Airway Complication of AnesthesiaNCT06511427
Difficult Airways Scores Validation Difficult Laryngoscopy and Mask Ventilation: Prospective and Evaluative Study
An observational study of Airway Complication of Anesthesia and Ultrasound, run by Mongi Slim Hospital.
Trial summary
Clinical screening tests were included to define a difficult laryngoscopy such as history of difficult or impossible intubation, NC, MMS, retrognathia, protrusion of the upper incisors, TMD, mouth opening, dentition, macroglossia, presence of a beard, UBLT, spine mobility and palm print test for diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Complication of Anesthesia, Ultrasound, Laryngoscopy
- What is being tested?
- upper airway sonography
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2024to 30 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients scheduled for surgery under general anesthesia
Who may be able to join
- Patients aged over 18 years, scheduled for visceral or orthopedic surgery, elective or otherwise requiring general anesthesia with primary intubation and laryngoscopy, receiving a muscle relaxant before exposure were eligible for this study.
Who cannot join
- Patients with conditions preventing the evaluation of clinical intubation criteria, such as altered consciousness, agitation, dementia, craniofacial or cervical spine trauma, upper areodigestive tract tumors, upper airway abnormalities or malformations, history of cervical burns or radiation therapy, thyroid goiter, tracheal stenosis, pregnancy, up to 6 weeks post-partum and situations involving extremely urgent with an immediate life- threatening prognosis as well as those undergoing intubation techniques not relying on primary laryngoscopy (e.g. optical fiberscope for mouth opening under 2.5 cm and fixed cervical spine ) were not included in this study.
About this study
Official title: Validation of Clinical and Ultrasonographic Scores for Prediction of Difficult Laryngoscopy and Mask Ventilation: Prospective and Evaluative Study
Clinical screening tests were included to define a difficult laryngoscopy such as history of difficult or impossible intubation, NC, MMS, retrognathia, protrusion of the upper incisors, TMD, mouth opening, dentition, macroglossia, presence of a beard, UBLT, spine mobility and palm print test for diabetes.
Ultrasound airway assessment was performed: Clinical screening tests were included to define a difficult laryngoscopy such as history of difficult or impossible intubation, NC, MMS, retrognathia, protrusion of the upper incisors, TMD, mouth opening, dentition, macroglossia, presence of a beard, UBLT, spine mobility and palm print test for diabetes.
Read more
Ultrasound airway assessment was performed Three parameters were measured to calculate the scores: Tongue thickness (TT) in coronal plane, Distance from the skin to hyoid bone (SHB), Distance from the skin to the thyrohyoid membrane (STM). Two scores were developed from a study conducted in 2019. The first score, to predict a difficult laryngoscopy, uses two parameters: the modified MALLAMPATI class (MMS) and the STM. A score strictly greater than 2 is predictive of a difficult laryngoscopy. The second score, to predict difficult ventilation, uses four parameters: BMI, NC, TT in coronal plane, and SHB. A score strictly greater than 20 is predictive of difficult ventilation. A well-experienced anesthesiologist performed a direct laryngoscopy and graded it as Cormack-Lehane's grading.
Difficulty in intubation and/or mask ventilation was managed according to the 2017 SFAR guidelines.
Read the detailed description
The airway assessment was conducted in two phases: evaluation of clinical parameters and ultrasound parameters. Basics demographics such as age, gender, height, weight, BMI and comorbidities were noted along with the ASA classification and urgent or elective nature of the surgery. Clinical screening tests were included to define a difficult laryngoscopy such as history of difficult or impossible intubation, NC, MMS, retrognathia, protrusion of the upper incisors, TMD, mouth opening, dentition, macroglossia, presence of a beard, UBLT, spine mobility and palm print test for diabetes.
Ultrasound airway assessment was performed using a sonosite portable sonography machine with a high-frequency linear probe (10MHz) as well as a convex probe (3.5-5 MHz), with the patient lying supine and keeping the head in a neutral position. Three parameters were measured to calculate the scores: Tongue thickness (TT) in coronal plane, Distance from the skin to hyoid bone (SHB), Distance from the skin to the thyrohyoid membrane (STM). TT was measured with a low-frequency convex probe which was places submandibularly in a perpendicular plane, the cross-sectional plane was the one passing through the two lingual arteries, we considered the widest diameter. SHB was measured by placing the linear high-frequency ultrasound probe transversely over the hyoid bone. Similarly, distance from skin to the thyrohyoid membrane (STM) was measured midway between hyoid and thyroid cartilage at the level of the epiglottis.
