Bariatric Surgery CandidateNCT04378192
Laryngeal Mask Airway as a Bridge for Intubation of Obese Patients for Sleeve Gastrectomy
A study testing Laryngeal mask airway and face mask in people with Bariatric Surgery Candidate, run by Suez Canal University at 1 site in Egypt.
Trial summary
Ventilation, as well as intubation of a morbidly obese patient, is challenging and require special preparations and skilful hands, in this study laryngeal mask airway insertion is used as a bridge for intubation to facilitate ventilation as give enough time to anaesthetics and muscle relaxants to work on. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Laryngeal mask airway and face mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 30 Jan 2022
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Morbid obese patient BMI>40
- ASA I, II, III
- Elective sleeve gastrectomy
Who cannot join
- Oral cavity infection or pathological abnormalities
- Suspected or known abnormalities in supraglottic anatomy
- Patients planned for awake fiberoptic intubation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Use of Laryngeal Mask Airway as Abridge for Intubation of Morbidly Obese Patients Undergoing Sleeve Gastrectomy
Ventilation, as well as intubation of a morbidly obese patient, is challenging and require special preparations and skilful hands, in this study laryngeal mask airway insertion is used as a bridge for intubation to facilitate ventilation as give enough time to anaesthetics and muscle relaxants to work on.
Read the detailed description
The ordinary pathway of intubating a morbidly obese patient for sleeve gastrectomy is bordered by the risk of difficult ventilation and intubation with the subsequent events of hypoxia and hypoventilation. When the patient is easy ventilated, it gives some sort of confidence and pleasure for the anaesthetist that the way of intubation will not be so hard.
One problem here is the difficulty of ventilating a morbidly obese patient, in this study the investigators used laryngeal mask airway as a bridge before inserting the endotracheal tube
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Laryngeal mask airway, face mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal mask airwayDevice
Also called LMA
Insertion of laryngeal mask airway before intubation of a morbidly obese patient
face maskDevice
use of face mask before intubation of a morbidly obese patient
| Study group | Role | What they receive |
|---|---|---|
| Face mask ventilation | Active comparator | Use of face mask ventilation technique after induction of anaesthesia and administration pf muscle relaxant till the insertion of the endotracheal tube in a morbidly obese patient undergoing sleeve gastrectomy Receives: Device: face mask |
| Laryngeal mask ventilation | Active comparator | Use of laryngeal mask airway LMA for ventilation after induction of anaesthesia and administration pf muscle relaxant till the insertion of the endotracheal tube in a morbidly obese patient undergoing sleeve gastrectomy Receives: Device: Laryngeal mask airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to intubation TTI
The time starts with insertion of glidescop and ends at its withdrawal
Measured: During the action of intubation after induction of anaesthesia
Secondary outcomes (5)
View of the glottis
Based on the percentage of glottic opening (POGO) score as well as Cormack and Lehane's (C\&L) classification
Measured: During the action of intubation after induction of anaesthesia
Number of attempts required for intubation,
How many times the anaesthetist needs to try to succeed in insertion of the endotracheal tube
Measured: During the action of intubation after induction of anaesthesia
Anaesthetist's satisfaction score
On a scale rang from 0 representing totally dissatisfied to 10 representing fully satisfied
Measured: During the action of intubation after induction of anaesthesia
Intubation difficulty score (IDS)
Intubation difficulty score (IDS) is the sum of seven variables, each presents 1 point, score 0 represents easy intubation, score 1 to 5 represents moderate difficulty and score more than 5 was considered difficult intubation.
Measured: During the action of intubation after induction of anaesthesia
Need for external pressure during intubation
to direct the larynx downward to facilitate endotracheal intubation
Measured: During the action of intubation after induction of anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start1 Feb 2019
- Primary completion30 Aug 2021
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhman Alshawadfy, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378192
- Sponsor's protocol ID
- LMA obesity
- Status last verified
- May 2026
- First submitted
- 4 May 2020
- Last updated
- 26 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Use of Laryngeal Mask Airway as Abridge for Intubation of Morbidly Obese Patients Undergoing Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT04378192
- Acronym / sponsor ID
- LMA obesity
- Conditions
- Bariatric Surgery Candidate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 7 May 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.
Ventilation, as well as intubation of a morbidly obese patient, is challenging and require special preparations and skilful hands, in this study laryngeal mask airway insertion is used as a bridge for intubation to facilitate ventilation as give enough time to anaesthetics and muscle relaxants to work on.
Detailed description
The ordinary pathway of intubating a morbidly obese patient for sleeve gastrectomy is bordered by the risk of difficult ventilation and intubation with the subsequent events of hypoxia and hypoventilation. When the patient is easy ventilated, it gives some sort of confidence and pleasure for the anaesthetist that the way of intubation will not be so hard.
One problem here is the difficulty of ventilating a morbidly obese patient, in this study the investigators used laryngeal mask airway as a bridge before inserting the endotracheal tube
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Face mask ventilation | Active comparator | Device: face maskUse of face mask ventilation technique after induction of anaesthesia and administration pf muscle relaxant till the insertion of the endotracheal tube in a morbidly obese patient undergoing sleeve gastrectomy |
| Laryngeal mask ventilation | Active comparator | Device: Laryngeal mask airwayUse of laryngeal mask airway LMA for ventilation after induction of anaesthesia and administration pf muscle relaxant till the insertion of the endotracheal tube in a morbidly obese patient undergoing sleeve gastrectomy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Morbid obese patient BMI>40
- ASA I, II, III
- Elective sleeve gastrectomy
Key exclusion criteria (3 listed)
- Oral cavity infection or pathological abnormalities
- Suspected or known abnormalities in supraglottic anatomy
- Patients planned for awake fiberoptic intubation
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 |
|---|---|---|
| Laryngeal mask airwayAlso: LMAInsertion of laryngeal mask airway before intubation of a morbidly obese patient | Device | Laryngeal mask ventilation |
| face maskuse of face mask before intubation of a morbidly obese patient | Device | Face mask ventilation |
Primary outcome
Time to intubation TTI
Time frame: During the action of intubation after induction of anaesthesia
The time starts with insertion of glidescop and ends at its withdrawal
5 secondary outcomes
View of the glottis
Time frame: During the action of intubation after induction of anaesthesia
Number of attempts required for intubation,
Time frame: During the action of intubation after induction of anaesthesia
Anaesthetist's satisfaction score
Time frame: During the action of intubation after induction of anaesthesia
Intubation difficulty score (IDS)
Time frame: During the action of intubation after induction of anaesthesia
Need for external pressure during intubation
Time frame: During the action of intubation after induction of anaesthesia
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 26 May 2026.
- Individual participant dataSharing planned: No
Related trials for Bariatric Surgery Candidate
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
Active, not recruiting
Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients
Recruitment, Bariatric Surgery Candidate
RecruitingObservational study
Blood Collection Biorepository for Liver Disease Research
Non-Alcoholic Steatohepatitis(NASH), Hepatitis C
Enrolling by invitationObservational study
Dietary Sugar Absorptive Phenotype for Prediction of Weight Loss Outcome
Obese, Healthy
Active, not recruiting
Evaluation of the Stress Response in Bariatric Surgery With and Without the Use of Opioids
Opioid Use, Unspecified, Bariatric Surgery Candidate
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?
A study testing Laryngeal mask airway and face mask in people with Bariatric Surgery Candidate, run by Suez Canal 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 3 inclusion and 3 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 26 May 2026. 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?
Time to intubation TTI (time frame: During the action of intubation after induction of anaesthesia). 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 26 May 2026.