LMA Vs I GelNCT03843827
Randomized Comparative Study Between Classic Laryngeal Mask Airway and I Gel Airway in Obese Patients Having BMI 35-40 During Elective Non Abdominal Surgery.
A study testing Laryngeal Mask Airway and I gel Airway in people with LMA Vs I Gel, run by Cairo University at 1 site in Egypt.
Trial summary
Invistigators study both supraglottic airway devices; the classic LMA and the I GEL mask are satisfactory devices providing high airway leaking pressures. Although both devices provide high airway leaking pressures, Invistigators study revealed that the I gel mask provides a better seal with the glottic aperture and… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- LMA Vs I Gel
- What is being tested?
- Laryngeal Mask Airway and I gel Airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Mar 2019to 18 May 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult healthy ASA II patients
- both genders
- BMI 35-40
- aged 18 - 60 years
- Mallampati grade I, II with airway score < 4 according to El Ganzouri score during elective non abdominal surgery ≤ 2hour e.g diagnostic arthroscopy, hysteroscopy and cataract
Who cannot join
- ASA class III or IV
- Age >60 years or <18 years,
- people with hypertension, diabetes, pregnancy, gastro oesophageal reflux disease, cardiovascular ,renal disease4. difficult mask ventilation , obstructive sleep apnea ,any position rather than supine , airway score ≥ 4 according to El Ganzouri score
- 5. any form of sore throat ,patients allergic to any drugs used in the study 6. PCV mode if measured tidal volume was lesser than 6 ml/kg it will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Invistigators study both supraglottic airway devices; the classic LMA and the I GEL mask are satisfactory devices providing high airway leaking pressures. Although both devices provide high airway leaking pressures, Invistigators study revealed that the I gel mask provides a better seal with the glottic aperture and shorter time of insertion than cLMA. Both devices showed also effective ventilation, more hemodynamic stability and no episode of hypoxia with minimal post-operative complications.
Read the detailed description
Because of the advantages of supraglottic devices over the conventional endotracheal intubation, they are now widely used in ventilation. The classic LMA is a first generation simple airway tube consists of two parts, the tube and the cuffed peri-laryngeal sealer mask which is designed to provide an oval seal around the laryngeal inlet. It is made of medical grade silicone; it can be autoclaved and reused many times. I gel is a new type of laryngeal mask and doesn't have an inflatable cuff. Because of its thermoplastic elastomer structure, it exactly adapts to the supraglottic tissue by binding with body temperature, thus minimising air leakage. The aim of this study is to compare between cLMA and I gel regarding insertion success rate, the time of insertion, leaking pressure, assessment of position by fiber optic, hemodynamic, Spo2 for each device during insertion and maintenance of general anaesthesia and postoperative complications in obese patients. This study was conducted in Kasr Al-Ainy Teaching Hospital, after obtaining approval from Kasr Al-Ainy hospital research ethical committee, written informed consents were taken from 50 patients, all of whom completed this study. Patients were randomly allocated into 2 equal groups, 25 each, according to the inclusion and exclusion criteria.
- GA (n=25) in which classic laryngeal mask was used for ventilation.
- GB (n=25) in which I gel was used for ventilation. In our study the median insertion time was in I gel lesser than cLMA (9 s vs 10 s) respectively that was statistically significant but clinically insignificance. Higher leaking pressure was in I gel group (25cmh2o vs 18cmh2o) than cLMA group that was statistically significant. Our main finding in the study was that both supraglottic airway devices; the classic LMA and the I GEL mask are satisfactory devices providing high airway leaking pressures. Although both devices provide high airway leaking pressures, our study revealed that the I gel mask provides a better seal with the glottic aperture and shorter time of insertion than cLMA. Both devices showed also effective ventilation, more hemodynamic stability and no episode of hypoxia with minimal postoperative complications.
