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

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.

Study Overview

• Status: Recruiting
• Conditions: Laryngeal Masks
• Intervention / Treatment: Device: I-gel; Device: Baska_mask

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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Hala S Abdel-Ghaffar, MD; Phone Number: 01003812011; Email: hallasaad@yahoo.com
• Study Contact Backup: Name: ghada aboelfadl, MD; Phone Number: 01005802086; Email: ghadafadl77@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Recruiting
    • woman health hospital , Assiut university
    • Contact: Ghada M Aboelfadl, MD; Phone Number: 01005802086; Email: ghadafadl77@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
I-gel group; Patients will be anesthetized using an appropriate sized I-gel mask according to the manufacturer's recommendations after lubrication with a water-soluble lubricant.	Device: I-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.; Other Names: I-gel LMA
BASKA Group; Patients will be anesthetized using BASKA mask after lubrication with a water-soluble lubricant.	Device: Baska_mask; Patients will be anesthetized using BASKA mask after lubrication with a water-soluble lubricant.; Other Names: The Baska_ LMA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leak airway pressure	cmH2O	Intra-operative; after device insertion up to its removal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak airway pressure	cmH2O	Intra-operative; after device insertion up to its removal

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Hala Abdelghaffar, MD, Professor of anesthesia, faculty of medicine, Assiut university, Egypt.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: July 28, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Laryngeal Masks; Oropharyngeal leak pressure; I-gel laryngeal mask airway
• Other Study ID Numbers: 17300223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No