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

NCT ID: NCT03725540

Last Updated: 2021-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2021-11-30

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.

Conditions

Laryngeal Masks

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

I-gel

Intervention Type: DEVICE

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

BASKA Group

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

Baska_mask

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Baska_mask

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

Intervention Type: DEVICE

Other Intervention Names

I-gel LMA; The Baska_ LMA

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Hala Saad Abdel-Ghaffar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala Abdelghaffar, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of anesthesia, faculty of medicine, Assiut university, Egypt.

Locations

woman health hospital , Assiut university

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Hala S Abdel-Ghaffar, MD

Role: CONTACT

hallasaad@yahoo.com

01003812011

ghada aboelfadl, MD

Role: CONTACT

ghadafadl77@gmail.com

01005802086

Facility Contacts

Ghada M Aboelfadl, MD

Role: primary

ghadafadl77@gmail.com

01005802086

References

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.

Reference Type: BACKGROUND

PMID: 19011262 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18699884 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22563956 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22563955 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19453322 (View on PubMed)

Other Identifiers

17300223

Identifier Type: -

Identifier Source: org_study_id