- Conditions
- LMA Vs I Gel
- Being tested
- Laryngeal Mask Airway, I gel Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal Mask AirwayDevice
The aim of this study is to compare between cLMA and I gel regarding insertion success rate, the time of insertion, leaking pressure, assessment of position by fiber optic, hemodynamic, Spo2 for each device during insertion and maintenance of general anaesthesia and postoperative complications in obese patients
I gel AirwayDevice
I gel is a new type of laryngeal mask and doesn't have an inflatable cuff. Because of its thermoplastic elastomer structure, it exactly adapts to the supraglottic tissue by binding with body temperature, thus minimising air leakage
| Study group | Role | What they receive |
|---|---|---|
| Group A (LMA Group) | Active comparator | Active Comparator: Group A (LMA Group) LMA-Classic™ laryngeal mask airway (Classic™LMA) by Dr. Archie Brain into clinical practice in 1988 brought about a revolution in anesthesia. In the literature, there are over 2,500 studies supporting Classic™ LMA usage. Following the success and popularity of Classic™ LMA, many different variants of this device have been designed and marketed,trying to offer a simple and effective alternative to the endotracheal intubation. Receives: Device: Laryngeal Mask Airway |
| Group B (I gel Group) | Active comparator | I gel is a new type of laryngeal mask and doesn't have an inflatable cuff. Because of its thermoplastic elastomer structure, it exactly adapts to the supraglottic tissue by binding with body temperature,thus minimising air leakage Receives: Device: I gel Airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of insertion of each device .
Invistigators study Time of insertion of each device,Laryngeal Mask Airway and I gel
Measured: Half an hour
Secondary outcomes (6)
Leaking pressure of each device.
Invistigators study Leaking pressure of each device,Laryngeal Mask Airway and I gel
Measured: Half an hour
Confirmation of position by fiber optic
Invistigators study Confirmation of position by fiber optic of each device,Laryngeal Mask Airway and I gel
Measured: Half an hour
Blood Pressure
Investigators recorded a baseline reading of systolic blood pressure and diastolic blood pressure before insertion of both devices. A second reading was taken after insertion of both devices, just before removal. The fourth reading was recorded 1 min after removal of both devices.
Measured: 24 hours
Heart Rate
Investigators recorded a baseline reading of heart rate, before insertion of both devices. A second reading was taken after insertion of both devices, just before removal. The fourth reading was recorded 1 min after removal of both devices.
Measured: 24 hours
Oxygen saturation
Investigators recorded a baseline reading of Oxygen saturation before insertion of both devices. A second reading was taken after insertion of both devices, just before removal. The fourth reading was recorded 1 min after removal of both devices.
Measured: 24 hours
Postoperative complications
With regard to postoperative complications, after removal of the device, post operative blood stain in laryngeal mask and I gel
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start9 Mar 2019
- Primary completion15 May 2019
- Study completion18 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LMA Vs I GelStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigators hypothesize that both supraglottic devices, the classic LMA and i gel are effective in ventilation of obese patient.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdalla, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843827
- Sponsor's protocol ID
- N 34-2017/Ms
- Status last verified
- May 2019
- First submitted
- 8 Feb 2019
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not Now
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparative Study Between Classic Laryngeal Mask Airway and I Gel Airway in Obese Patients Having BMI 35-40 During Elective Non Abdominal Surgery.
- ClinicalTrials.gov ID
- NCT03843827
- Acronym / sponsor ID
- N 34-2017/Ms
- Conditions
- LMA Vs I Gel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 9 Mar 2019 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 18 May 2019 (actual)
- First posted
- 18 Feb 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.
Invistigators study both supraglottic airway devices; the classic LMA and the I GEL mask are satisfactory devices providing high airway leaking pressures. Although both devices provide high airway leaking pressures, Invistigators study revealed that the I gel mask provides a better seal with the glottic aperture and shorter time of insertion than cLMA. Both devices showed also effective ventilation, more hemodynamic stability and no episode of hypoxia with minimal post-operative complications.
Detailed description
Because of the advantages of supraglottic devices over the conventional endotracheal intubation, they are now widely used in ventilation. The classic LMA is a first generation simple airway tube consists of two parts, the tube and the cuffed peri-laryngeal sealer mask which is designed to provide an oval seal around the laryngeal inlet. It is made of medical grade silicone; it can be autoclaved and reused many times. I gel is a new type of laryngeal mask and doesn't have an inflatable cuff. Because of its thermoplastic elastomer structure, it exactly adapts to the supraglottic tissue by binding with body temperature, thus minimising air leakage. The aim of this study is to compare between cLMA and I gel regarding insertion success rate, the time of insertion, leaking pressure, assessment of position by fiber optic, hemodynamic, Spo2 for each device during insertion and maintenance of general anaesthesia and postoperative complications in obese patients. This study was conducted in Kasr Al-Ainy Teaching Hospital, after obtaining approval from Kasr Al-Ainy hospital research ethical committee, written informed consents were taken from 50 patients, all of whom completed this study. Patients were randomly allocated into 2 equal groups, 25 each, according to the inclusion and exclusion criteria.
