Intubation; Difficult or FailedNCT04453683
Airway Management in Morbidly Obese Patients: A Comparison of Intubating Laryngeal Mask Fastrack and Air Q as a Conduit for Fiberoptic Intubation
A study testing Air-Q. ILA insertion of proper size and ILMA insertion of proper size in people with Intubation; Difficult or Failed, run by Zagazig University at 1 site in Egypt.
Trial summary
To compare air Q versus ILMA intubation in obese adult paralyzed patient Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Intubation; Difficult or Failed
- What is being tested?
- Air-Q. ILA insertion of proper size and ILMA insertion of proper size
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2019to 20 Jun 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:All morbidly obese patient defined as BMI >40 kg/m2 scheduled for an elective surgery requiring general anesthesia with tracheal intubation were enrolled on the day of their surgery.
ASA physical status (I-II)
Exclusion Criteria physical status of IV or V or had a history of impossible tracheal intubation or awake fibreoptic intubation or if preoperative evaluation showed limited mouth aperture <3.5 cm or showed evidence that an awake fiberoptic intubation or rapid sequence induction would be required patients at increased risk for aspiration of gastric contents, coagulopathy or those with unstable cervical spines or requiring nasal route for tracheal intubation
-
Trial locations and contacts
1 site in 1 country.
About this study
To compare air Q versus ILMA intubation in obese adult paralyzed patient
Read the detailed description
Evaluate the process of endo-tracheal intubation through Air Q compared to through ILMA regarding number and duration of attempts, laryngeal view grade, time to removal of device over tube without dislodgement and any complication
- Conditions
- Intubation; Difficult or Failed
- Being tested
- Air-Q. ILA insertion of proper size, ILMA insertion of proper size
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air-Q. ILA insertion of proper sizeDevice
Success of fiberoptic guided intubation throuhgh Air Q supraglottic airway device
ILMA insertion of proper sizeDevice
Success of fiberoptic guided intubation throuhgh ILMA supraglottic airway device
| Study group | Role | What they receive |
|---|---|---|
| Group I ( Air Q) | Active comparator | nsertion of proper size Air-Q. ILA Receives: Device: Air-Q. ILA insertion of proper size |
| Group II (ILMA) | Active comparator | nsertion of proper size ILMA Receives: Device: ILMA insertion of proper size |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of tracheal intubation through each device.
success rate of tracheal intubation through each device is defined as end tidal carbon dioxide confirmed placement of TT within a maximum of 5 min tracheal intubation time
Measured: Within a maximum of 5 minutes to confirm success of tracheal intubation through each supraglottic airway devices
Secondary outcomes (1)
Insertion time of supraglottic airway devices
Time necessary for insertion was measured from the time the face mask was taken away until the appearance of Co2 on the capnograph while supraglottic airway device in place
Measured: It is about 13-19 second for insertion of supraglottic airway devices
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start20 Jun 2019
- Primary completion20 Jun 2020
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intubation; Difficult or FailedStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Heba Mohamed EL -Asser,MD, Zagazig University
- Investigators
- Heba M EL-Asser, MD, Principal investigator, Zagazig UniversityKhadiga M El Hossiney, MD, Study chair, Zagazig UniversityAmani A Aly, Study chair, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453683
- Sponsor's protocol ID
- Intubation in morbid obese
- Status last verified
- Jan 2023
- First submitted
- 28 Jun 2020
- Last updated
- 4 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frappier J, Guenoun T, Journois D, Philippe H, Aka E, Cadi P, Silleran-Chassany J, Safran D. Airway management using the intubating laryngeal mask airway for the morbidly obese patient. Anesth Analg. 2003 May;96(5):1510-1515. doi: 10.1213/01.ANE.0000057003.91393.3C.
PubMed 12707159Karim YM, Swanson DE. Comparison of blind tracheal intubation through the intubating laryngeal mask airway (LMA Fastrach) and the Air-Q. Anaesthesia. 2011 Mar;66(3):185-90. doi: 10.1111/j.1365-2044.2011.06625.x.