The hyoid bone was identified as a curved echogenic structure with posterior acoustic shadow and epiglottis was identified as a curvilinear hypoechoic structure with a bright posterior air mucosal interface and hyperechoic pre-epiglottic space. Two scores were developed from a study conducted in 2019. The first score, to predict a difficult laryngoscopy, uses two parameters: the modified MALLAMPATI class (MMS) and the STM. A score strictly greater than 2 is predictive of a difficult laryngoscopy. The second score, to predict difficult ventilation, uses four parameters: BMI, NC, TT in coronal plane, and SHB. A score strictly greater than 20 is predictive of difficult ventilation. The patient was then shifted to the operating room; electrocardioscope, pulse oximetry, gas analyzer, capnography monitoring, non-invasive blood pressure, and neuromuscular blockade monitoring were connected. Other monitoring methods could be used depending on the patient condition and surgical risk, and their choice was left to the discretion of the anesthesiologist in charge of the patient. After pre-oxygenation with 100% oxygen, they were induced with intravenous injections of Sufentanil 0.3µg/kg, Propofol 3mg/kg and cisatracurium 0.15mg/kg or succinylcholine in case of a CRUSH induction. A well-experienced anesthesiologist performed a direct laryngoscopy and graded it as Cormack-Lehane's grading.
Difficulty in intubation and/or mask ventilation was managed according to the 2017 SFAR guidelines.
- Being tested
- upper airway sonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper airway sonographyDiagnostic test
clinical evaluation of upper airway, ultrasonographic assessement
upper airway sonographyDiagnostic test
clinical evaluation of upper airway, ultrasonographic assessement
| Study group | Role | What they receive |
|---|---|---|
| difficult laryngoscopy | patients with a cormack lehane classification after induction of anesthesia 3 or 4. Receives: Diagnostic Test: upper airway sonography | |
| Easy laryngoscopy | patients with a cormack lehane classification after induction of anesthesia 1 or 2. Receives: Diagnostic Test: upper airway sonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
difficult laryngoscopy
cormack-lehane grade (from 1 to 4: 1 and 2 correspond to easy laryngoscopy and 3 or 4 to difficult laryngoscopy
Measured: 3 min after induction of general anesthesia
Secondary outcomes (2)
Difficult intubation
intubation requiring more than two laryngoscopies and/or the use of an alternative technique after optimizing head position (amended Jackson), with or without external laryngeal manipulation (BURP: backwards, upwards, and rightwards pressure)
Measured: 3 minutes after induction of general anesthesia
Difficult mask ventilation
- Inability to achieve sufficient chest expansion or a tidal volume greater than dead space (3 ml/kg), an identifiable capnographic trace, or maintain SpO2 \> 92% or the Necessity to use rapid oxygen multiple times or call for another operator or the Insufflation pressure greater than 25 cmH2O;
Measured: 3 minutes after induction of general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start15 Aug 2024 (estimated)
- Primary completion15 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Complication of AnesthesiaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511427
- Sponsor's protocol ID
- difficult airway scores
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Clinical and Ultrasonographic Scores for Prediction of Difficult Laryngoscopy and Mask Ventilation: Prospective and Evaluative Study
- ClinicalTrials.gov ID
- NCT06511427
- Acronym / sponsor ID
- difficult airway scores
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 22 Jul 2024 (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.
Clinical screening tests were included to define a difficult laryngoscopy such as history of difficult or impossible intubation, NC, MMS, retrognathia, protrusion of the upper incisors, TMD, mouth opening, dentition, macroglossia, presence of a beard, UBLT, spine mobility and palm print test for diabetes.
Ultrasound airway assessment was performed: Clinical screening tests were included to define a difficult laryngoscopy such as history of difficult or impossible intubation, NC, MMS, retrognathia, protrusion of the upper incisors, TMD, mouth opening, dentition, macroglossia, presence of a beard, UBLT, spine mobility and palm print test for diabetes.
Ultrasound airway assessment was performed Three parameters were measured to calculate the scores: Tongue thickness (TT) in coronal plane, Distance from the skin to hyoid bone (SHB), Distance from the skin to the thyrohyoid membrane (STM). Two scores were developed from a study conducted in 2019. The first score, to predict a difficult laryngoscopy, uses two parameters: the modified MALLAMPATI class (MMS) and the STM. A score strictly greater than 2 is predictive of a difficult laryngoscopy. The second score, to predict difficult ventilation, uses four parameters: BMI, NC, TT in coronal plane, and SHB. A score strictly greater than 20 is predictive of difficult ventilation. A well-experienced anesthesiologist performed a direct laryngoscopy and graded it as Cormack-Lehane's grading.
Difficulty in intubation and/or mask ventilation was managed according to the 2017 SFAR guidelines.
