Airway UltrasoundNCT06057818
Airway Ultrasound Versus Mallampati Score as a Predictor of Difficult Direct Laryngoscopy in Obese Patients
An observational study of Airway Ultrasound and Difficult Intubation, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of this study is to evaluate the ability of pre-operative ultrasound assessment of neck anatomy in predicting difficult laryngoscopy in obese patients undergoing elective surgery requiring tracheal intubation and comparing it to conventional methods as the Mallampati score in anticipating difficult… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Ultrasound, Difficult Intubation, Mallampati Score
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Aug 2024
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: patients of both sexes (18-60 years old) with an American Society of Anesthesiologists physical status classification score of I to III, scheduled for elective surgical procedure requiring endotracheal intubation and body mass index more than 30 kg/m2.
Who may be able to join
- Both sexes
- Age from18 to 60 years old
- With an American Society of Anesthesiologists physical status classification score of I to III,
- Scheduled for elective surgical procedure requiring endotracheal intubation
- Body mass index more than 30 kg/m2.
Who cannot join
- Patient refusal
- Emergency surgery
- Patients with history of airway or neck surgery
- Neck mobility abnormalities
- Syndromatic patients
- Pre-existing airway malformations or pathology like facial or cervical fractures, maxillofacial abnormalities, cervical tumors or goiter.
Show all 11Show fewer
- History of difficult intubation.
- Patients with tracheostomy tubes.
- Pregnant patients.
- Body mass index less than 30 kg/m2.
- ASA IV or above patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo
Fatma Ebeid, 00201095569596, dr.fatma_ebeid@yahoo.com
About this study
Official title: Airway Ultrasound Versus Mallampati Score as a Predictor of Difficult Direct Laryngoscopy in Obese Patients an Observational Study
The purpose of this study is to evaluate the ability of pre-operative ultrasound assessment of neck anatomy in predicting difficult laryngoscopy in obese patients undergoing elective surgery requiring tracheal intubation and comparing it to conventional methods as the Mallampati score in anticipating difficult laryngoscopy.
Read the detailed description
All patients enrolled in the study will be consented by written and informed consent to do the airway ultrasound before induction.
During pre-anesthetic evaluation of the patients, demographic variables will be collected from each patient and clinical screening tests to predict difficult airway will be performed in the form of Mallampati score sitting in neutral position.
The patient will be admitted to the pre-anesthesia care unit, attended by anesthesiologist experienced in ultrasound.
The ultrasound will be done with the patients seated, head held in neutral position, using the linear probe 13-6i of SonoSite model M-Turbo c with 13-6Mega Hertz frequency, Preoperative ultrasonographic airway assessment will be performed for all patients in the study, Patients will be explained about the procedure before starting the study.
Operator will position himself on the right side of the patient, holding the ultrasound transducer in the right hand, the transducer will be placed transversely just above the suprasternal notch to visualize the tracheal cartilage, a horseshoe shaped hypoechoic structure, if tracheal deviation is present, the transducer might need to be moved laterally to locate the trachea and its position should be marked out with a pen, the transducer will be moved cephalad to inspect the remaining structures.
The probe will be placed in the transverse axis, ultrasound distances will be measured as the distance from the hyoid bone to skin surface, the distance from skin to anterior commissure of the vocal cords and the distance from skin to the trachea at the level of the suprasternal notch.
All measurements will be done using the ultrasound measure and pointing in mm, gain and depth will be adjusted accordingly to obtain best view.
Difficult intubation tray and settings will be available and ready before induction.
Patients will be taken to the operating room and will be monitored by American Society of Anesthesiologists standard monitors: ECG, noninvasive blood pressure, pulse oximetry, capnography then after pre-oxygenation with fraction of inspired oxygen : 100% for 3 min, intravenous (IV) midazolam 1 mg and fentanyl 1 µg/kg, anesthesia will be induced with injection of propofol 2 mg/kg. After muscle relaxation with injection of rocuronium 0.8 mg/kg IV and ventilation with oxygen and sevoflurane 1.5% for 3 min, direct laryngoscopy will be done by attending anesthesiologist (with more than 2 years of experience post-qualification) using an appropriate size curved Macintosh blade, and the modified Cormack-Lehane (CL) laryngoscopic grade will be evaluated and documented. The correct positioning of the endotracheal tube will be confirmed via capnography and bilateral auscultation of lungs.
The view of the glottis aperture will be assessed using the modified Cormack Lehane scale at which grading of 2b, 3 and 4 will be considered a difficult intubation view for the patient.
The intubating anesthesiologist will not be involved in preoperative clinical and sonographic airway assessment. Therefore, he will be blinded to the findings of preoperative airway evaluation.
Anesthesia will be maintained by sevoflurane, booster doses of rocuronium and fentanyl as needed.
