NCT04243564

Brief 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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

December 5, 2023

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

January 24, 2020

Last Update Submit

November 28, 2023

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

  • Oropharyngeal leak pressure (OLP)

    OLP is defined as the anesthesia circuit pressure at which a gas leak occurs around the SGD

    Procedure (After correct placement of SGD)

Secondary Outcomes (5)

  • Time insertion

    Procedure (Time from pick up to correct placement of SGD)

  • SGD placement

    Procedure (From pick up to correct placement of SGD)

  • Gastric tube

    Procedure (After correct placement of SGD)

  • fiberoptic evaluation

    Procedure (After correct placement of SGD and established ventilation)

  • Leak fraction

    Procedure (After correct placement of SGD and established ventilation)

Study Arms (2)

PLMA

ACTIVE COMPARATOR

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

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.

Device: Supraglottic device (SGD)

Interventions

Supraglottic device (SGD)DEVICE

Positioning of SGD as temporary ventilatory device before tracheal intubation

I-gelPLMA

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Padiua Hospital

Padua, 35128, Italy

Location

Related Publications (4)

  • 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.

    PMID: 20645948RESULT

  • 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.

    PMID: 11867408RESULT

  • 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.

    PMID: 22783708RESULT

  • 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.

    PMID: 27555181RESULT

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michele Carron, MD

    University of Padova

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Investigators hypothesize PLMA and I-gel are both effective as temporary ventilatory device in morbidly obese patients.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2020

First Posted

January 28, 2020

Study Start

February 15, 2021

Primary Completion

March 15, 2022

Study Completion

June 15, 2022

Last Updated

December 5, 2023

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)