MedDataX Logo

Laryngeal Mask in Morbid Obesity

NCT ID: NCT04243564

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2022-06-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Morbid Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Investigators hypothesize PLMA and I-gel are both effective as temporary ventilatory device in morbidly obese patients.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PLMA

The PLMA, a second generation gastric access SGD, is used as temporary ventilatory device before tracheal intubation. Performance is evaluated.

Group Type ACTIVE_COMPARATOR

Supraglottic device (SGD)

Intervention Type DEVICE

Positioning of SGD as temporary ventilatory device before tracheal intubation

I-gel

The I-gel, a second generation gastric access SGD, is used as temporary ventilatory device before tracheal intubation. Performance is evaluated.

Group Type ACTIVE_COMPARATOR

Supraglottic device (SGD)

Intervention Type DEVICE

Positioning of SGD as temporary ventilatory device before tracheal intubation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Supraglottic device (SGD)

Positioning of SGD as temporary ventilatory device before tracheal intubation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* morbidly obese patients scheduled for elective bariatric surgery under general anesthesia

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Padova

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michele Carron, MD

Role: PRINCIPAL_INVESTIGATOR

University of Padova

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Padiua Hospital

Padua, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 20645948 (View on PubMed)

Keller 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.

Reference Type RESULT
PMID: 11867408 (View on PubMed)

Van 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.

Reference Type RESULT
PMID: 22783708 (View on PubMed)

Maitra 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.

Reference Type RESULT
PMID: 27555181 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3793AO16

Identifier Type: -

Identifier Source: org_study_id