soft palate, fauces, uvula, and pillars.
Class II is visualization of the hard palate, soft palate, fauces, and base of uvula.
Class III is visualization of the hard palate and soft palate. Class IV is visualization of only the hard palate
Measured: through study completion, an average of 1 year
Interincisor gap
If it is less than 5 cm (approximately three finger breadths) with limited forward protrusion of the mandible ,this is associated with increased risk of difficult laryngoscopy
Measured: through study completion, an average of 1 year
Thyromental distance
If < 6cm ,this predicts difficult laryngoscopy
Measured: through study completion, an average of 1 year
Sternomental distance
If < 12.5 cm ,this predicts difficult laryngoscopy
Measured: through study completion, an average of 1 year
Neck Extension and Flexion
inability to extend or flex the neck suspects difficult laryngoscopy
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start14 Dec 2019
- Primary completion20 Sep 2020 (estimated)
- Study completion20 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult Airway IntubationStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Cross-sectional
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmed Abdelrahman Mohamed El-Tawansy, Zagazig University
- Investigators
- Ahmed El-Tawansy, M.Sc., Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205331
- Sponsor's protocol ID
- 5162-23-1-2019
- Status last verified
- Dec 2019
- First submitted
- 14 Dec 2019
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol and Results will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity Of Ultrasound As Regards Correlation To Cormack-Lehane Grading In Obese Patients: A Cross Sectional Observational Study
- ClinicalTrials.gov ID
- NCT04205331
- Acronym / sponsor ID
- 5162-23-1-2019
- Conditions
- Difficult Airway Intubation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 14 Dec 2019 (actual)
- Primary completion
- 20 Sep 2020 (estimated)
- Study completion
- 20 Oct 2020 (estimated)
- First posted
- 19 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.
Since the introduction of real-time ultrasound (US) capabilities, ultrasound technology has been adopted and incorporated into daily practice by many medical and surgical specialties. Using US to help assess the difficult airway constitutes just yet another valuable application of this versatile technology . Since many anesthesia providers had already acquired proficiency in US techniques in US guided vascular access and regional nerve blocks, using US to evaluate the airway could be learned and mastered without too much difficulty. Ultrasound of the upper airway may prove to become a useful adjunct to conventional clinical assessment tools, as it has been successful in visualizing the relevant anatomy and critical structures of the airway..
Detailed description
The study is cross sectional observational study in which obese patients will be assessed using conventional clinical methods of airway assessment and by using US for the same patient before induction of anesthesia then correlated to the Cormack-Lehane finding after induction of anesthesia..
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obese patients | – | Device: Assessing validity of ultrasound as regards correlation to Cormack-Lehane grading in obese patientscompare between ultrasonography and conventional clinical methods of airway assessment prior to induction of anesthesia correlating it to the Cormack-Lehane scoring system after induction of anesthesia in obese patients |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will be conducted at Zagazig University Hospitals.The study is cross sectional observational study in which obese patients will be assessed using conventional clinical methods of airway assessment and by using US for the same patient before induction of anesthesia then correlated to the Cormack-Lehane finding after induction of anesthesia.
Key inclusion criteria (5 listed)
- Age of the patient : (21-60) years old.
- Sex : male \& female.
- Physical Status : The American Society of Anesthesiologists (ASA) II-III patients.
- Body mass index : 30 to more than 30 kg / m² .
- Operations: Laparoscopic surgeries,bariatric surgeries and any operation that requires general anesthesia with endotracheal tube placement .
Key exclusion criteria (4 listed)
- Patient refusal.
- Deformity of the airway anatomy [by masses or tumors].
- Patients with thyroid swellings 'Goitre'.
- Pathology of the airway [edema,burn and arthritis].
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 |
|---|---|---|
| Assessing validity of ultrasound as regards correlation to Cormack-Lehane grading in obese patientsAssessing validity of ultrasound as regards correlation to Cormack-Lehane grading in obese patients | Device | obese patients |
Primary outcome
The ratio of the depth of the pre-epiglottic space (Pre-E) to the distance from the epiglottis to the mid-point of the distance between the vocal cords (E-VC).
Time frame: through study completion, an average of 1 year
If It is [0-1] ,this suspects Cormack-Lehane Grade 1.If it is [1-2],this suspects Cormack-Lehane Grade 2.If it is [2-3],this suspects Cormack-Lehane Grade 3
The anterior neck soft tissue thickness at the level of the vocal cords (ANS-VC)
Time frame: through study completion, an average of 1 year
ANS-VC >0.23 cm had a sensitivity of 85.7% in predicting a Cormack-Lehan Grade 3 or 4
8 secondary outcomes
The anterior neck soft tissue thickness at the level of the hyoid bone (ANS-Hyoid)
Time frame: through study completion, an average of 1 year
The hyomental distance of the patient in neutral position of the neck and in fully extended neck calculating the ratio between both of them
Time frame: through study completion, an average of 1 year
Tongue volume will be derived from multiplication of the midsagittal cross-sectional area of the tongue by its width obtained from transverse sonograms
Time frame: through study completion, an average of 1 year
Modified Mallampati classification
Time frame: through study completion, an average of 1 year
Interincisor gap
Time frame: through study completion, an average of 1 year
Thyromental distance
Time frame: through study completion, an average of 1 year
Sternomental distance
Time frame: through study completion, an average of 1 year
Neck Extension and Flexion
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Individual participant dataSharing planned: Yes. Protocol and Results will be shared with other researchers.
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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.
Ahmed El-Tawansy, M.Sc. principal investigator
Zagazig 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 Airway Intubation, run by Zagazig 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 4 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 19 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact El-Tawansy (0201005125451, medicinemia@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ratio of the depth of the pre-epiglottic space (Pre-E) to the distance from the epiglottis to the mid-point of the distance between the vocal cords (E-VC). (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 19 Dec 2019.