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Oropharyngeal Leak Pressure Monitoring Using Baska Versus I-gel Laryngeal Mask Airway

Oropharyngeal Leak Pressure Monitoring With Baska Versus I-gel Laryngeal Mask Airway During Laparoscopic Gynecologic Surgery

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03725540
Enrollment
80
Registered
2018-10-31
Start date
2018-11-01
Completion date
2021-11-30
Last updated
2021-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngeal Masks

Keywords

Laryngeal Masks, Oropharyngeal leak pressure, I-gel laryngeal mask airway

Brief summary

The use of supraglottic airway devices with a gastric emptying tube in gynecological laparoscopic surgeries is growing. In addition to their ease of placement, they have low airway morbidity along with sufficient airway pressure in the Trendelenburg position and so they have been determined as an alternative to the endotracheal tube.

Detailed description

The Baska mask is a novel supraglottic airway device with a non-inflatable cuff, an oesophageal drainage inlet and side channels to facilitate the aspiration of gastric contents and an integrated bite-block. The Baska mask comes in four sizes, ranging from pediatric to adult. The device appeared relatively easy to insert, provided a high-quality seal with the glottic aperture and the incidence of throat discomfort appeared low. The I-gel a single use with noninflatable cuff and drain tube is being used for airway management during anesthesia since last few years. The noninflatable cuff of I-gel is made of a soft gel-like medical grade thermoplastic elastomer. The device has a buccal cavity stabilizer, an integral bite block and an epiglottic rest with a protective ridge, which prevents down folding of epiglottis during insertion. An oropharyngeal leak pressure or 'leak' test is commonly performed with the laryngeal mask airway to quantify the efficacy of the seal with the airway. This value is important since it indicates the feasibility of positive pressure ventilation and the degree of airway protection from supracuff soiling. Gynecological laparoscopic surgeries are associated with a decrease in thoraco-pulmonary compliance due to pneumoperitoneum and the Trendelenburg position. Minute ventilation needs to be increased to compensate for this reduction in compliance in order to maintain end-tidal carbon dioxide during pneumoperitoneum. This increase in minute ventilation can lead to an increase in airway pressures in excess of 20 cmH2O.

Interventions

DEVICEI-gel

Patients will be anesthetized using an appropriate sized I-gel mask according to the manufacturer's recommendations after lubrication with a water-soluble lubricant.

DEVICEBaska_mask

Patients will be anesthetized using BASKA mask after lubrication with a water-soluble lubricant.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* BMI\< 30kg/m2. * ASA physical status: I-II. * Operation: gynecological laparoscopic surgery * under general anesthesia of an anticipated duration\<1h.

Exclusion criteria

* Patient refusal. * History of cardiac disease, psychological disorders, respiratory diseases including asthma, renal or hepatic failure. * Patients who have a high risk of regurgitation or aspiration based on a history of gastroesophageal reflux, hiatus hernia, diabetes and gross obesity. * Neck pathology

Design outcomes

Primary

MeasureTime frameDescription
Leak airway pressureIntra-operative; after device insertion up to its removalcmH2O

Secondary

MeasureTime frameDescription
Peak airway pressureIntra-operative; after device insertion up to its removalcmH2O

Countries

Egypt

Contacts

Primary ContactHala S Abdel-Ghaffar, MD
hallasaad@yahoo.com01003812011
Backup Contactghada aboelfadl, MD
ghadafadl77@gmail.com01005802086

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026