PubMed 21320087
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Management in Morbidly Obese Patients: A Comparison of Intubating Laryngeal Mask Fastrack and Air Q as a Conduit for Fiberoptic Intubation
- ClinicalTrials.gov ID
- NCT04453683
- Acronym / sponsor ID
- Intubation in morbid obese
- Conditions
- Intubation; Difficult or Failed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 1 Jul 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.
To compare air Q versus ILMA intubation in obese adult paralyzed patient
Detailed description
Evaluate the process of endo-tracheal intubation through Air Q compared to through ILMA regarding number and duration of attempts, laryngeal view grade, time to removal of device over tube without dislodgement and any complication
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I ( Air Q) | Active comparator | Device: Air-Q. ILA insertion of proper sizensertion of proper size Air-Q. ILA |
| Group II (ILMA) | Active comparator | Device: ILMA insertion of proper sizensertion of proper size ILMA |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Air-Q. ILA insertion of proper sizeSuccess of fiberoptic guided intubation throuhgh Air Q supraglottic airway device | Device | Group I ( Air Q) |
| ILMA insertion of proper sizeSuccess of fiberoptic guided intubation throuhgh ILMA supraglottic airway device | Device | Group II (ILMA) |
Primary outcome
success rate of tracheal intubation through each device.
Time frame: Within a maximum of 5 minutes to confirm success of tracheal intubation through each supraglottic airway devices
success rate of tracheal intubation through each device is defined as end tidal carbon dioxide confirmed placement of TT within a maximum of 5 min tracheal intubation time
1 secondary outcome
Insertion time of supraglottic airway devices
Time frame: It is about 13-19 second for insertion of supraglottic airway devices
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 4 Jan 2023.
- Background: PubMed 12707159Frappier J, Guenoun T, Journois D, Philippe H, Aka E, Cadi P, Silleran-Chassany J, Safran D. Airway management using the intubating laryngeal mask airway for the morbidly obese patient. Anesth Analg. 2003 May;96(5):1510-1515. doi: 10.1213/01.ANE.0000057003.91393.3C.
- Background: PubMed 21320087Karim YM, Swanson DE. Comparison of blind tracheal intubation through the intubating laryngeal mask airway (LMA Fastrach) and the Air-Q. Anaesthesia. 2011 Mar;66(3):185-90. doi: 10.1111/j.1365-2044.2011.06625.x.
- Individual participant dataSharing planned: No
Related trials for Intubation; Difficult or Failed
Not yet recruitingObservational study
Can the "Face Index"; an Anthropometric Measurement, Predict Difficult Laryngoscopy and Intubation?
Anesthesia Intubation Complication, Laryngoscopy
RecruitingObservational study
PrediSuisse: Automatized Assessment of Difficult Airway
Anesthesia, Intubation; Difficult or Failed
RecruitingObservational study
Difficult Airway Prediction by Integrating STOP-BANG Criteria
Ventilatory Defect, Intubation; Difficult or Failed
RecruitingObservational study
Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
Failed or Difficult Intubation, Sequela, Intubation; Difficult
Active, not recruitingObservational study
Data-driven Development of a Core Dataset for Difficult Airway Alerts
Airway Management, Intubation; Difficult or Failed
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.
Heba M EL-Asser, MD principal investigator
Zagazig University
Khadiga M El Hossiney, MD study chair
Zagazig University
Amani A Aly study chair
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air-Q. ILA insertion of proper size and ILMA insertion of proper size in people with Intubation; Difficult or Failed, run by Zagazig 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?
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 4 Jan 2023. 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?
success rate of tracheal intubation through each device. (time frame: Within a maximum of 5 minutes to confirm success of tracheal intubation through each supraglottic airway devices). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04453683, which also lists 2 linked publications.
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 4 Jan 2023.