Difficult Airway IntubationNCT04524546
Sternomental Displacement Test for Predicting Difficult Airway in Obese Patients
An observational study of Difficult Airway Intubation, run by Cairo University at 1 site in Egypt.
Trial summary
Difficulties airway significantly contribute to the morbidity and mortality associated with anesthesia. Identifying situations and patients at risk for airway management problems is the key to optimal care and has been the focus of numerous publications. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Difficult Airway Intubation
- What is being tested?
- Sterno-mental displacement test
- How many people
- 135 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 30 Apr 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients of either sex, aged between 18-60 years old, ASA physical status II \& III with BMI > 30 Kg/m2
Who may be able to join
- Patients of either sex, aged between 18-60 years old, ASA physical status II \& III with BMI > 30 Kg/m2 undergoing elective surgical procedures under general anesthesia using endotracheal intubation by conventional laryngoscopy.
Who cannot join
- neuromuscular disorders, craniofacial abnormalities, abnormal dentition, lesions or scares in head and neck limiting the neck mobility, uncooperative, who needed awake intubation and patients who underwent emergency operations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sternomental Displacement and Neck Circumference as Predictors of Difficult Airway in Obese Patients During General Anesthesia: a Prospective Observational Cohort Study
Difficulties airway significantly contribute to the morbidity and mortality associated with anesthesia. Identifying situations and patients at risk for airway management problems is the key to optimal care and has been the focus of numerous publications. Although controversial, Body Mass Index (BMI) is considered as associated with difficult intubation in both and operating theaters. A modified measurement of SMD is obtained with the head in neutral position (SMD neutral), then the difference between SMD extension and SMD neutral was calculated and it was referred to as sternomental displacement (SMDD). SMDD was proved to be a good objective predictor for difficult laryngoscopy in adult patients, and its predictive ability was increased when combined with other tests as neck circumference (NC). To the best of our knowledge, the validity of the SMDD test was not previously assessed in obese patients.
- Conditions
- Difficult Airway Intubation
- Being tested
- Sterno-mental displacement test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterno-mental displacement testDiagnostic test
While the patient is in sitting position, (SMD neutral) will be is measured using tape as the distance between upper borders of the manubrium sterni to the mentum with the head in a neutral position. The (SMD extension) will be then measured in the same way with the head extended on the neck. The difference between SMD extension and SMD neutral will be then calculated as sternomental displacement (SMDD).
What is being measured
The primary outcome is the main question the study is designed to answer.
A a cut-off value, sensitivity (Sn), specificity (Sp), positive predictive values (PPV), negative predictive values (NPV) of sternomental displacement in predicting difficult laryngoscopy in obese patient undergoing GA.
Measured: before 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 posted24 Aug 2020
- Study start1 Sep 2020
- Primary completion20 Feb 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult Airway IntubationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Ahmed, MD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524546
- Sponsor's protocol ID
- Ms-141-2020
- Status last verified
- May 2021
- First submitted
- 20 Aug 2020
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sternomental Displacement and Neck Circumference as Predictors of Difficult Airway in Obese Patients During General Anesthesia: a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04524546
- Acronym / sponsor ID
- Ms-141-2020
- Conditions
- Difficult Airway Intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 20 Feb 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 24 Aug 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.
Difficulties airway significantly contribute to the morbidity and mortality associated with anesthesia. Identifying situations and patients at risk for airway management problems is the key to optimal care and has been the focus of numerous publications. Although controversial, Body Mass Index (BMI) is considered as associated with difficult intubation in both and operating theaters. A modified measurement of SMD is obtained with the head in neutral position (SMD neutral), then the difference between SMD extension and SMD neutral was calculated and it was referred to as sternomental displacement (SMDD). SMDD was proved to be a good objective predictor for difficult laryngoscopy in adult patients, and its predictive ability was increased when combined with other tests as neck circumference (NC). To the best of our knowledge, the validity of the SMDD test was not previously assessed in obese patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients of either sex, aged between 18-60 years old, ASA physical status II \& III with BMI > 30 Kg/m2
Key inclusion criteria (1 listed)
- Patients of either sex, aged between 18-60 years old, ASA physical status II \& III with BMI > 30 Kg/m2 undergoing elective surgical procedures under general anesthesia using endotracheal intubation by conventional laryngoscopy.
Key exclusion criteria (1 listed)
- neuromuscular disorders, craniofacial abnormalities, abnormal dentition, lesions or scares in head and neck limiting the neck mobility, uncooperative, who needed awake intubation and patients who underwent 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 |
|---|---|---|
| Sterno-mental displacement testWhile the patient is in sitting position, (SMD neutral) will be is measured using tape as the distance between upper borders of the manubrium sterni to the mentum with the head in a neutral position. The (SMD extension) will be then measured in the same way with the head extended on the neck. The difference between SMD extension and SMD neutral will be then calculated as sternomental displacement (SMDD). | Diagnostic test | – |
Primary outcome
A a cut-off value, sensitivity (Sn), specificity (Sp), positive predictive values (PPV), negative predictive values (NPV) of sternomental displacement in predicting difficult laryngoscopy in obese patient undergoing GA.
Time frame: before 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 18 May 2021.
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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 Airway Intubation, 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 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: finished, as of the sponsor's last update on 18 May 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?
A a cut-off value, sensitivity (Sn), specificity (Sp), positive predictive values (PPV), negative predictive values (NPV) of sternomental displacement in predicting difficult laryngoscopy in obese patient undergoing GA. (time frame: before 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 18 May 2021.