Difficult IntubationNCT04168840
Ultrasound Parameters to Predict Difficult Airway
An observational study of Difficult Intubation, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
Ultrasound has become an essential tool for the daily work of any doctor, but in certain specialties such as Anaesthesiology, its use has greatly increased the safety offered to patients throughout the perioperative period, either to perform nerve blocks, for vascular access, intraoperative hemodynamic management or… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Difficult Intubation
- What is being tested?
- Compare clinical test with ultrasound parameters
- How many people
- 209 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2019to 13 Jan 2020
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing scheduled surgery requiring orotracheal intubation.
Who may be able to join
- Patients (male or female) ASA I-III, aged between 18 and 90 years, undergoing scheduled surgery requiring orotracheal intubation. The signature of the informed consent is required authorizing its inclusion in the study.
Who cannot join
- Obesity class II defined as a BMI greater than 35.
- Pregnant.
- Cervical tumors, goiter or patients who have required radiotherapy at the cervical level
- Abnormalities that condition anatomy alterations such as facial / cervical fractures.
- Maxillofacial abnormalities
- People who cannot give their consent.
Trial locations and contacts
1 site in 1 country.
About this study
Ultrasound has become an essential tool for the daily work of any doctor, but in certain specialties such as Anaesthesiology, its use has greatly increased the safety offered to patients throughout the perioperative period, either to perform nerve blocks, for vascular access, intraoperative hemodynamic management or any other use that allows increasing quality of care.
The management of the upper airway and the diagnosis of pathological conditions are essential skills for any doctor especially for Anaesthesiologist, ER physician, or Intensive Care physician. Because an inadequate airway management continues to be an important contributor to patient mortality and morbidity, any tool that can improve it should be considered as an addition to conventional clinical evaluation.
Read more
Unfortunately, most of the clinical parameters that should allow us to assess a potential difficult airway, do not always lead us to an adequate prediction, that is why US(Ultrasound) is use as an emerging tool in many fields, is also gathering strength in this search for a definitive predictor parameter.
Ultrasound has many obvious advantages (safe,fast, repeatable, portable, widely available and gives dynamic images in real time).
Sonographic studies are operator-dependent and although the identification of basic structures could be acquired with only a few hours of training, but more complex studies require a learning curve of months or even years. The high frequency linear probe (5-14 MHz) is probably the most suitable for the airway because images are of superficial structures (within 0-5 cm below the skin surface).
The growing academic interest in the use of US to look for predictors of difficult airway is centred mainly on measurements at the level of pretracheal tissues.
But the greatest limitation of these studies is the disparity of the fat distribution that exists between different ethnic groups and and sexes, and the lack of standardization method in patient´s intubation conditions.
So, the investigator propose to assess different ultrasound windows at the level of pretracheal tissues such as independent predictors of Difficult Airway.
- Conditions
- Difficult Intubation
- Being tested
- Compare clinical test with ultrasound parameters
- Keywords
- ultrasound, difficult airway, difficult intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compare clinical test with ultrasound parametersDiagnostic test
Compare various clinical test with four ultrasound parameters to predict difficult intubation.
| Study group | Role | What they receive |
|---|---|---|
| Patient undergoing general anesthesia with intubation | Patient undergoing general anesthesia with intubation We will explore clinical airway parameters and external ultrasound parameters of the airway Receives: Diagnostic Test: Compare clinical test with ultrasound parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior neck soft tissue thickness measured by ultrasound at hyoid bone
Distance from skin to the midline of hyoid bone measure with lineal ultrasound probe
Measured: 5 minutes
Anterior neck soft tissue thickness measured by ultrasound at thyrohyoid membrane
Distance from skin to midline of epiglottis measure with lineal ultrasound probe
Measured: 5 minutes
Anterior neck soft tissue thickness measured by ultrasound at anterior commissure of vocal cords
Distance from skin to anterior commisure of vocal cords measure with lineal ultrasound probe
Measured: 5 minutes
Anterior neck soft tissue thickness measured by ultrasound at thyrohyoid membrane. Preepiglottic Area.
Calculated with distance from skin to midline of epiglottis and 1 centimeterto left and right side.
Measured: 5 minutes
Secondary outcomes (6)
Modified Mallampati Score
Class I: Soft palate, uvula, fauces, pillars visible. Class II: Soft palate, major part of uvula, fauces visible. Class III: Soft palate, base of uvula visible. Class IV: Only hard palate visible. Class I is better than Class IV for not to be a difficult intubation.
Measured: 1 minute
Thyromental distance
measured from the thyroid notch to the tip of the jaw with the head extended
Measured: 1 minute
Sternomental distance
the distance from the suprasternal notch to the mentum and is measured with the head fully extended on the neck and the mouth closed
Measured: 1 minute
Interincisor distance
DIstance in centimeters between fornt incisors
Measured: 1 minute
Upper Lip Bite Test
upper lip bite criteria-class I = lower incisors can bite the upper lip above the vermilion line, class II = lower incisors can bite the upper lip below the vermilion line, and class III = lower incisors cannot bite the upper lip. Class I is the best for not to be a difficult intubation, class III means it´s posibble a difficult laryngoscopy.
