Morbid ObesityNCT04243564
Laryngeal Mask in Morbid Obesity
A study testing Supraglottic device (SGD) in people with Morbid Obesity, run by University of Padova at 1 site in Italy.
Trial summary
Investigators study the performance of both masks, Proseal Laryngeal Mask Airway (PLMA) and I-gel, as temporary ventilatory supraglottic airway devices (SGDs) before tracheal intubation in morbidly obese patients. Data are lacking in such population of patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Supraglottic device (SGD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 15 Feb 2021to 15 Jun 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- morbidly obese patients scheduled for elective bariatric surgery under general anesthesia
Who cannot join
- nonfasting; symptoms or endoscopic evidence of gastroesophageal reflux, of gastric ulcer, or oropharyngeal pathology; known or predicted difficult airway; allergy to anesthetic and nonsteroidal antiinflammatory drugs; or inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the ProSeal Laryngeal Mask and I-gel as a Temporary Ventilatory Device Before Tracheal Intubation in Morbidly Obese Patients
Investigators study the performance of both masks, Proseal Laryngeal Mask Airway (PLMA) and I-gel, as temporary ventilatory supraglottic airway devices (SGDs) before tracheal intubation in morbidly obese patients. Data are lacking in such population of patients
Read the detailed description
The available data regarding SGDs in morbidly obese patients have focused mainly on PLMA. In general, SGDs have been successfully used as temporary ventilatory devices before laryngoscope-guided tracheal intubation, conduits for endotracheal tube insertion, and primary airway devices during surgery. Second-generation SGDs are preferred for both rescue airway and routine use, compared with first-generation, non-gastric access devices. Data on comparison PLMA vs. I-gel in morbidly obese patient are lacking.
The PLMA is a second generation gastric access SGD. PLMA is composed of an airway tube that connects to a mask which, after insertion through the patient's mouth and inflation of cuff, forms an airtight seal on top the glottis allowing a secure airway to be managed by a health care provider. PLMA can be autoclaved and reused many times. I-gel is a new type of single use, second generation, gastric access SGD 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 PLMA and I-gel regarding insertion success rate, the time of insertion, gastric access tube positioning, oropharyngeal leak pressure, assessment of position by fiberoptic, ventilatory parameters and hemodynamic, and complications for each device placed before tracheal intubation in morbidly obese patients.
This study is conducted at University Medical Hospital of Padova, with approval from Hospital research Ethical Committee and written informed consents from patients,. Patients are randomly allocated into 2 equal groups, according to the inclusion and exclusion criteria.
PLMA (n=35) in which PLMA is used for ventilation. I-gel (n=35) in which I-gel is used for ventilation.
I
- Conditions
- Morbid Obesity
- Being tested
- Supraglottic device (SGD)
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supraglottic device (SGD)Device
Positioning of SGD as temporary ventilatory device before tracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| PLMA | Active comparator | The PLMA, a second generation gastric access SGD, is used as temporary ventilatory device before tracheal intubation. Performance is evaluated. Receives: Device: Supraglottic device (SGD) |
| I-gel | Active comparator | The I-gel, a second generation gastric access SGD, is used as temporary ventilatory device before tracheal intubation. Performance is evaluated. Receives: Device: Supraglottic device (SGD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal leak pressure (OLP)
OLP is defined as the anesthesia circuit pressure at which a gas leak occurs around the SGD
Measured: Procedure (After correct placement of SGD)
Secondary outcomes (5)
Time insertion
Time for definitive placement of SGD
Measured: Procedure (Time from pick up to correct placement of SGD)
SGD placement
Ease of insertion of the SGD
Measured: Procedure (From pick up to correct placement of SGD)
Gastric tube
Ease of insertion of the gastric tube through the dedicated conduit
Measured: Procedure (After correct placement of SGD)
fiberoptic evaluation
Fiberoptic evaluation of correct positioning through SGD
Measured: Procedure (After correct placement of SGD and established ventilation)
Leak fraction
The leak fraction is defined as the leak volume divided by the inspired tidal volume.