Patients are assessed regarding:
- Mallampati score
- Distance from skin to vocal cords
- Distance from skin to anterior aspect of trachea at level of suprasternal notch
- Distance from skin to hyoid bone
- Conditions
- Airway Ultrasound, Difficult Intubation, Mallampati Score
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between the Mallampati score and the airway ultrasound
Comparison between the Mallampati score and the airway ultrasound measurements in the prediction of difficult intubation in obese patients
Measured: 6 months
Secondary outcomes (1)
comparison between each airway ultrasound measurement
The sensitivity and specificity of each airway ultrasound measurement to anticipate difficult intubation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Mar 2024 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway UltrasoundStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Hany Adly Loka, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057818
- Sponsor's protocol ID
- MD99/2023
- Status last verified
- Feb 2024
- First submitted
- 20 Sep 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Ultrasound Versus Mallampati Score as a Predictor of Difficult Direct Laryngoscopy in Obese Patients an Observational Study
- ClinicalTrials.gov ID
- NCT06057818
- Acronym / sponsor ID
- MD99/2023
- Conditions
- Airway Ultrasound, Difficult Intubation, Mallampati Score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 28 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.
The purpose of this study is to evaluate the ability of pre-operative ultrasound assessment of neck anatomy in predicting difficult laryngoscopy in obese patients undergoing elective surgery requiring tracheal intubation and comparing it to conventional methods as the Mallampati score in anticipating difficult laryngoscopy.
Detailed description
All patients enrolled in the study will be consented by written and informed consent to do the airway ultrasound before induction.
During pre-anesthetic evaluation of the patients, demographic variables will be collected from each patient and clinical screening tests to predict difficult airway will be performed in the form of Mallampati score sitting in neutral position.
The patient will be admitted to the pre-anesthesia care unit, attended by anesthesiologist experienced in ultrasound.
The ultrasound will be done with the patients seated, head held in neutral position, using the linear probe 13-6i of SonoSite model M-Turbo c with 13-6Mega Hertz frequency, Preoperative ultrasonographic airway assessment will be performed for all patients in the study, Patients will be explained about the procedure before starting the study.
Operator will position himself on the right side of the patient, holding the ultrasound transducer in the right hand, the transducer will be placed transversely just above the suprasternal notch to visualize the tracheal cartilage, a horseshoe shaped hypoechoic structure, if tracheal deviation is present, the transducer might need to be moved laterally to locate the trachea and its position should be marked out with a pen, the transducer will be moved cephalad to inspect the remaining structures.
The probe will be placed in the transverse axis, ultrasound distances will be measured as the distance from the hyoid bone to skin surface, the distance from skin to anterior commissure of the vocal cords and the distance from skin to the trachea at the level of the suprasternal notch.
All measurements will be done using the ultrasound measure and pointing in mm, gain and depth will be adjusted accordingly to obtain best view.
Difficult intubation tray and settings will be available and ready before induction.
Patients will be taken to the operating room and will be monitored by American Society of Anesthesiologists standard monitors: ECG, noninvasive blood pressure, pulse oximetry, capnography then after pre-oxygenation with fraction of inspired oxygen : 100% for 3 min, intravenous (IV) midazolam 1 mg and fentanyl 1 µg/kg, anesthesia will be induced with injection of propofol 2 mg/kg. After muscle relaxation with injection of rocuronium 0.8 mg/kg IV and ventilation with oxygen and sevoflurane 1.5% for 3 min, direct laryngoscopy will be done by attending anesthesiologist (with more than 2 years of experience post-qualification) using an appropriate size curved Macintosh blade, and the modified Cormack-Lehane (CL) laryngoscopic grade will be evaluated and documented. The correct positioning of the endotracheal tube will be confirmed via capnography and bilateral auscultation of lungs.
The view of the glottis aperture will be assessed using the modified Cormack Lehane scale at which grading of 2b, 3 and 4 will be considered a difficult intubation view for the patient.
The intubating anesthesiologist will not be involved in preoperative clinical and sonographic airway assessment. Therefore, he will be blinded to the findings of preoperative airway evaluation.
Anesthesia will be maintained by sevoflurane, booster doses of rocuronium and fentanyl as needed.
Patients are assessed regarding:
- Mallampati score
- Distance from skin to vocal cords
- Distance from skin to anterior aspect of trachea at level of suprasternal notch
- Distance from skin to hyoid bone
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- patients of both sexes (18-60 years old) with an American Society of Anesthesiologists physical status classification score of I to III, scheduled for elective surgical procedure requiring endotracheal intubation and body mass index more than 30 kg/m2.
Key inclusion criteria (5 listed)
- Both sexes
- Age from18 to 60 years old
- With an American Society of Anesthesiologists physical status classification score of I to III,
- Scheduled for elective surgical procedure requiring endotracheal intubation
- Body mass index more than 30 kg/m2.
Key exclusion criteria (11 listed)
- Patient refusal
- Emergency surgery
- Patients with history of airway or neck surgery
- Neck mobility abnormalities
- Syndromatic patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison between the Mallampati score and the airway ultrasound
Time frame: 6 months
Comparison between the Mallampati score and the airway ultrasound measurements in the prediction of difficult intubation in obese patients
1 secondary outcome
comparison between each airway ultrasound measurement
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
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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.
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 Airway Ultrasound and Difficult Intubation, run by Ain Shams 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 11 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 13 Feb 2024. 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 Sherif HA Loka (00201227671174, sh_1507@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between the Mallampati score and the airway ultrasound (time frame: 6 months). 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 13 Feb 2024.