Predict Diificult Endotracheal IntubationNCT05961254
Role of Airwayultrasound in Predicting Difficult Endotracheal Intubation in Patients Undergoing General Anesthesia
An observational study of Predict Diificult Endotracheal Intubation, run by Sohag University at 1 site in Egypt.
Trial summary
Unpredictable difficult endotracheal intubation remains a challenge especially if difficult ventilation occurs. Difficult intubation is associated with many severe fatal complications including air way trauma, laryngospasm, hypoxemia, arrhythmias and potential cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Predict Diificult Endotracheal Intubation
- What is being tested?
- assesment of difficult endotracheal intubation by airway ultrasound
- Type of treatment
- Medical device
- How many people
- 170 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 31 Jan 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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adult patients from 18- 50 yrs old Patients who require endotracheal intubation for surgery under general anesthesia.
Who may be able to join
- Adult patients from 18- 50 yrs old
- Patients who require endotracheal intubation for surgery under general anesthesia.
Who cannot join
- Patients with history of previous difficult intubation.
- Neck deformity such as swelling , scar ,etc.
Trial locations and contacts
1 site in 1 country.
Abdelrahman H Abdelrahman, professor contact
About this study
Unpredictable difficult endotracheal intubation remains a challenge especially if difficult ventilation occurs. Difficult intubation is associated with many severe fatal complications including air way trauma, laryngospasm, hypoxemia, arrhythmias and potential cardiac arrest. Therefore, preoperative evaluation and prediction of potential difficult airway is very important.
Several screening tests are used in clinical practice to identify patients at the risk of difficult airway. Despite their accuracy and benefit, a small number of patients classified to an easy airway may still present an unexpected difficulty. Predicting a difficult airway is not at all an easy task for all patients .
Read more
Incidence of difficult airway and difficult intubation varies from 5% to 22% with important implications for clinical practice and patients' outcomes .
There are multiple scores used for airway assesment ,the commonest one is LEMON score. LEMON is an airway assessment score that measures factors associated with difficult intubation such as obesity, head and neck movement, jaw movement , receding mandible, long upper incisors, Mallampatti scores, maxillary incisor characteristics, decreased mouth opening ,shorten thyromental distance and short neck .
Diagnostic criteria for LEMON scoring system :
L- Look. E- Evaluation using the 3-3-2 rule. M- Mallampati. O- Obstruction. N- Neck mobility. Ultrasound (US) imaging technique is simple, portable, noninvasive tool helpful for airway assessment and management. In the last few years, there have been some reports that described various roles of US imaging in airway management. It helps in rapid assessment of the airway anatomy, not only in operation theatre but also in the intensive care unit and emergency department.
Various clinical applications of US imaging of the upper airway include identification of endotracheal tube (ETT) placement, guidance of percutaneous tracheostomy and cricothyroidotomy, detection of subglottic stenosis, prediction of difficult intubation and post-extubation stridor, prediction of paediatric ETT and double-lumen tube (DLT) size.
Recently there are researches about airway assesment by ultrasound. Several airway assesment indicies are used to help in prediction of difficult endotracheal intubation. The most commonly used indices are distance from skin to epiglottis, distance from skin to vocal cord level, and distance from skin to hyoid bone.
- Being tested
- assesment of difficult endotracheal intubation by airway ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assesment of difficult endotracheal intubation by airway ultrasoundDevice
preoperative assesment of airway by ultrasound to predict difficult endotracheal intubation in patients undergoing general anesthsia
What is being measured
The primary outcome is the main question the study is designed to answer.
ultasound airway assesment index ..distance from skin to epiglottis
to measure distance from skin to epiglottis
Measured: 6 months
ultasound airway assesment index ..distance from skin to hyoid bone
to measure distance from skin to hyoid bone
Measured: 6 months
ultasound airway assesment index ..distance from skin to vocal cord
to measure distance from skin to vocal cord
Measured: 6 months
Secondary outcomes (1)
airway ultrasound and LEMON score
compare between LEMON score and airway ultrasound in predicting difficult airway.
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 posted27 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Predict Diificult Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meril Nassry Saleeb, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961254
- Sponsor's protocol ID
- Soh-Med-23-07-19MS
- Status last verified
- Jul 2023
- First submitted
- 18 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Roth D, Pace NL, Lee A, Hovhannisyan K, Warenits AM, Arrich J, Herkner H. Bedside tests for predicting difficult airways: an abridged Cochrane diagnostic test accuracy systematic review. Anaesthesia. 2019 Jul;74(7):915-928. doi: 10.1111/anae.14608. Epub 2019 Mar 6.
PubMed 30843190Detsky ME, Jivraj N, Adhikari NK, Friedrich JO, Pinto R, Simel DL, Wijeysundera DN, Scales DC. Will This Patient Be Difficult to Intubate?: The Rational Clinical Examination Systematic Review. JAMA. 2019 Feb 5;321(5):493-503. doi: 10.1001/jama.2018.21413.
PubMed 30721300Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29.