Measured: Procedure (After correct placement of SGD and established ventilation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start15 Feb 2021
- Primary completion15 Mar 2022 (estimated)
- Study completion15 Jun 2022 (estimated)
Why it stopped: Device (ProSeal Laryngeal Mask Airway) no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- 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 PLMA and I-gel are both effective as temporary ventilatory device in morbidly obese patients.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michele Carron, MD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243564
- Sponsor's protocol ID
- 3793AO16
- Status last verified
- Jan 2021
- First submitted
- 24 Jan 2020
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gasteiger L, Brimacombe J, Perkhofer D, Kaufmann M, Keller C. Comparison of guided insertion of the LMA ProSeal vs the i-gel. Anaesthesia. 2010 Sep;65(9):913-6. doi: 10.1111/j.1365-2044.2010.06422.x.
PubMed 20645948Keller C, Brimacombe J, Kleinsasser A, Brimacombe L. The Laryngeal Mask Airway ProSeal(TM) as a temporary ventilatory device in grossly and morbidly obese patients before laryngoscope-guided tracheal intubation. Anesth Analg. 2002 Mar;94(3):737-40; table of contents. doi: 10.1097/00000539-200203000-00048.
PubMed 11867408Van Zundert TC, Brimacombe JR. Similar oropharyngeal leak pressures during anaesthesia with i-gel, LMA-ProSeal and LMA-Supreme Laryngeal Masks. Acta Anaesthesiol Belg. 2012;63(1):35-41.
PubMed 22783708Maitra S, Baidya DK, Arora MK, Bhattacharjee S, Khanna P. Laryngeal mask airway ProSeal provides higher oropharyngeal leak pressure than i-gel in adult patients under general anesthesia: a meta-analysis. J Clin Anesth. 2016 Sep;33:298-305. doi: 10.1016/j.jclinane.2016.04.020. Epub 2016 May 18.
PubMed 27555181
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the ProSeal Laryngeal Mask and I-gel as a Temporary Ventilatory Device Before Tracheal Intubation in Morbidly Obese Patients
- ClinicalTrials.gov ID
- NCT04243564
- Acronym / sponsor ID
- 3793AO16
- Conditions
- Morbid Obesity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Device (ProSeal Laryngeal Mask Airway) no longer available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 15 Mar 2022 (estimated)
- Study completion
- 15 Jun 2022 (estimated)
- First posted
- 28 Jan 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.
Investigators study the performance of both masks, Proseal Laryngeal Mask Airway (PLMA) and I-gel, as temporary ventilatory supraglottic airway devices (SGDs) before tracheal intubation in morbidly obese patients. Data are lacking in such population of patients
Detailed description
The available data regarding SGDs in morbidly obese patients have focused mainly on PLMA. In general, SGDs have been successfully used as temporary ventilatory devices before laryngoscope-guided tracheal intubation, conduits for endotracheal tube insertion, and primary airway devices during surgery. Second-generation SGDs are preferred for both rescue airway and routine use, compared with first-generation, non-gastric access devices. Data on comparison PLMA vs. I-gel in morbidly obese patient are lacking.
The PLMA is a second generation gastric access SGD. PLMA is composed of an airway tube that connects to a mask which, after insertion through the patient's mouth and inflation of cuff, forms an airtight seal on top the glottis allowing a secure airway to be managed by a health care provider. PLMA can be autoclaved and reused many times. I-gel is a new type of single use, second generation, gastric access SGD 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 PLMA and I-gel regarding insertion success rate, the time of insertion, gastric access tube positioning, oropharyngeal leak pressure, assessment of position by fiberoptic, ventilatory parameters and hemodynamic, and complications for each device placed before tracheal intubation in morbidly obese patients.
