Difficult IntubationNCT03799055
Ultrasonography vs Conventional Methods for Prediction of Difficult Airway in Adult Patients
An observational study of Difficult Intubation, run by Benha University at 1 site in Egypt.
Trial summary
The aim of this study to assess and compare between methods of prediction of difficult airway including Mallmpati score , thyromental distance and us measured distance from skin to epiglottis(DES) t the level of thyrohyoid membrane in adult patients requiring endotracheal intubation for an elective surgical procedure. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Difficult Intubation
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2019to 10 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients at Benha University Surgical Hospital scheduled for elective surgical procedures requiring endotracheal tube
Who may be able to join
- American Society of Anaesthesia class 1,2and 3.
- elective surgical procedure requiring endotracheal intubation.
- Age 18_60 years old.
- BMI less than 40kg/meter square.
Who cannot join
- patients refusal.
- Unable to give consent.
- Preexisting airway malformations or pathology.
- History of difficult intubation.
- Pregnancy.
- Patients with tracheostomy tube.
- BMI more than 40 kg/meter square.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonography(Distance From Skin to Epiglottis) vs Conventional Methods (Mallampati Score & Thyromental Distance) for Prediction of Difficult Airway in Adult Patients
The aim of this study to assess and compare between methods of prediction of difficult airway including Mallmpati score , thyromental distance and us measured distance from skin to epiglottis(DES) t the level of thyrohyoid membrane in adult patients requiring endotracheal intubation for an elective surgical procedure.
- Conditions
- Difficult Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| easy intubation | Cormack _Lehane : 1\&2 | |
| difficult intubation | Cormack _Lehane : 3\&4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of difficult airway
Assess which method is better for prediction of difficult airway DES or conventional
Measured: Preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start10 Jun 2019
- Primary completion29 Dec 2019
- Study completion10 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.
- More trials run by Benha 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
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baher Said Elshahat Mohamed Abdelhady, Benha University
- Investigators
- Faculty Of Medicine, Study director, faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799055
- Sponsor's protocol ID
- Us in difficult airway
- Status last verified
- Apr 2020
- First submitted
- 8 Jan 2019
- Last updated
- 22 Apr 2020
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonography(Distance From Skin to Epiglottis) vs Conventional Methods (Mallampati Score & Thyromental Distance) for Prediction of Difficult Airway in Adult Patients
- ClinicalTrials.gov ID
- NCT03799055
- Acronym / sponsor ID
- Us in difficult airway
- Conditions
- Difficult Intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 29 Dec 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 10 Jan 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 to assess and compare between methods of prediction of difficult airway including Mallmpati score , thyromental distance and us measured distance from skin to epiglottis(DES) t the level of thyrohyoid membrane in adult patients requiring endotracheal intubation for an elective surgical procedure.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| easy intubation | – | –Cormack _Lehane : 1\&2 |
| difficult intubation | – | –Cormack _Lehane : 3\&4 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients at Benha University Surgical Hospital scheduled for elective surgical procedures requiring endotracheal tube
Key inclusion criteria (4 listed)
- American Society of Anaesthesia class 1,2and 3.
- elective surgical procedure requiring endotracheal intubation.
- Age 18_60 years old.
- BMI less than 40kg/meter square.
Key exclusion criteria (7 listed)
- patients refusal.
- Unable to give consent.
- Preexisting airway malformations or pathology.
- History of difficult intubation.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prediction of difficult airway
Time frame: Preoperative
Assess which method is better for prediction of difficult airway DES or conventional
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 22 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Difficult Intubation
Enrolling by invitation
Pediatric Intubation Simulations With Bougie
Difficult Airway Intubation
Not yet recruitingObservational study
Sniper Intubation for Training of Undergraduate Medical Student
Intubation;Difficult
RecruitingObservational study
Airway Ultrasound in Oncologic Maxillofacial Patients
Head and Neck Cancer
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation
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.
Faculty Of Medicine study director
faculty of medicine
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 Benha 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 4 inclusion and 7 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 22 Apr 2020. 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?
Prediction of difficult airway (time frame: Preoperative). 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 Apr 2020.