- GA (n=25) in which classic laryngeal mask was used for ventilation.
- GB (n=25) in which I gel was used for ventilation. In our study the median insertion time was in I gel lesser than cLMA (9 s vs 10 s) respectively that was statistically significant but clinically insignificance. Higher leaking pressure was in I gel group (25cmh2o vs 18cmh2o) than cLMA group that was statistically significant. Our main finding in the study was that both supraglottic airway devices; the classic LMA and the I GEL mask are satisfactory devices providing high airway leaking pressures. Although both devices provide high airway leaking pressures, our study revealed that the I gel mask provides a better seal with the glottic aperture and shorter time of insertion than cLMA. Both devices showed also effective ventilation, more hemodynamic stability and no episode of hypoxia with minimal postoperative complications.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Investigators hypothesize that both supraglottic devices, the classic LMA and i gel are effective in ventilation of obese patient.
| Arm | Type | Receives |
|---|---|---|
| Group A (LMA Group) | Active comparator | Device: Laryngeal Mask AirwayActive Comparator: Group A (LMA Group) LMA-Classic™ laryngeal mask airway (Classic™LMA) by Dr. Archie Brain into clinical practice in 1988 brought about a revolution in anesthesia. In the literature, there are over 2,500 studies supporting Classic™ LMA usage. Following the success and popularity of Classic™ LMA, many different variants of this device have been designed and marketed,trying to offer a simple and effective alternative to the endotracheal intubation. |
| Group B (I gel Group) | Active comparator | Device: I gel AirwayI gel is a new type of laryngeal mask and doesn't have an inflatable cuff. Because of its thermoplastic elastomer structure, it exactly adapts to the supraglottic tissue by binding with body temperature,thus minimising air leakage |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult healthy ASA II patients
- both genders
- BMI 35-40
- aged 18 - 60 years
- Mallampati grade I, II with airway score < 4 according to El Ganzouri score during elective non abdominal surgery ≤ 2hour e.g diagnostic arthroscopy, hysteroscopy and cataract
Key exclusion criteria (4 listed)
- ASA class III or IV
- Age >60 years or <18 years,
- people with hypertension, diabetes, pregnancy, gastro oesophageal reflux disease, cardiovascular ,renal disease4. difficult mask ventilation , obstructive sleep apnea ,any position rather than supine , airway score ≥ 4 according to El Ganzouri score
- 5. any form of sore throat ,patients allergic to any drugs used in the study 6. PCV mode if measured tidal volume was lesser than 6 ml/kg it will be excluded.
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 AirwayThe aim of this study is to compare between cLMA and I gel regarding insertion success rate, the time of insertion, leaking pressure, assessment of position by fiber optic, hemodynamic, Spo2 for each device during insertion and maintenance of general anaesthesia and postoperative complications in obese patients | Device | Group A (LMA Group) |
| I gel AirwayI gel is a new type of laryngeal mask and doesn't have an inflatable cuff. Because of its thermoplastic elastomer structure, it exactly adapts to the supraglottic tissue by binding with body temperature, thus minimising air leakage | Device | Group B (I gel Group) |
Primary outcome
Time of insertion of each device .
Time frame: Half an hour
Invistigators study Time of insertion of each device,Laryngeal Mask Airway and I gel
6 secondary outcomes
Leaking pressure of each device.
Time frame: Half an hour
Confirmation of position by fiber optic
Time frame: Half an hour
Blood Pressure
Time frame: 24 hours
Heart Rate
Time frame: 24 hours
Oxygen saturation
Time frame: 24 hours
Postoperative complications
Time frame: 24 hours
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 21 May 2019.
- Individual participant dataSharing planned: Undecided. Not Now
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 I gel Airway in people with LMA Vs I Gel, run by Cairo 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 5 inclusion and 4 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 21 May 2019. 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 of insertion of each device . (time frame: Half an hour). 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 21 May 2019.