Airway ManagementUS airwayNCT03991325
Sonographic Evaluation to Predict Difficult Airway Management
An observational study of Airway Management and Upper Airway Sonographic Evaluation, run by Mongi Slim Hospital at 1 site in Tunisia.
Trial summary
the aim of this study was to evaluate the accuracy of different ultrasonographic parameters and clinical tests to predict difficult airway assessment. Ultrasonographic parameters were: hyo-mental distence, tongue width, skin to epiglottis distence and skin to hyoid bone distence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Management, Upper Airway Sonographic Evaluation
- What is being tested?
- upper airway sonography
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Mar 2019to 30 May 2019
- 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: Inclusion Criteria: * patients scheduled for orthopedic or viseral surgery under general anesthesia and tracheal intubation. Exclusion Criteria: * patients with suspected tracheal stenosis * Patients with a poor quality ultrasonographic exam
Who may be able to join
- patients scheduled for orthopedic or viseral surgery under general anesthesia and tracheal intubation.
Who cannot join
- patients with suspected tracheal stenosis
- Patients with a poor quality ultrasonographic exam
Trial locations and contacts
1 site in 1 country.
About this study
the aim of this study was to evaluate the accuracy of different ultrasonographic parameters and clinical tests to predict difficult airway assessment.
Ultrasonographic parameters were: hyo-mental distence, tongue width, skin to epiglottis distence and skin to hyoid bone distence. these parameters were recorded and their predictive acurracy was studied.
Read the detailed description
the aim of this study was to evaluate the accuracy of different ultrasonographic parameters and clinical tests to predict difficult airway assessment.
Ultrasonographic parameters were: hyo-mental distence, tongue width, skin to epiglottis distence and skin to hyoid bone distence. these parameters were recorded and their predictive acurracy was studied.
This study analyzed a sample size of 200 patients undergoing elective or urgent surgery under general anesthesia and recieving neuromuscular blocking agent before laryngoscopy.
the correlation between ultrasonographic parameters and difficult laryngoscopy was studied
- 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
| Study group | Role | What they receive |
|---|---|---|
| difficult laryngoscopy | group of patients with Cormack and Lehane grade III or IV Receives: Diagnostic Test: upper airway sonography | |
| easy laryngoscopy | group of patients with Cormack and Lehane grade I or II Receives: Diagnostic Test: upper airway sonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
prediction of difficult laryngoscopy with ultrasonographic criteria
incidence of difficult laryngoscopy
Measured: 5 min after induction of general anesthesia determined by Cormack and Lehane grade
Secondary outcomes (1)
prediction of difficult mask ventilation with ultrasonographic criteria
Incidence of difficult ventilation
Measured: 3 min 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 posted19 Jun 2019
- Study start1 Mar 2019
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies 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 (actual)
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
- NCT03991325
- Sponsor's protocol ID
- sonographic evaluation airway
- Acronym
- US airway
- Status last verified
- Jun 2019
- First submitted
- 17 Jun 2019
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Evaluation to Predict Difficult Airway Management
- ClinicalTrials.gov ID
- NCT03991325
- Acronym / sponsor ID
- US airway / sonographic evaluation airway
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 19 Jun 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.
the aim of this study was to evaluate the accuracy of different ultrasonographic parameters and clinical tests to predict difficult airway assessment.
Ultrasonographic parameters were: hyo-mental distence, tongue width, skin to epiglottis distence and skin to hyoid bone distence. these parameters were recorded and their predictive acurracy was studied.
Detailed description
the aim of this study was to evaluate the accuracy of different ultrasonographic parameters and clinical tests to predict difficult airway assessment.
Ultrasonographic parameters were: hyo-mental distence, tongue width, skin to epiglottis distence and skin to hyoid bone distence. these parameters were recorded and their predictive acurracy was studied.
This study analyzed a sample size of 200 patients undergoing elective or urgent surgery under general anesthesia and recieving neuromuscular blocking agent before laryngoscopy.
the correlation between ultrasonographic parameters and difficult laryngoscopy was studied
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| difficult laryngoscopy | – | Diagnostic Test: upper airway sonographygroup of patients with Cormack and Lehane grade III or IV |
| easy laryngoscopy | – | Diagnostic Test: upper airway sonographygroup of patients with Cormack and Lehane grade I or II |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion Criteria: * patients scheduled for orthopedic or viseral surgery under general anesthesia and tracheal intubation. Exclusion Criteria: * patients with suspected tracheal stenosis * Patients with a poor quality ultrasonographic exam
Key inclusion criteria (1 listed)
- patients scheduled for orthopedic or viseral surgery under general anesthesia and tracheal intubation.
Key exclusion criteria (2 listed)
- patients with suspected tracheal stenosis
- Patients with a poor quality ultrasonographic exam
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, easy laryngoscopy |
Primary outcome
prediction of difficult laryngoscopy with ultrasonographic criteria
Time frame: 5 min after induction of general anesthesia determined by Cormack and Lehane grade
incidence of difficult laryngoscopy
1 secondary outcome
prediction of difficult mask ventilation with ultrasonographic criteria
Time frame: 3 min after induction of general anesthesia
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 19 Jun 2019.
- Individual participant dataSharing planned: Undecided
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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.
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 Management and Upper Airway Sonographic Evaluation, run by Mongi Slim Hospital at 1 site in Tunisia.
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 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: finished, as of the sponsor's last update on 19 Jun 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 Tunisia. 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?
prediction of difficult laryngoscopy with ultrasonographic criteria (time frame: 5 min after induction of general anesthesia determined by Cormack and Lehane grade). 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 Jun 2019.