Airway AssessmentNCT04273074
Upper Airway Ultrasound in the Assessment of Difficult Visualization of the Larynx
A study testing sonographic assessment in people with Airway Assessment, run by Cairo University at 1 site in Egypt.
Trial summary
failed and Difficult tracheal intubation after direct laryngoscopy is a dreaded complication of general anesthesia as it is associated with serious morbidity and mortality. There are several conventional clinical airway assessment parameters such as the modified Mallampati classification,thyromental and hyomental… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Airway Assessment
- What is being tested?
- sonographic assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2020to 30 Jul 2021
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients above 18 years of age.
- Both genders
- Patients scheduled for elective surgery under general anesthesia
- Obese patients with BMI > 30 kg/m2
Who cannot join
- Patients with psychological disorders or those lacking co-operation.
- Patients with maxillofacial anomalies, restricted neck movements and limited mouth opening.
- American Society of Anesthesiologists (ASA) physical status class IV
- Emergency operations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Point of Care Upper Airway Ultrasound in the Assessment of Difficult Visualization of the Larynx in Obese Patients Undergoing Bariatric Surgery: a Comparison With the Conventional Cormack-Lehane Classification During Direct Laryngoscopy: an Observational Study
failed and Difficult tracheal intubation after direct laryngoscopy is a dreaded complication of general anesthesia as it is associated with serious morbidity and mortality. There are several conventional clinical airway assessment parameters such as the modified Mallampati classification,thyromental and hyomental distance, interincisor distance, neck movementsand neck circumference, which are usually used to predict a difficult airwayand are components of multivariate risk indices. Despite the use of these parameters, the diagnostic accuracy of a preanesthetic airway assessment in predicting difficult intubation is very low. Ultrasound has been evolving as a useful device for airway assessment,and sublingual ultrasound has been used for this purpose.
Read the detailed description
By an anesthesiologist who is experienced in airway ultrasound, patients will preoperative sonographic assessment . the patient will lie in the ramped up position , with head in the neutral position.The linear probe of the ultrasound machine will be used. Under the patient's chin, The probe of ultrasond will be placed , at different levels, to get the of the submandibular area in transverse view and the upper part of the neck. The transverse view will be used for measuring the the skin to hyoid, tongue volume,and the skin to epiglottis distance. The mid-sagittal view will be used for measuring the distance between epiglottis ,pre-epiglottic space , vocal cords, and the neck fat volume .
- Conditions
- Airway Assessment
- Being tested
- sonographic assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sonographic assessmentRadiation
preoperative sonographic assessment to airway
| Study group | Role | What they receive |
|---|---|---|
| preoperative sonographic assessment group | Other | preoperative sonographic assessment to airway Receives: Radiation: sonographic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epiglottis-to-vocal-cord distance
Epiglottis-to-vocal-cord distance by ultrasound
Measured: during examination up to 1 hours
Secondary outcomes (7)
Tongue width
by ultrasound
Measured: UP TO 1 HOURE
Modified Mallampati class
Class I: Soft palate, fauces, pillars, and uvula are visible.
Class II: Soft palate, fauces, and uvula are visible.
Class III: Soft palate and base of uvula are visible.
Class IV: Soft palate is not visible at all.
Class I and II were defined as "good view" and III and IV as "poor view" in the present study.
Measured: UP TO 1 HOURE
the time needed to perform the ultrasound examination.
by minute
Measured: UP TO 1 HOURE
Pre-epiglottic space
by ultrasound
Measured: UP TO 1 HOURE
Pre-epiglottic space
by ultrasound
Measured: up to 1 hour
Skin to hyoid distance
by ultrasound
Measured: up to 1 hour
Skin to epiglottis distance
by ultrasound
Measured: up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start20 Feb 2020
- Primary completion23 Jun 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway AssessmentStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Samir Wahdan, Cairo University
- Investigators
- Nadia Helmy, MD, Principal investigator, Professor of Anaesthesia, surgical ICU &Pain managementYasmine salah, Principal investigator, lecturer of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273074
- Sponsor's protocol ID
- D-18-2019
- Status last verified
- Sep 2021
- First submitted
- 13 Feb 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: still working
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Upper Airway Ultrasound in the Assessment of Difficult Visualization of the Larynx in Obese Patients Undergoing Bariatric Surgery: a Comparison With the Conventional Cormack-Lehane Classification During Direct Laryngoscopy: an Observational Study
- ClinicalTrials.gov ID
- NCT04273074
- Acronym / sponsor ID
- D-18-2019
- Conditions
- Airway Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 23 Jun 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 17 Feb 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.
failed and Difficult tracheal intubation after direct laryngoscopy is a dreaded complication of general anesthesia as it is associated with serious morbidity and mortality. There are several conventional clinical airway assessment parameters such as the modified Mallampati classification,thyromental and hyomental distance, interincisor distance, neck movementsand neck circumference, which are usually used to predict a difficult airwayand are components of multivariate risk indices. Despite the use of these parameters, the diagnostic accuracy of a preanesthetic airway assessment in predicting difficult intubation is very low. Ultrasound has been evolving as a useful device for airway assessment,and sublingual ultrasound has been used for this purpose.
Detailed description
By an anesthesiologist who is experienced in airway ultrasound, patients will preoperative sonographic assessment . the patient will lie in the ramped up position , with head in the neutral position.The linear probe of the ultrasound machine will be used. Under the patient's chin, The probe of ultrasond will be placed , at different levels, to get the of the submandibular area in transverse view and the upper part of the neck. The transverse view will be used for measuring the the skin to hyoid, tongue volume,and the skin to epiglottis distance. The mid-sagittal view will be used for measuring the distance between epiglottis ,pre-epiglottic space , vocal cords, and the neck fat volume .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| preoperative sonographic assessment group | Other | Radiation: sonographic assessmentpreoperative sonographic assessment to airway |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients above 18 years of age.
- Both genders
- Patients scheduled for elective surgery under general anesthesia
- Obese patients with BMI > 30 kg/m2
Key exclusion criteria (4 listed)
- Patients with psychological disorders or those lacking co-operation.
- Patients with maxillofacial anomalies, restricted neck movements and limited mouth opening.
- American Society of Anesthesiologists (ASA) physical status class IV
- Emergency operations
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 |
|---|---|---|
| sonographic assessmentpreoperative sonographic assessment to airway | Radiation | preoperative sonographic assessment group |
Primary outcome
Epiglottis-to-vocal-cord distance
Time frame: during examination up to 1 hours
Epiglottis-to-vocal-cord distance by ultrasound
7 secondary outcomes
Tongue width
Time frame: UP TO 1 HOURE
Modified Mallampati class
Time frame: UP TO 1 HOURE
the time needed to perform the ultrasound examination.
Time frame: UP TO 1 HOURE
Pre-epiglottic space
Time frame: UP TO 1 HOURE
Pre-epiglottic space
Time frame: up to 1 hour
Skin to hyoid distance
Time frame: up to 1 hour
Skin to epiglottis distance
Time frame: up to 1 hour
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 16 Sep 2021.
- Individual participant dataSharing planned: Undecided. still working
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Active, not recruitingPhase 3
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy
Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy
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.
Nadia Helmy, MD principal investigator
Professor of Anaesthesia, surgical ICU &Pain management
Yasmine salah principal investigator
lecturer of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sonographic assessment in people with Airway Assessment, run by Cairo 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 4 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: finished, as of the sponsor's last update on 16 Sep 2021. 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?
Epiglottis-to-vocal-cord distance (time frame: during examination up to 1 hours). 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 16 Sep 2021.