General Anesthesia of Morbid Obese PatientsAiUsNCT02766504
Ultrasound in Airway Assessment of Morbidly Obese Patients
An observational study of General Anesthesia of Morbid Obese Patients, run by Mansoura University at 1 site in Egypt.
Trial summary
the study aims to evaluate the role of airway ultrasound as a new evolving modality in assessment and management of airway in surgical patients Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- General Anesthesia of Morbid Obese Patients
- What is being tested?
- airway ultrasound
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2015to Jun 2016
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: surgical list patients with indicated endotracheal tube insertion for general anesthesia
Who may be able to join
- all surgical list patients planned for general anesthesia from october 2015 to may 2016
Who cannot join
- Patient refusal
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura university
Al Mansurah, Dkahleya
Alreafey Kandeel, MD, 00201008158591, refa3ey2@yahoo.com
About this study
the study aims to evaluate the role of airway ultrasound as a new evolving modality in assessment and management of airway in surgical patients
- Being tested
- airway ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
airway ultrasoundDevice
airway assessment using ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
prediction of difficult intubation in morbid obese patients
prediction of difficult intubation in morbid obese versus traditional airway scores; Mallampati score.
Measured: during endotracheal tube insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startOct 2015
- Primary completionMay 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Anesthesia of Morbid Obese PatientsStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AlRefaey Kandeel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766504
- Sponsor's protocol ID
- refa 7 105
- Acronym
- AiUs
- Status last verified
- May 2016
- First submitted
- 3 Oct 2015
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound in Airway Assessment of Morbidly Obese Patients
- ClinicalTrials.gov ID
- NCT02766504
- Acronym / sponsor ID
- AiUs / refa 7 105
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 9 May 2016 (estimated)
- 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 study aims to evaluate the role of airway ultrasound as a new evolving modality in assessment and management of airway in surgical patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- surgical list patients with indicated endotracheal tube insertion for general anesthesia
Key inclusion criteria (1 listed)
- all surgical list patients planned for general anesthesia from october 2015 to may 2016
Key exclusion criteria (1 listed)
- Patient refusal
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 |
|---|---|---|
| airway ultrasoundairway assessment using ultrasound | Device | – |
Primary outcome
prediction of difficult intubation in morbid obese patients
Time frame: during endotracheal tube insertion
prediction of difficult intubation in morbid obese versus traditional airway scores; Mallampati score.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
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.
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 General Anesthesia of Morbid Obese Patients, run by Mansoura 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 9 May 2016. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prediction of difficult intubation in morbid obese patients (time frame: during endotracheal tube insertion). 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 9 May 2016.