This study is conducted at University Medical Hospital of Padova, with approval from Hospital research Ethical Committee and written informed consents from patients,. Patients are randomly allocated into 2 equal groups, according to the inclusion and exclusion criteria.
PLMA (n=35) in which PLMA is used for ventilation. I-gel (n=35) in which I-gel is used for ventilation.
I
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Investigators hypothesize PLMA and I-gel are both effective as temporary ventilatory device in morbidly obese patients.
| Arm | Type | Receives |
|---|---|---|
| PLMA | Active comparator | Device: Supraglottic device (SGD)The PLMA, a second generation gastric access SGD, is used as temporary ventilatory device before tracheal intubation. Performance is evaluated. |
| I-gel | Active comparator | Device: Supraglottic device (SGD)The I-gel, a second generation gastric access SGD, is used as temporary ventilatory device before tracheal intubation. Performance is evaluated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- morbidly obese patients scheduled for elective bariatric surgery under general anesthesia
Key exclusion criteria (1 listed)
- nonfasting; symptoms or endoscopic evidence of gastroesophageal reflux, of gastric ulcer, or oropharyngeal pathology; known or predicted difficult airway; allergy to anesthetic and nonsteroidal antiinflammatory drugs; or inability to provide informed consent.
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 |
|---|---|---|
| Supraglottic device (SGD)Positioning of SGD as temporary ventilatory device before tracheal intubation | Device | I-gel, PLMA |
Primary outcome
Oropharyngeal leak pressure (OLP)
Time frame: Procedure (After correct placement of SGD)
OLP is defined as the anesthesia circuit pressure at which a gas leak occurs around the SGD
5 secondary outcomes
Time insertion
Time frame: Procedure (Time from pick up to correct placement of SGD)
SGD placement
Time frame: Procedure (From pick up to correct placement of SGD)
Gastric tube
Time frame: Procedure (After correct placement of SGD)
fiberoptic evaluation
Time frame: Procedure (After correct placement of SGD and established ventilation)
Leak fraction
Time frame: Procedure (After correct placement of SGD and established ventilation)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Results publication: PubMed 20645948Gasteiger L, Brimacombe J, Perkhofer D, Kaufmann M, Keller C. Comparison of guided insertion of the LMA ProSeal vs the i-gel. Anaesthesia. 2010 Sep;65(9):913-6. doi: 10.1111/j.1365-2044.2010.06422.x.
- Results publication: PubMed 11867408Keller C, Brimacombe J, Kleinsasser A, Brimacombe L. The Laryngeal Mask Airway ProSeal(TM) as a temporary ventilatory device in grossly and morbidly obese patients before laryngoscope-guided tracheal intubation. Anesth Analg. 2002 Mar;94(3):737-40; table of contents. doi: 10.1097/00000539-200203000-00048.
- Results publication: PubMed 22783708Van Zundert TC, Brimacombe JR. Similar oropharyngeal leak pressures during anaesthesia with i-gel, LMA-ProSeal and LMA-Supreme Laryngeal Masks. Acta Anaesthesiol Belg. 2012;63(1):35-41.
- Results publication: PubMed 27555181Maitra S, Baidya DK, Arora MK, Bhattacharjee S, Khanna P. Laryngeal mask airway ProSeal provides higher oropharyngeal leak pressure than i-gel in adult patients under general anesthesia: a meta-analysis. J Clin Anesth. 2016 Sep;33:298-305. doi: 10.1016/j.jclinane.2016.04.020. Epub 2016 May 18.
- Individual participant dataSharing planned: No
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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.
Michele Carron, MD principal investigator
University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supraglottic device (SGD) in people with Morbid Obesity, run by University of Padova at 1 site in Italy.
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: withdrawn, as of the sponsor's last update on 5 Dec 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 Italy. 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 was withdrawn before enrolling participants, so there are no results.
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?
Oropharyngeal leak pressure (OLP) (time frame: Procedure (After correct placement of SGD)). 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 NCT04243564, which also lists 4 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 5 Dec 2023.