PubMed 21447488Frerk C, Mitchell VS, McNarry AF, Mendonca C, Bhagrath R, Patel A, O'Sullivan EP, Woodall NM, Ahmad I; Difficult Airway Society intubation guidelines working group. Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults. Br J Anaesth. 2015 Dec;115(6):827-48. doi: 10.1093/bja/aev371. Epub 2015 Nov 10.
PubMed 26556848
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Airwayultrasound in Predicting Difficult Endotracheal Intubation in Patients Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT05961254
- Acronym / sponsor ID
- Soh-Med-23-07-19MS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 27 Jul 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.
Unpredictable difficult endotracheal intubation remains a challenge especially if difficult ventilation occurs. Difficult intubation is associated with many severe fatal complications including air way trauma, laryngospasm, hypoxemia, arrhythmias and potential cardiac arrest. Therefore, preoperative evaluation and prediction of potential difficult airway is very important.
Several screening tests are used in clinical practice to identify patients at the risk of difficult airway. Despite their accuracy and benefit, a small number of patients classified to an easy airway may still present an unexpected difficulty. Predicting a difficult airway is not at all an easy task for all patients .
Incidence of difficult airway and difficult intubation varies from 5% to 22% with important implications for clinical practice and patients' outcomes .
There are multiple scores used for airway assesment ,the commonest one is LEMON score. LEMON is an airway assessment score that measures factors associated with difficult intubation such as obesity, head and neck movement, jaw movement , receding mandible, long upper incisors, Mallampatti scores, maxillary incisor characteristics, decreased mouth opening ,shorten thyromental distance and short neck .
Diagnostic criteria for LEMON scoring system :
L- Look. E- Evaluation using the 3-3-2 rule. M- Mallampati. O- Obstruction. N- Neck mobility. Ultrasound (US) imaging technique is simple, portable, noninvasive tool helpful for airway assessment and management. In the last few years, there have been some reports that described various roles of US imaging in airway management. It helps in rapid assessment of the airway anatomy, not only in operation theatre but also in the intensive care unit and emergency department.
Various clinical applications of US imaging of the upper airway include identification of endotracheal tube (ETT) placement, guidance of percutaneous tracheostomy and cricothyroidotomy, detection of subglottic stenosis, prediction of difficult intubation and post-extubation stridor, prediction of paediatric ETT and double-lumen tube (DLT) size.
Recently there are researches about airway assesment by ultrasound. Several airway assesment indicies are used to help in prediction of difficult endotracheal intubation. The most commonly used indices are distance from skin to epiglottis, distance from skin to vocal cord level, and distance from skin to hyoid bone.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult patients from 18- 50 yrs old Patients who require endotracheal intubation for surgery under general anesthesia.
Key inclusion criteria (2 listed)
- Adult patients from 18- 50 yrs old
- Patients who require endotracheal intubation for surgery under general anesthesia.
Key exclusion criteria (2 listed)
- Patients with history of previous difficult intubation.
- Neck deformity such as swelling , scar ,etc.
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 |
|---|---|---|
| assesment of difficult endotracheal intubation by airway ultrasoundpreoperative assesment of airway by ultrasound to predict difficult endotracheal intubation in patients undergoing general anesthsia | Device | – |
Primary outcome
ultasound airway assesment index ..distance from skin to epiglottis
Time frame: 6 months
to measure distance from skin to epiglottis
ultasound airway assesment index ..distance from skin to hyoid bone
Time frame: 6 months
to measure distance from skin to hyoid bone
ultasound airway assesment index ..distance from skin to vocal cord
Time frame: 6 months
to measure distance from skin to vocal cord
1 secondary outcome
airway ultrasound and LEMON score
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 27 Jul 2023.
- Background: PubMed 30843190Roth D, Pace NL, Lee A, Hovhannisyan K, Warenits AM, Arrich J, Herkner H. Bedside tests for predicting difficult airways: an abridged Cochrane diagnostic test accuracy systematic review. Anaesthesia. 2019 Jul;74(7):915-928. doi: 10.1111/anae.14608. Epub 2019 Mar 6.
- Background: PubMed 30721300Detsky ME, Jivraj N, Adhikari NK, Friedrich JO, Pinto R, Simel DL, Wijeysundera DN, Scales DC. Will This Patient Be Difficult to Intubate?: The Rational Clinical Examination Systematic Review. JAMA. 2019 Feb 5;321(5):493-503. doi: 10.1001/jama.2018.21413.
- Background: PubMed 21447488Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29.
- Background: PubMed 26556848Frerk C, Mitchell VS, McNarry AF, Mendonca C, Bhagrath R, Patel A, O'Sullivan EP, Woodall NM, Ahmad I; Difficult Airway Society intubation guidelines working group. Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults. Br J Anaesth. 2015 Dec;115(6):827-48. doi: 10.1093/bja/aev371. Epub 2015 Nov 10.
- Individual participant dataSharing planned: Undecided
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.
Abdelrahman H Abdelrahman, professor contact
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 Predict Diificult Endotracheal Intubation, run by Sohag 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 2 inclusion and 2 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 27 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meril N Saleeb, resident (01287178283, mirelnasry@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ultasound airway assesment index ..distance from skin to epiglottis (time frame: 6 months). The study lists 3 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 NCT05961254, which also lists 4 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 27 Jul 2023.