Clinical trial NCT03725540: Oropharyngeal Leak Pressure Monitoring Using Baska Versus I-gel Laryngeal Mask Airway
Official title: Oropharyngeal Leak Pressure Monitoring With Baska Versus I-gel Laryngeal Mask Airway During Laparoscopic Gynecologic Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Laryngeal Masks
Keywords: Laryngeal Masks
Oropharyngeal leak pressure
I-gel laryngeal mask airway
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Females, aged 18-60 years, BMI\< 30kg/m2.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Leak airway pressure
timeFrame: Intra-operative; after device insertion up to its removal
Secondary outcomes:
measure: Peak airway pressure
timeFrame: Intra-operative; after device insertion up to its removal
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: woman health hospital , Assiut university
Study officials:
affiliation: Professor of anesthesia, faculty of medicine, Assiut university, Egypt.
name: Hala Abdelghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmidbauer W, Bercker S, Volk T, Bogusch G, Mager G, Kerner T. Oesophageal seal of the novel supralaryngeal airway device I-Gel in comparison with the laryngeal mask airways Classic and ProSeal using a cadaver model. Br J Anaesth. 2009 Jan;102(1):135-9. doi: 10.1093/bja/aen319. Epub 2008 Nov 16.
citation: Joshi NA, Baird M, Cook TM. Use of an i-gel for airway rescue. Anaesthesia. 2008 Sep;63(9):1020-1. doi: 10.1111/j.1365-2044.2008.05668.x. No abstract available.
citation: Alexiev V, Salim A, Kevin LG, Laffey JG. An observational study of the Baska(R) mask: a novel supraglottic airway. Anaesthesia. 2012 Jun;67(6):640-5. doi: 10.1111/j.1365-2044.2012.07140.x.
citation: Pandit JJ. If it hasn't failed, does it work? On 'the worst we can expect' from observational trial results, with reference to airway management devices. Anaesthesia. 2012 Jun;67(6):578-83. doi: 10.1111/j.1365-2044.2012.07155.x. No abstract available.
citation: Janakiraman C, Chethan DB, Wilkes AR, Stacey MR, Goodwin N. A randomised crossover trial comparing the i-gel supraglottic airway and classic laryngeal mask airway. Anaesthesia. 2009 Jun;64(6):674-8. doi: 10.1111/j.1365-2044.2009.05898.x.