Detailed description
The airway assessment was conducted in two phases: evaluation of clinical parameters and ultrasound parameters. Basics demographics such as age, gender, height, weight, BMI and comorbidities were noted along with the ASA classification and urgent or elective nature of the surgery. Clinical screening tests were included to define a difficult laryngoscopy such as history of difficult or impossible intubation, NC, MMS, retrognathia, protrusion of the upper incisors, TMD, mouth opening, dentition, macroglossia, presence of a beard, UBLT, spine mobility and palm print test for diabetes.
Ultrasound airway assessment was performed using a sonosite portable sonography machine with a high-frequency linear probe (10MHz) as well as a convex probe (3.5-5 MHz), with the patient lying supine and keeping the head in a neutral position. Three parameters were measured to calculate the scores: Tongue thickness (TT) in coronal plane, Distance from the skin to hyoid bone (SHB), Distance from the skin to the thyrohyoid membrane (STM). TT was measured with a low-frequency convex probe which was places submandibularly in a perpendicular plane, the cross-sectional plane was the one passing through the two lingual arteries, we considered the widest diameter. SHB was measured by placing the linear high-frequency ultrasound probe transversely over the hyoid bone. Similarly, distance from skin to the thyrohyoid membrane (STM) was measured midway between hyoid and thyroid cartilage at the level of the epiglottis.
The hyoid bone was identified as a curved echogenic structure with posterior acoustic shadow and epiglottis was identified as a curvilinear hypoechoic structure with a bright posterior air mucosal interface and hyperechoic pre-epiglottic space. Two scores were developed from a study conducted in 2019. The first score, to predict a difficult laryngoscopy, uses two parameters: the modified MALLAMPATI class (MMS) and the STM. A score strictly greater than 2 is predictive of a difficult laryngoscopy. The second score, to predict difficult ventilation, uses four parameters: BMI, NC, TT in coronal plane, and SHB. A score strictly greater than 20 is predictive of difficult ventilation. The patient was then shifted to the operating room; electrocardioscope, pulse oximetry, gas analyzer, capnography monitoring, non-invasive blood pressure, and neuromuscular blockade monitoring were connected. Other monitoring methods could be used depending on the patient condition and surgical risk, and their choice was left to the discretion of the anesthesiologist in charge of the patient. After pre-oxygenation with 100% oxygen, they were induced with intravenous injections of Sufentanil 0.3µg/kg, Propofol 3mg/kg and cisatracurium 0.15mg/kg or succinylcholine in case of a CRUSH induction. A well-experienced anesthesiologist performed a direct laryngoscopy and graded it as Cormack-Lehane's grading.
Difficulty in intubation and/or mask ventilation was managed according to the 2017 SFAR guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| difficult laryngoscopy | – | Diagnostic Test: upper airway sonographypatients with a cormack lehane classification after induction of anesthesia 3 or 4. |
| Easy laryngoscopy | – | Diagnostic Test: upper airway sonographypatients with a cormack lehane classification after induction of anesthesia 1 or 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients scheduled for surgery under general anesthesia
Key inclusion criteria (1 listed)
- Patients aged over 18 years, scheduled for visceral or orthopedic surgery, elective or otherwise requiring general anesthesia with primary intubation and laryngoscopy, receiving a muscle relaxant before exposure were eligible for this study.
Key exclusion criteria (1 listed)
- Patients with conditions preventing the evaluation of clinical intubation criteria, such as altered consciousness, agitation, dementia, craniofacial or cervical spine trauma, upper areodigestive tract tumors, upper airway abnormalities or malformations, history of cervical burns or radiation therapy, thyroid goiter, tracheal stenosis, pregnancy, up to 6 weeks post-partum and situations involving extremely urgent with an immediate life- threatening prognosis as well as those undergoing intubation techniques not relying on primary laryngoscopy (e.g. optical fiberscope for mouth opening under 2.5 cm and fixed cervical spine ) were not included in this study.
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 |
|---|---|---|
| upper airway sonographyclinical evaluation of upper airway, ultrasonographic assessement | Diagnostic test | difficult laryngoscopy |
| upper airway sonographyclinical evaluation of upper airway, ultrasonographic assessement | Diagnostic test | Easy laryngoscopy |
Primary outcome
difficult laryngoscopy
Time frame: 3 min after induction of general anesthesia
cormack-lehane grade (from 1 to 4: 1 and 2 correspond to easy laryngoscopy and 3 or 4 to difficult laryngoscopy
2 secondary outcomes
Difficult intubation
Time frame: 3 minutes after induction of general anesthesia
Difficult mask ventilation
Time frame: 3 minutes after induction of general anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Complication of Anesthesia and Ultrasound, run by Mongi Slim Hospital.
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 1 inclusion and 1 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 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
difficult laryngoscopy (time frame: 3 min after induction of general anesthesia). 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 22 Jul 2024.