Measured: 1 minute
neck circumference
Using a flexible measuring tape in centimeters, neck circumference at the level of thethyroid cartilage will be measured
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start1 May 2019
- Primary completion13 Jan 2020
- Study completion13 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult IntubationStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168840
- Sponsor's protocol ID
- UPDA
- Status last verified
- Jan 2020
- First submitted
- 14 Nov 2019
- Last updated
- 16 Mar 2021
- 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 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Parameters to Predict Difficult Airway
- ClinicalTrials.gov ID
- NCT04168840
- Acronym / sponsor ID
- UPDA
- Conditions
- Difficult Intubation
- Keywords
- ultrasound, difficult airway, difficult intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 13 Jan 2020 (actual)
- Study completion
- 13 Jan 2020 (actual)
- First posted
- 19 Nov 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.
Ultrasound has become an essential tool for the daily work of any doctor, but in certain specialties such as Anaesthesiology, its use has greatly increased the safety offered to patients throughout the perioperative period, either to perform nerve blocks, for vascular access, intraoperative hemodynamic management or any other use that allows increasing quality of care.
The management of the upper airway and the diagnosis of pathological conditions are essential skills for any doctor especially for Anaesthesiologist, ER physician, or Intensive Care physician. Because an inadequate airway management continues to be an important contributor to patient mortality and morbidity, any tool that can improve it should be considered as an addition to conventional clinical evaluation.
Unfortunately, most of the clinical parameters that should allow us to assess a potential difficult airway, do not always lead us to an adequate prediction, that is why US(Ultrasound) is use as an emerging tool in many fields, is also gathering strength in this search for a definitive predictor parameter.
Ultrasound has many obvious advantages (safe,fast, repeatable, portable, widely available and gives dynamic images in real time).
Sonographic studies are operator-dependent and although the identification of basic structures could be acquired with only a few hours of training, but more complex studies require a learning curve of months or even years. The high frequency linear probe (5-14 MHz) is probably the most suitable for the airway because images are of superficial structures (within 0-5 cm below the skin surface).
The growing academic interest in the use of US to look for predictors of difficult airway is centred mainly on measurements at the level of pretracheal tissues.
But the greatest limitation of these studies is the disparity of the fat distribution that exists between different ethnic groups and and sexes, and the lack of standardization method in patient´s intubation conditions.
So, the investigator propose to assess different ultrasound windows at the level of pretracheal tissues such as independent predictors of Difficult Airway.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient undergoing general anesthesia with intubation | – | Diagnostic Test: Compare clinical test with ultrasound parametersPatient undergoing general anesthesia with intubation We will explore clinical airway parameters and external ultrasound parameters of the airway |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing scheduled surgery requiring orotracheal intubation.
Key inclusion criteria (1 listed)
- Patients (male or female) ASA I-III, aged between 18 and 90 years, undergoing scheduled surgery requiring orotracheal intubation. The signature of the informed consent is required authorizing its inclusion in the study.
Key exclusion criteria (6 listed)
- Obesity class II defined as a BMI greater than 35.
- Pregnant.
- Cervical tumors, goiter or patients who have required radiotherapy at the cervical level
- Abnormalities that condition anatomy alterations such as facial / cervical fractures.
- Maxillofacial abnormalities
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 |
|---|---|---|
| Compare clinical test with ultrasound parametersCompare various clinical test with four ultrasound parameters to predict difficult intubation. | Diagnostic test | Patient undergoing general anesthesia with intubation |
Primary outcome
Anterior neck soft tissue thickness measured by ultrasound at hyoid bone
Time frame: 5 minutes
Distance from skin to the midline of hyoid bone measure with lineal ultrasound probe
Anterior neck soft tissue thickness measured by ultrasound at thyrohyoid membrane
Time frame: 5 minutes
Distance from skin to midline of epiglottis measure with lineal ultrasound probe
Anterior neck soft tissue thickness measured by ultrasound at anterior commissure of vocal cords
Time frame: 5 minutes
Distance from skin to anterior commisure of vocal cords measure with lineal ultrasound probe
Anterior neck soft tissue thickness measured by ultrasound at thyrohyoid membrane. Preepiglottic Area.
Time frame: 5 minutes
Calculated with distance from skin to midline of epiglottis and 1 centimeterto left and right side.
6 secondary outcomes
Modified Mallampati Score
Time frame: 1 minute
Thyromental distance
Time frame: 1 minute
Sternomental distance
Time frame: 1 minute
Interincisor distance
Time frame: 1 minute
Upper Lip Bite Test
Time frame: 1 minute
neck circumference
Time frame: 1 minute
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 Mar 2021.
- 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 Difficult Intubation, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
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 6 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 Mar 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 Spain. 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?
Anterior neck soft tissue thickness measured by ultrasound at hyoid bone (time frame: 5 minutes). The study lists 4 primary outcomes in all. 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 Mar 2021.