Preoperative Ultrasound Assessment of the Upper Airway Can Predict Difficult Laryngscopy in Obese at Emergency OperationsNCT05109221
Ultrasonography in Predicting Difficult Intubation in Obese Emergency Surgical Patients
An observational study of Preoperative Ultrasound Assessment of the Upper Airway Can Predict Difficult Laryngscopy in Obese at Emergency Operations, run by Minia University at 1 site in Egypt.
Trial summary
Validity of ultrasonography in predicting difficult laryngoscopy and confirming endotracheal intubation in obese emergency surgical patients Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Preoperative Ultrasound Assessment of the Upper Airway Can Predict Difficult Laryngscopy in Obese at Emergency Operations
- What is being tested?
- ultrasound
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 30 Oct 2022
- How long will I take part?
- 1 Day
- 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
- Adult
Study population: obese emergency surgical patients
Who may be able to join
- Adult obese patients (BMI>35) of both sex aged from 18 to 60 years undergoing urgent surgeries under general anasthesia with tracheal intubation.
Who cannot join
- . Patients with removable upper dentures, upper airway pathology, cervical spine fractures, full stomach, maxillofacial trauma or unstable patients and pregnant women will be excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity of Ultrasonography in Predicting Difficult Laryngoscopy and Confirming Endotracheal Intubation in Obese Emergency Surgical Patients
Validity of ultrasonography in predicting difficult laryngoscopy and confirming endotracheal intubation in obese emergency surgical patients
Read the detailed description
The aim of the study is to determine whether preoperative ultrasound assessment of of the upper airway can predict difficult laryngscopy in emergency surgical obese patients , by analysis correlations between ultrasound measurements of anterior cervical soft in the upper airway, and the Cormack-Lehane grade. And evaluate its role in confirming the endotracheal placement The secondary objective was to determine whether clinical screening tests are independent predictors of difficult airway.
- Being tested
- ultrasound
- Keywords
- ultrasound _difficult intubation _obese _emergency operations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
using of ultrasound in prediction of difficult intubation in obese surgical patients
What is being measured
The primary outcome is the main question the study is designed to answer.
prediction of difficult intubation in obese emergency surgical patients by ultrasound
determine whether preoperative ultrasound assessment of of the upper airway can predict difficult laryngscopy in emergency surgical obese patients , by analysis correlations between ultrasound measurements of anterior cervical soft in the upper airway, and the Cormack-Lehane grade. And evaluate its role in confirming the endotracheal placement
Measured: 30minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start1 Dec 2021
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative Ultrasound Assessment of the Upper Airway Can Predict Difficult Laryngscopy in Obese at Emergency OperationsStudies of the same condition, open and under way.
- More trials run by Minia 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hemmat Amer Mohamed, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109221
- Sponsor's protocol ID
- 99_2021
- Status last verified
- Sep 2022
- First submitted
- 26 Oct 2021
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Ultrasonography in Predicting Difficult Laryngoscopy and Confirming Endotracheal Intubation in Obese Emergency Surgical Patients
- ClinicalTrials.gov ID
- NCT05109221
- Acronym / sponsor ID
- 99_2021
- Keywords
- ultrasound _difficult intubation _obese _emergency operations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 5 Nov 2021 (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.
Validity of ultrasonography in predicting difficult laryngoscopy and confirming endotracheal intubation in obese emergency surgical patients
Detailed description
The aim of the study is to determine whether preoperative ultrasound assessment of of the upper airway can predict difficult laryngscopy in emergency surgical obese patients , by analysis correlations between ultrasound measurements of anterior cervical soft in the upper airway, and the Cormack-Lehane grade. And evaluate its role in confirming the endotracheal placement The secondary objective was to determine whether clinical screening tests are independent predictors of difficult airway.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- obese emergency surgical patients
Key inclusion criteria (1 listed)
- Adult obese patients (BMI>35) of both sex aged from 18 to 60 years undergoing urgent surgeries under general anasthesia with tracheal intubation.
Key exclusion criteria (1 listed)
- . Patients with removable upper dentures, upper airway pathology, cervical spine fractures, full stomach, maxillofacial trauma or unstable patients and pregnant women will be excluded from the 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 |
|---|---|---|
| ultrasoundusing of ultrasound in prediction of difficult intubation in obese surgical patients | Device | – |
Primary outcome
prediction of difficult intubation in obese emergency surgical patients by ultrasound
Time frame: 30minutes
determine whether preoperative ultrasound assessment of of the upper airway can predict difficult laryngscopy in emergency surgical obese patients , by analysis correlations between ultrasound measurements of anterior cervical soft in the upper airway, and the Cormack-Lehane grade. And evaluate its role in confirming the endotracheal placement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Individual participant dataSharing planned: Yes
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 Preoperative Ultrasound Assessment of the Upper Airway Can Predict Difficult Laryngscopy in Obese at Emergency Operations, run by Minia 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: status not confirmed, as of the sponsor's last update on 15 Sep 2022. 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?
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?
prediction of difficult intubation in obese emergency surgical patients by ultrasound (time frame: 30minutes). 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 15 Sep 2022.